121 results on '"Mcnay, Laura"'
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2. 32 Launching a Clinical Research Operation
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Larson, Gregg, McNay, Laura A., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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3. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
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Group, ACTIV-3 Therapeutics for Inpatients with COVID-19 Study, Self, Wesley H, Sandkovsky, Uriel, Reilly, Cavan S, Vock, David M, Gottlieb, Robert L, Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R, Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R, Hibbert, Kathryn A, Rice, Todd W, Casey, Jonathan D, Hayanga, J Awori, Badhwar, Vinay, Leshnower, Bradley G, Sharifpour, Milad, Knowlton, Kirk U, Peltan, Ithan D, Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E, Sturek, Jeffrey M, Rogers, Angela J, Files, D Clark, Mosier, Jarrod M, Gong, Michelle N, Douin, David J, Hite, R Duncan, Trautner, Barbara W, Jain, Mamta K, Gardner, Edward M, Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A, Ginde, Adit A, Brown, Samuel M, Higgs, Elizabeth S, Pett, Sarah, Weintrob, Amy C, Chang, Christina C, Murrary, Daniel D, Günthard, Huldrych F, Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Thompson, B Taylor, Gelijns, Annetine C, Neaton, James D, Lane, H Clifford, Jundgren, Jens D, Tierney, John, Barrett, Kevin, Herpin, Betsey R, Smolskis, Mary C, Voge, Susan E, McNay, Laura A, Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J, Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, and Murray, Thomas
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Clinical Trials and Supportive Activities ,Lung ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,Antibodies ,Monoclonal ,Antibodies ,Monoclonal ,Humanized ,Antibodies ,Neutralizing ,Double-Blind Method ,Female ,Humans ,Male ,Middle Aged ,SARS-CoV-2 ,Treatment Outcome ,COVID-19 Drug Treatment ,ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group ,Clinical Sciences ,Medical Microbiology ,Public Health and Health Services ,Microbiology - Abstract
BackgroundWe aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.MethodsIn this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FindingsBetween Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.InterpretationNeither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FundingUS National Institutes of Health and Operation Warp Speed.
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- 2022
4. SARS-CoV-2 seroprevalence in vaccine-naïve participants from the Democratic Republic of Congo, Guinea, Liberia, and Mali
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Akpa, Esther, Bah, Fatoumata Binta, Barash, Yi-Chi, Beavogui, Abdoul Habib, Biampata, Jean-Luc, Bonnett, Tyler, Brown, Shawn, Burkey, Alissa, Camara, Daouda, Camara, Sekou, Cline-Cole, Elfrida, Coulibaly, Mamadou D, Coulibaly, Nadie, Dewar, Robin, Diallo, Mountaga, Diarra, Samba, Doumbia, Seydou, Eyler, Allison, Fouth Tchos, Karine, Francis, Alyson, Grue, Louis, Highbarger, Helene, Highbarger, Jeroen, Ibanda, Augustin Mbala, Kallon, Kadé, Kindombe, Esaie Luzolu, Kingebeni, Placide Mbala, Kolié, Cece Francis, Lallemand, Perrine, Lim, Caeul, Lokilo, Emmanuel, Lumembe, Raphael, McCormack, Ashley Louise, McNay, Laura, Mukendi, Gael, Mukendi, Thierry, Muyembe, Jean Jacques, Newell, Kevin, Njoh, Wissedi, Pankwa, Isaac Balmayel, Pukuta, Elisabeth, Riziki, Yogolelo, Rupert, Adam, Samake, Seydou, Sandrus, Jennifer, Sangare, Adama, Smolskis, Mary, Souto Adeva, Gema, Stevens, Randy, Tangara, Cheick Oumar, Tounkara, Moctar, Trumbull-Kennedy, Meghan, Tshomba, Antoine, Wague, Mamadou, Weyers, Shera, Worthington, Chris, Laverdure, Sylvain, Kazadi, Donatien, Kone, Kadidia, Callier, Viviane, Dabitao, Djeneba, Dennis, Dehkontee, Haidara, Mory Cherif, Hunsberger, Sally, Mbaya, Olivier Tshiani, Ridzon, Renee, Sereti, Irini, and Shaw-Saliba, Katy
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- 2024
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5. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial
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Group, The ITAC Study, Polizzotto, Mark N, Nordwall, Jacqueline, Babiker, Abdel G, Phillips, Andrew, Vock, David M, Eriobu, Nnakelu, Kwaghe, Vivian, Paredes, Roger, Mateu, Lourdes, Ramachandruni, Srikanth, Narang, Rajeev, Jain, Mamta K, Lazarte, Susana M, Baker, Jason V, Frosch, Anne EP, Poulakou, Garyfallia, Syrigos, Konstantinos N, Arnoczy, Gretchen S, McBride, Natalie A, Robinson, Philip A, Sarafian, Farjad, Bhagani, Sanjay, Taha, Hassan S, Benfield, Thomas, Liu, Sean TH, Antoniadou, Anastasia, Jensen, Jens Ulrik Stæhr, Kalomenidis, Ioannis, Susilo, Adityo, Hariadi, Prasetyo, Jensen, Tomas O, Morales-Rull, Jose Luis, Helleberg, Marie, Meegada, Sreenath, Johansen, Isik S, Canario, Daniel, Fernández-Cruz, Eduardo, Metallidis, Simeon, Shah, Amish, Sakurai, Aki, Koulouris, Nikolaos G, Trotman, Robin, Weintrob, Amy C, Podlekareva, Daria, Hadi, Usman, Lloyd, Kathryn M, Røge, Birgit Thorup, Saito, Sho, Sweerus, Kelly, Malin, Jakob J, Lübbert, Christoph, Muñoz, Jose, Cummings, Matthew J, Losso, Marcelo H, Turner, Dan, Shaw-Saliba, Kathryn, Dewar, Robin, Highbarger, Helene, Lallemand, Perrine, Rehman, Tauseef, Gerry, Norman, Arlinda, Dona, Chang, Christina C, Grund, Birgit, Holbrook, Michael R, Holley, Horace P, Hudson, Fleur, McNay, Laura A, Murray, Daniel D, Pett, Sarah L, Shaughnessy, Megan, Smolskis, Mary C, Touloumi, Giota, Wright, Mary E, Doyle, Mittie K, Popik, Sharon, Hall, Christine, Ramanathan, Roshan, Cao, Huyen, Mondou, Elsa, Willis, Todd, Thakuria, Joseph V, Yel, Leman, Higgs, Elizabeth, Kan, Virginia L, Lundgren, Jens D, Neaton, James D, and Lane, H Clifford
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Biomedical and Clinical Sciences ,Clinical Sciences ,Prevention ,Emerging Infectious Diseases ,Clinical Research ,Vaccine Related ,Clinical Trials and Supportive Activities ,Lung ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adenosine Monophosphate ,Alanine ,Antibodies ,Neutralizing ,Antiviral Agents ,COVID-19 ,COVID-19 Vaccines ,Double-Blind Method ,Female ,Hospitalization ,Humans ,Inpatients ,Internationality ,Male ,Middle Aged ,Treatment Outcome ,Vaccines ,Inactivated ,ITAC (INSIGHT 013) Study Group ,Medical and Health Sciences ,General & Internal Medicine ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundPassive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited.MethodsIn this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581.FindingsFrom Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77-1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66-1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14-4·29); for patients who were antibody negative, the OR was 0·51 (0·29-0·90; pinteraction=0·001).InterpretationWhen administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry.FundingUS National Institutes of Health.
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- 2022
6. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial
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Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, Wenner, Christine, Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, and Lane, H Clifford
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- 2023
- Full Text
- View/download PDF
7. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
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Self, Wesley H., Sandkovsky, Uriel, Reilly, Cavan S., Vock, David M., Gottlieb, Robert L., Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R., Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R., Hibbert, Kathryn A., Rice, Todd W., Casey, Jonathan D., Hayanga, J. Awori, Badhwar, Vinay, Leshnower, Bradley G., Sharifpour, Milad, Knowlton, Kirk U., Peltan, Ithan D., Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E., Sturek, Jeffrey M., Rogers, Angela J., Files, D. Clark, Mosier, Jarrod M., Gong, Michelle N., Douin, David J., Hite, R. Duncan, Trautner, Barbara W., Jain, Mamta K., Gardner, Edward M., Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A., Ginde, Adit A., Brown, Samuel M., Higgs, Elizabeth S., Pett, Sarah, Weintrob, Amy C., Chang, Christina C., Murrary, Daniel D., Günthard, Huldrych F., Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N., Babiker, Abdel G., Davey, Victoria J., Kan, Virginia, Thompson, B. Taylor, Gelijns, Annetine C., Neaton, James D., Lane, H. Clifford, Jundgren, Jens D., Tierney, John, Barrett, Kevin, Herpin, Betsey R., Smolskis, Mary C., Voge, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J., Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, Murray, Thomas, Quan, Kien, Quan, Siu Fun, Thompson, Greg, Walski, Jamie, Wentworth, Deborah, Moskowitz, Alan J., Bagiella, Emilia, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Berhe, Mezgebe, Haley, Clinton, Bettacchi, Christopher, Duhaime, Erin, Ryan, Madison, Burris, Sarah, Jones, Felecia, Villa, Samantha, Want, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Marian, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Dreyer, Grace R., Witte, Marie, Mosaly, Nilima, Mourad, Ahmad, Holland, Thomas L., Lane, Kathleen, Bouffler, Andrew, McGowan, Lauren M., Motta, Marry, Tipton, Gregory, Stallings, Ben, Stout, Gennifer, McLendon-Arvik, Beth, Hollister, Beth A., Giangiacomo, Dana M., Sharma, Sunil, Pappers, Brian, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresio, Lisa, Glaze, Chad, Evans, Raquel, Preamble, Katarina, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Bartolo, Elizabeth Berry, Williams, Roger, Bunner, Robin, Bender, William, Miller, Jeffrey, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elizabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, May M., Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Lozano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Possemato, Tammie, Escobar, Jose, Chiu, Charlene, Weissman, Kevin, Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Jonathan, Vonderhaar, Derek, Nossaman, Bobby, Laudun, Sylvia, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Maroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberley, Audette, Matthew, Fleischmann, Emily, Akbari, Freshta, Lee, Maia, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Caccia, Taylor, Johnson, Haley, Newton, Crystallee, Parr, Doug, Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Fitzgerald, Laura, Morin, Haley D., Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Aggarwal, Neil R., Bienstock, Karen, Hou, Peter, Steingrub, Jay, Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Banner-Goodspeed, Valerie, Boyle, Katherine L., Hayes, Sharon, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah K., Parry, Blair Alden, Margolin, Justin D., Brait, Kelsey, Beakes, Caroline, Kangelaris, Kirsten N., Yee, Kimberly J., Ashktorab, Kimia, Jauregui, Alejandra E., Zhuo, Hanjing, Hendey, Gregory, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Wilson, Jennifer G., Vojnik, Rosemary, Roque, Jonasel, Perez, Cynthia, Lim, George W., Chang, Steven Y., Beutler, Rebecca, Agarwal, Trisha, Vargas, Julia, Moss, Marc, Baduashvili, Amiran, Chauhan, Lakshmi, Finck, Lani L., Howell, Michelle, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jia, Shijing, Sullins, Barbara, Hanna, Sinan, Olbrich, Norman, Richardson, Lynne D., Nair, Rahul, Offor, Obiageli, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Terndrup, Thomas E., Wiedemann, Herbert P., Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Hudock, Kristin, Kiran, Simra, More, Harshada, Roads, Tammy, Martinkovic, Jamie, Kennedy, Sarah, Robinson, Bryce H., Hough, Catherine L., Krol, Olivia F., Kinjal, Mistry, Mills, Emmanuel, McDougal, Madeline, Deshmukh, Rupali, Chen, Peter, Torbati, Sam S., Matusov, Yuri, Choe, June, Hindoyan, Niree A., Jackman, Susan E., Bayoumi, Emad, Wynter, Timothy, Caudill, Antonina, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Mehdikhani, Shaunt, O'Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Miller, Chadwick, Gibbs, Keven W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sara N., Mayer, Kirby P., Bissel, Brittany, Bledsoe, Joseph, Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Armbruster, Brent P., Montgomery, Quinn, Applegate, Darrin, Kumar, Naresh, Fergus, Melissa, Serezlic, Erna, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Aston, Valerie T., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Sánchez, Adriana, Popielski, Laura, Rivasplata, Heather, Turner, Melissa, Vjecha, Michael, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Lucas, Claudia Sanchez, DellaValle, Natalie, Gonzales, Sonia, Scott, James, Wyles, David, Douglas, Ivor, Haukoos, Jason, Kamis, Kevin, Robinson, Caitlin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Markowitz, Norman, Pastor, Erika, Ramesh, Mayur, Brar, Indira, Rivers, Emanuel, Kumar, Princy, Menna, Maximiliano, Biswas, Kousick, Harrington, Cristin, Delp, Alex, Pandit, Lavannya, Hines-Munson, Casey, Van, John, Dillon, Laura, Want, Yiqun, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Roller, Brentin, Nguyen, Chinh, Mikail, Amani, Raben, Dorthe, Jensen, Tomas O., Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esmann, Frederik V.L., Clausen, Clara Lundetoft, Hovmand, Nichlas, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Høgsberg, Dorthe S., Rastoder, Ema, Kamstrup, Thobias, Bergsøe, Christina Marisa, Østergaard, Lars, Stærke, Nina Breinholt, Johansen, Isik S., Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Helleberg, Marie, Gerstoft, Jan, Jensen, Tomas Østergaard, Lindegaard, Birgitte, Pedersen, Thomas Ingemann, Røge, Birgit Thorup, Løfberg, Sandra Valborg, Hansen, Thomas Michael, Nielsen, Ariella Denize, von Huth, Sebastian Leicht, Nielsen, Henrik, Thisted, Rikke Krog, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Lindnér, Cecilia Ebba Clara Ellinor, Wiese, Lothar, Knudsen, Lene Surland, Nytofte, Nikolaj Julian Skrøder, Havmøller, Signe Ravn, Paredes, Roger, Exposito, Maria, Fernández-Cruz, Eduardo, Muñoz, José, Arribas, Jose R., Estrada, Vicente, Horcajada, Juan P., Burgos, Joaquin, Morales-Rull, Jose Luis, Braun, Dominique L., West, Emily, M'Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, Horban, Andrzej, Bednarska, Agnieszka, Jurek, Natalia, Fätkenheuer, Gerd, Malinm, Jakob J., Matthews, Gail, Kelleher, Anthony, Cabrera, Gesalit, Carey, Catherine, Hough, Sally, Virachit, Sophie, Zhong, Amy, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David, Ong, Sean, Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Hudson, Fleur, Parmar, Mahesh KB, Goodman, Anna, Badrock, Jonathan, Gregory, Adam, Harris, Nicola, Touloumi, Giota, Pantaz, Nikos, Gioukari, Vicky, Lutaakome, Joseph, Kityo, Cissy M., Mugerwa, Henry, Kiweewa, Francis, Osinusi, Anu, Tipple, Craig, Willis, Angela, Peppercorn, Amanda, Watson, Helen, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Adams, Amy, Albert, Sara, Balde, Abby, Baracz, Michelle, Baseler, Beth, Becker, Nancy, Bielica, Mona, Billouin-Frazier, Shere, Cash, Jennifer, Choudhary, Jay, Dolney, Suzanne, Dixon, Mary, Eyler, Carolyn, Frye, Leanna, Galcik, Michael, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hissey, Debbie, Hogarty, Debi, Hohn, Matt, Holley, H Preston, Hoopengardner, Lisa, Huber, Lynda, Jankelevich, Shirley, Krauss, Gary, Lake, Eileen, Linton, Jessica, MacDonald, Leah, Manandhar, Meryan, Spinelli-Nadzam, Mary, Oluremi, Charles, Proffitt, Calvin, Rudzinski, Erin, Sandrus, Jen, Schaffhauser, Marylu, Schechner, Adam, Suders, Connie, Gerry, Norman P., Smith, Kenneth, Solomon, Courtney, Kubernac, Amanda, Rashid, Marium, Patel, Bhakti, Kubernac, Robert, Murphy, Joseph, Hoover, Marie L., Brown, Craig, DuChateau, Nadine, Flosi, Adam, Johnson, Les, Treagus, Amy, and Wenner, Christine
- Published
- 2022
- Full Text
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8. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial
- Author
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Polizzotto, Mark N., Nordwall, Jacqueline, Babiker, Abdel G., Phillips, Andrew, Vock, David M., Eriobu, Nnakelu, Kwaghe, Vivian, Paredes, Roger, Mateu, Lourdes, Ramachandruni, Srikanth, Narang, Rajeev, Jain, Mamta K., Lazarte, Susana M., Baker, Jason V., Frosch, Anne E.P., Poulakou, Garyfallia, Syrigos, Konstantinos N., Arnoczy, Gretchen S., McBride, Natalie A., Robinson, Philip A., Sarafian, Farjad, Bhagani, Sanjay, Taha, Hassan S., Benfield, Thomas, Liu, Sean T.H., Antoniadou, Anastasia, Jensen, Jens Ulrik Stæhr, Kalomenidis, Ioannis, Susilo, Adityo, Hariadi, Prasetyo, Jensen MD, Tomas O., Morales-Rull, Jose Luis, Helleberg, Marie, Meegada, Sreenath, Johansen, Isik S., Canario, Daniel, Fernández-Cruz, Eduardo, Metallidis, Simeon, Shah, Amish, Sakurai, Aki, Koulouris, Nikolaos G., Trotman, Robin, Weintrob, Amy C., Podlekareva, Daria, Hadi, Usman, Lloyd, Kathryn M., Røge, Birgit Thorup, Saito, Sho, Sweerus, Kelly, Malin, Jakob J., Lübbert, Christoph, Muñoz, Jose, Cummings, Matthew J., Losso, Marcelo H., Turner, Dan, Shaw-Saliba, Kathryn, Dewar, Robin, Highbarger, Helene, Lallemand, Perrine, Rehman, Tauseef, Gerry, Norman, Arlinda, Dona, Chang, Christina C., Grund, Birgit, Holbrook, Michael R., Holley, Horace P., Hudson, Fleur, McNay, Laura A., Murray, Daniel D., Pett, Sarah L., Shaughnessy, Megan, Smolskis, Mary C., Touloumi, Giota, Wright, Mary E., Doyle, Mittie K., Popik, Sharon, Hall, Christine, Ramanathan, Roshan, Cao, Huyen, Mondou, Elsa, Willis, Todd, Thakuria, Joseph V., Yel, Leman, Higgs, Elizabeth, Kan, Virginia L., Lundgren, Jens D., Neaton, James D., and Lane, H. Clifford
- Published
- 2022
- Full Text
- View/download PDF
9. Strategy management in collaborative clinical research partnerships
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Kagan, Jonathan, Lassa, Jerome, Zuckerman, Judith, Cull, Ellen, Boan, David, Lysander, Julia, Njoh, Wissedi, Johnson, Kumblytee, Sardana, Ratna, Stern, Kaytee, Grace, Beth, McNay, Laura, and Tegli, Jemee
- Published
- 2021
- Full Text
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10. PREVAIL I Cluster Vaccination Study With rVSVΔ-GZEBOV-GP as Part of a Public Health Response in Liberia
- Author
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Bolay, Fatorma K., Grandits, Greg, Lane, H. Clifford, Kennedy, Stephen B., Johnson, Melvin P., Fallah, Mosoka P., Wilson, Barthalomew, Njoh, Wissedi S., McNay, Laura A., Hensley, Lisa E., and Higgs, Elizabeth S.
- Published
- 2019
11. A review of strategies used to retain participants in clinical research during an infectious disease outbreak: The PREVAIL I Ebola vaccine trial experience
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Browne, Sarah, Carter, Tarweh, Eckes, Risa, Grandits, Greg, Johnson, Melvin, Moore, Irene, and McNay, Laura
- Published
- 2018
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12. Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial
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Sabik, Lindsay, Pace, Christine A., Forster-Gertner, Heidi P., Wendler, David, Bebchuk, Judith D., Tavel, Jorge A., McNay, Laura A., Killen, Jack, Emanuel, Ezekiel J., and Grady, Christine
- Published
- 2005
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13. The Quality of Informed Consent in a Clinical Research Study in Thailand
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Pace, Christine, Emanuel, Ezekiel J., Chuenyam, Theshinee, Duncombe, Chris, Bebchuk, Judith D., Wendler, David, Tavel, Jorge A., McNay, Laura A., Phanuphak, Praphan, Forster, Heidi P., and Grady, Christine
- Published
- 2005
- Full Text
- View/download PDF
14. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial
- Author
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Brown, Samuel M, primary, Barkauskas, Christina E, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Phillips, Andrew N, additional, Leither, Lindsay, additional, Peltan, Ithan D, additional, Lanspa, Michael, additional, Gilstrap, Daniel L, additional, Mourad, Ahmad, additional, Lane, Kathleen, additional, Beitler, Jeremy R, additional, Serra, Alexis L, additional, Garcia, Ivan, additional, Almasri, Eyad, additional, Fayed, Mohamed, additional, Hubel, Kinsley, additional, Harris, Estelle S, additional, Middleton, Elizabeth A, additional, Barrios, Macy A G, additional, Mathews, Kusum S, additional, Goel, Neha N, additional, Acquah, Samuel, additional, Mosier, Jarrod, additional, Hypes, Cameron, additional, Salvagio Campbell, Elizabeth, additional, Khan, Akram, additional, Hough, Catherine L, additional, Wilson, Jennifer G, additional, Levitt, Joseph E, additional, Duggal, Abhijit, additional, Dugar, Siddharth, additional, Goodwin, Andrew J, additional, Terry, Charles, additional, Chen, Peter, additional, Torbati, Sam, additional, Iyer, Nithya, additional, Sandkovsky, Uriel S, additional, Johnson, Nicholas J, additional, Robinson, Bryce R H, additional, Matthay, Michael A, additional, Aggarwal, Neil R, additional, Douglas, Ivor S, additional, Casey, Jonathan D, additional, Hache-Marliere, Manuel, additional, Georges Youssef, J, additional, Nkemdirim, William, additional, Leshnower, Brad, additional, Awan, Omar, additional, Pannu, Sonal, additional, O'Mahony, Darragh Shane, additional, Manian, Prasad, additional, Awori Hayanga, J W, additional, Wortmann, Glenn W, additional, Tomazini, Bruno M, additional, Miller, Robert F, additional, Jensen, Jens-Ulrik, additional, Murray, Daniel D, additional, Bickell, Nina A, additional, Zatakia, Jigna, additional, Burris, Sarah, additional, Higgs, Elizabeth S, additional, Natarajan, Ven, additional, Dewar, Robin L, additional, Schechner, Adam, additional, Kang, Nayon, additional, Arenas-Pinto, Alejandro, additional, Hudson, Fleur, additional, Ginde, Adit A, additional, Self, Wesley H, additional, Rogers, Angela J, additional, Oldmixon, Cathryn F, additional, Morin, Haley, additional, Sanchez, Adriana, additional, Weintrob, Amy C, additional, Cavalcanti, Alexandre Biasi, additional, Davis-Karim, Anne, additional, Engen, Nicole, additional, Denning, Eileen, additional, Taylor Thompson, B, additional, Gelijns, Annetine C, additional, Kan, Virginia, additional, Davey, Victoria J, additional, Lundgren, Jens D, additional, Babiker, Abdel G, additional, Neaton, James D, additional, Lane, H Clifford, additional, Tierney, John, additional, Vogel, Susan E., additional, McNay, Laura A., additional, Cahill, Kelly, additional, Crew, Page, additional, Sardana, Ratna, additional, Segal Raim, Sharo, additional, Shaw-Saliba, Katy, additional, Atri, Negin, additional, Miller, Mark, additional, Vallee, David, additional, Chung, Lucy, additional, Delph, Yvette, additional, Adam, Stacey J., additional, Read, Sarah, additional, Draghia-Akli, Ruxandra, additional, Harrigan, Rachel, additional, Carlsen, Amy, additional, Carter, Anita, additional, DuChene, Alain, additional, Eckroth, Kate, additional, Frase, Alex, additional, Harrison, Merrie, additional, Meger, Sue, additional, Quan, Kien, additional, Quan, Siu Fun, additional, Reilly, Cavan, additional, Thompson, Greg, additional, Walski, Jamie, additional, Moskowitz, Alan J., additional, Bagiella, Emilia, additional, Moquete, Ellen, additional, O'Sullivan, Karen, additional, Marks, Mary E., additional, Accardi, Evan, additional, Kinzel, Emily, additional, Bedoya, Gabriela, additional, Gupta, Lopa, additional, Overbey, Jessica R., additional, Padillia, Maria L., additional, Santos, Milerva, additional, Gillinov, Marc A., additional, Miller, Marissa A., additional, Taddei-Peters, Wendy C., additional, Fenton, Kathleen, additional, Smith, Peter K., additional, Vekstein, Andrew M., additional, Ko, Emily R., additional, Al-Hegelan, Mashael S., additional, McGowan, Lauren M., additional, Motta, Mary, additional, Howell, Shauna, additional, Bent, Francine, additional, Kalager, Rachel, additional, Chan, Emmanuel, additional, Aloor, Heather L., additional, Griffin, S. Michelle, additional, Covington, Anna, additional, McLendon-Arvik, Beth, additional, Bussadori, Barbara, additional, Miller-Bell, Mary, additional, Sampey, Cathy, additional, Gaver, Vincent, additional, Hollister, Beth A., additional, Giangiacomo, Dana M., additional, Pauley, Alena, additional, Patel, Aashay, additional, Classon, Chris, additional, Frazier, Madison, additional, Osborne, Robyn, additional, Conlon, Debbi H., additional, Joshi, Marybeth, additional, Gottlieb, Robert L., additional, Mack, Michael, additional, Berhe, Mezgebe, additional, Haley, Clinton, additional, Dishner, Emma, additional, Bettacchi, Christopher, additional, Golden, Kevin, additional, Duhaime, Erin, additional, Ryan, Madison, additional, Tallmadge, Catherine, additional, Estrada, Lorie, additional, Jones, Felecia, additional, Villa, Samantha, additional, Wang, Samantha, additional, Robert, Raven, additional, Coleman, Tanquinisha, additional, Clariday, Laura, additional, Baker, Rebecca, additional, Hurutado-Rodriguez, Mariana, additional, Iram, Nazia, additional, Fresnedo, Michelle, additional, Davis, Allyson, additional, Leonard, Kiara, additional, Ramierez, Noelia, additional, Thammavong, Jon, additional, Duque, Krizia, additional, Turner, Emma, additional, Fisher, Tammy, additional, Robinson, Dianna, additional, Ransom, Desirae, additional, Maldonado, Nicholas, additional, Lusk, Erica, additional, Killian, Aaron, additional, Palacios, Adriana, additional, Solis, Edilia, additional, Jerrow, Janet, additional, Watts, Matthew, additional, Whitacre, Heather, additional, Cothran, Elizabeth, additional, Bender, William, additional, Miller, Jeffrey, additional, Nugent, Katherine, additional, Farrington, Woodrow, additional, Baio, Kim T., additional, McBride, Mary K., additional, Fielding, Michele, additional, Mathewson, Sonya, additional, Porte, Kristina, additional, Haley, Elizabeth, additional, Rogers, Susan, additional, Tyler, Derrick, additional, Perin, Emerson, additional, Costello, Briana, additional, Postalian, Alexander, additional, Sohail, Rizwan, additional, Hinsu, Punit, additional, Watson, Carolyn, additional, Kappenman, Casey, additional, Chen, James, additional, Walker, Kim, additional, Fink, Melyssa, additional, Phillip, Gabrielle, additional, Mahon, Kim, additional, Sturgis, Lydia, additional, Maher, Patrick, additional, Rogers, Linda, additional, Ng, Nicole, additional, Marshall, Jason, additional, Bassily-Marcus, Adel, additional, Cohen, Ivy, additional, Ramoo, Shamini, additional, Malhotra, Aryan, additional, Kessler, Jonathan, additional, Goetz, Rebekah, additional, Badhwar, Vinay, additional, Hayanga, Jeremiah, additional, Giblin Sutton, Lisa, additional, Williams, Roger, additional, Berry Bartolo, Elizabeth, additional, Walker, Dmitry, additional, Bunner, Robin, additional, Glaze, Chad, additional, Aucremanne, Tanja, additional, Bishop, James, additional, Kelley, Macey, additional, Peterson, Autumn, additional, Sauerborn, Erica, additional, Reckart, Robin, additional, Miller, Brittany, additional, Mittel, Aaron, additional, Darmanian, Anita, additional, Rosen, Amanda, additional, Madahar, Purnema, additional, Schicchi, John, additional, Gosek, Katarzyna, additional, Dzierba, Amy, additional, Wahab, Romina, additional, Eng, Connie, additional, Al-Saadi, Mukhtar, additional, Zahiruddin, Faisal, additional, Syed, Mohi, additional, George, Michael, additional, Patel, Varsha, additional, Onwunyi, Chisom, additional, Barroso da Costa, Rosa, additional, North, Crystal, additional, Ringwood, Nancy, additional, Fitzgerald, Laura, additional, Muzikansky, Ariela, additional, Morse, Richard, additional, Brower, Roy G., additional, Reineck, Lora A., additional, Bienstock, Karen, additional, Hou, Peter, additional, Steingrub, Jay S., additional, Tidswell, Mark A., additional, Kozikowski, Lori-Ann, additional, Kardos, Cynthia, additional, De Souza, Leslie, additional, Talmor, Daniel, additional, Shapiro, Nathan, additional, Hibbert, Kathryn, additional, Brait, Kelsey, additional, Kone, Mamary, additional, Hendey, Gregory, additional, Kangelaris, Kirsten N., additional, Ashktorab, Kimia, additional, Gropper, Rachel, additional, Agrawal, Anika, additional, Timothy, Kelly, additional, Zhou, Hanjing, additional, Hughes, Alyssa, additional, Garcia, Rebekah, additional, Torres, Adrian, additional, Hernandez-Almaraz, Maria Elena, additional, Vojnik, Rosemary, additional, Perez, Cynthia, additional, McDowell, Jordan, additional, Chang, Steven Y., additional, Vargas, Julia, additional, Moss, Marc, additional, McKeehan, Jeffrey, additional, Higgins, Carrie, additional, Johnson, Emily, additional, Slaughter, Suzanne, additional, Wyles, David, additional, Hiller, Terra, additional, Oakes, Judy, additional, Garcia, Ana, additional, Gravitz, Stephanie, additional, Lyle, Carolynn, additional, Swanson, Diandra, additional, Gong, Michelle Ng., additional, Richardson, Lynnne D., additional, Chen, Jen-Ting, additional, Moskowitz, Ari, additional, Mohamed, Amira, additional, Lopez, Brenda, additional, Amosu, Omowunmi, additional, Tzehaie, Hiwet, additional, Boujid, Sabah, additional, Bixby, Billie, additional, Lopez, Anitza A., additional, Durley, JaVon, additional, Gilson, Boris, additional, Hite, R. Duncan, additional, Wang, Henry, additional, Wiedemann, Hebert P., additional, Mehkri, Omar, additional, Ashok, Kiran, additional, King, Alexander, additional, Brennan, Connery, additional, Exline, Matthew C., additional, Englert, Joshua A., additional, Karow, Sarah, additional, Schwartz, Elizabeth, additional, So, Preston, additional, So, Madison, additional, Krol, Olivia F., additional, Briceno Parra, Genesis I., additional, Mills, Emmanuel Nii Lantei, additional, Oh, Minn, additional, Pena, Jose, additional, Martínez, Jesús Alejandro, additional, Jackman, Susan E., additional, Bayoumi, Emad, additional, Pascual, Ethan, additional, Caudill, Antonina, additional, Chen, Po-En, additional, Richardson, Tabia, additional, Clapham, Gregg J., additional, Herrera, Lisa, additional, Ojukwu, Cristabelle, additional, Fine, Devin, additional, Gomez, Millie J., additional, Choi-Kuaea, Yunhee, additional, Weissberg, Gwendolyn, additional, Isip, Katherine, additional, Mattison, Brittany, additional, Tran, Dana, additional, Emilov Dukov, Jennifer, additional, Chung, Paul, additional, Kang, Bo Ran, additional, Escobar, Lauren, additional, Tran, Trung, additional, Baig, Saba, additional, Wallick, Julie A., additional, Duven, Alexandria M., additional, Fletcher, Dakota D., additional, Gundel, Stephanie, additional, Fuentes, Megan, additional, Newton, Maranda, additional, Peterson, Emily, additional, Jiang, Kelsey, additional, Files, D. Clark, additional, Miller, Chadwick, additional, Lematty, Caitlin, additional, Rasberry, April, additional, Warden, Ashley, additional, Bledsoe, Joseph, additional, Knowlton, Kirk, additional, Knox, Daniel B., additional, Klippel, Carolyn, additional, Armbruster, Brent P., additional, Applegate, Darrin, additional, Imel, Karah, additional, Fergus, Melissa, additional, Rahmati, Kasra, additional, Jensen, Hannah, additional, Aston, Valerie T., additional, Jeppson, Joshua, additional, Marshall, J. Hunter, additional, Lumpkin, Jenna, additional, Smith, Cassie, additional, Burke, Tyler, additional, Gray, Andrew, additional, Paine, Robert, additional, Callahan, Sean, additional, Yamane, Misty, additional, Waddoups, Lindsey, additional, Rice, Todd W., additional, Johnson, Jakea, additional, Gray, Christopher, additional, Hays, Margaret, additional, Roth, Megan, additional, Musick, Sarah, additional, Miller, Karen, additional, Semler, Matthew W., additional, Popielski, Laura, additional, Kambo, Amy, additional, Viens, Kimberly, additional, Turner, Melissa, additional, Vjecha, Michael J., additional, Denyer, Rachel, additional, Khosla, Rahul, additional, Rajendran, Bindu, additional, Gonzales, Melissa, additional, Moriarty, Theresa, additional, Biswas, Kousick, additional, Harrington, Cristin, additional, Garcia, Amanda, additional, Bremer, Tammy, additional, Burke, Tara, additional, Koker, Brittany, additional, Pittman, David, additional, Vasudeva, Shikha S., additional, Anholm, James D., additional, Specht, Lennard, additional, Rodriguez, Aimee, additional, Ngo, Han, additional, Duong, Lien, additional, Previte, Matthew, additional, Raben, Dorthe, additional, Nielsen, Charlotte B., additional, Friis Larsen, Jakob, additional, Peters, Lars, additional, Matthews, Gail, additional, Kelleher, Anthony, additional, Polizzotto, Mark, additional, Carey, Catherine, additional, Chang, Christina, additional, Dharan, Nila, additional, Hough, Sally, additional, Virachit, Sophie, additional, Davidson, Sarah, additional, Bice, Daniel J., additional, Ognenovska, Katherine, additional, Cabrera, Gesalit, additional, Flynn, Ruth, additional, Abdelghany, Mazin, additional, Baseler, Beth, additional, Teitelbaum, Marc, additional, Holley, H. Preston, additional, Jankelevich, Shirley, additional, Adams, Amy, additional, Becker, Nancy, additional, Doleny, Suzanne, additional, Hissey, Debbie, additional, Simpson, Shelly, additional, Kim, Mi Ha, additional, Beeler, Joy, additional, Harmon, Liam, additional, Vanderpuye, Sharon, additional, Yeon, Lindsey, additional, Frye, Leanna, additional, Rudzinski, Erin, additional, Buehn, Molly, additional, Eccard-Koons, Vanessa, additional, Frary, Sadie, additional, MacDonalad, Leah, additional, Cash, Jennifer, additional, Hoopengardner, Lisa, additional, Linton, Jessica, additional, Nelson, Michaela, additional, Spinelli-Nadzam, Mary, additional, Proffitt, Calvin, additional, Lee, Christopher, additional, Engel, Theresa, additional, Fontaine, Laura, additional, Osborne, CK, additional, Hohn, Matt, additional, Galcik, Michael, additional, Thompson, DeeDee, additional, Sandrus, Jen, additional, Manchard, Jon, additional, Giri, Jiwan, additional, Kopka, Stacy, additional, Chang, Weizhong, additional, Sherman, Brad T., additional, Rupert, Adam W., additional, Highbarger, Helene, additional, Baseler, Michael, additional, Lallemand, Perrine, additional, Rehman, Tauseef, additional, Imamichi, Tom, additional, Laverdure, Sylvain, additional, Paudel, Sharada, additional, Cook, Kyndal, additional, Haupt, Kendra, additional, Hazen, Allison, additional, Badralmaa, Yunden, additional, Highbarger, Jeroen, additional, McCormack, Ashley, additional, Gerry, Norman P., additional, Smith, Kenneth, additional, Patel, Bhakti, additional, Domeraski, Nadia, additional, Hoover, Marie L., additional, DuChateau, Nadine, additional, Flosi, Adam, additional, Nelson, Rich, additional, Stojanovic, Jelena, additional, and Wenner, Christine, additional
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- 2023
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15. Clinical research as a critical component of epidemic response: the case of PREVAIL in Liberia
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Fallah, Mosoka P, primary, Lane, H Clifford, additional, Higgs, Elizabeth S, additional, Kennedy, Stephen B, additional, Massaquoi, Moses B F, additional, Kieh, Mark W S, additional, Neaton, James D, additional, Hensley, Lisa E, additional, McNay, Laura, additional, Njoh, Wissedi, additional, and Doe-Anderson, Jestina, additional
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- 2023
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16. Design of an observational multi-country cohort study to assess immunogenicity of multiple vaccine platforms (InVITE)
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Sereti, Irini, primary, Shaw-Saliba, Kathryn, additional, Dodd, Lori E., additional, Dewar, Robin L., additional, Laverdure, Sylvain, additional, Brown, Shawn, additional, Mbaya, Olivier Tshiani, additional, Muyembe Tamfum, Jean Jacques, additional, Mblala-Kingebeni, Placide, additional, Sow, Ydrissa, additional, Akpa, Esther, additional, Haidara, Mory Cherif, additional, Fouth Tchos, Karine, additional, Beavogui, Abdoul Habib, additional, Neal, Aaron, additional, Arlinda, Dona, additional, Lokida, Dewi, additional, Grue, Louis, additional, Smolskis, Mary, additional, McNay, Laura A., additional, Gayedyu-Dennis, Dehkontee, additional, Ruiz-Palacios, Guillermo M., additional, Montenegro-Liendo, Abelardo, additional, Tounkara, Moctar, additional, Samake, Seydou, additional, Jargalsaikhan, Ganbolor, additional, Zulkhuu, Delgersaikhan, additional, Weyers, Shera, additional, Bonnett, Tyler, additional, Potter, Gail E., additional, Stevens, Randy, additional, Rupert, Adam, additional, Aboulhab, Jamila, additional, Biampata, Jean-Luc, additional, Delamo, Alexandre, additional, Camara, Bienvenu Salim, additional, Kosasih Indonesia, Herman, additional, Karyana, Muhammad, additional, Duworko, James T., additional, Regalado-Pineda, Justino, additional, Guerra-de-Blas, Paola del Carmen, additional, Doumbia, Seydou, additional, Dabitao, Djeneba, additional, Dashdorj, Naranjargal, additional, Dashdorj, Naranbaatar, additional, Newell, Kevin, additional, Francis, Alyson, additional, Rubenstein, Kevin, additional, Bera, Victoria, additional, Gulati, Iman, additional, Sardana, Ratna, additional, Millard, Monica, additional, Ridzon, Renee, additional, and Hunsberger, Sally, additional
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- 2022
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17. Correction: Design of an observational multi-country cohort study to assess immunogenicity of multiple vaccine platforms (InVITE).
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Sereti, Irini, Shaw-Saliba, Kathryn, Dodd, Lori E., Dewar, Robin L., Laverdure, Sylvain, Brown, Shawn, Mbaya, Olivier Tshiani, Muyembe Tamfum, Jean Jacques, Mblala-Kingebeni, Placide, Sow, Ydrissa, Akpa, Esther, Haidara, Mory Cherif, Tchos, Karine Fouth, Beavogui, Abdoul Habib, Neal, Aaron, Arlinda, Dona, Lokida, Dewi, Grue, Louis, Smolskis, Mary, and McNay, Laura A.
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VACCINE immunogenicity ,COHORT analysis ,ORTHOGRAPHY & spelling - Published
- 2024
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18. Community-based hospitals: New partners for government-sponsored clinical research during public health emergencies
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McNay, Laura A., primary, Arnoczy, Gretchen, additional, Martell, Mary, additional, Mock, Polly, additional, Wright, Mary E., additional, Simpson, Shelly, additional, Smolskis, Mary, additional, and Higgs, Elizabeth S., additional
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- 2021
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19. Benchmarking sites: how one clinical research project utilized benchmarks to gauge site performance and compliance
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Simpson, Shelly, Africa, Lorraine, Ledwaba, Lotty, Lessing, Anita, Mphele, Siza, Thomas, Jenny, McNay, Laura, and Zuckerman, Judith
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Medical research -- Methods -- Usage ,Medicine, Experimental -- Methods -- Usage ,Practice guidelines (Medicine) -- Usage -- Methods ,HIV infection -- Diagnosis -- Care and treatment ,General interest ,Health - Abstract
Project Phidisa is a clinical research project focused on the management and treatment of HIV infection in the uniformed members of the South African National Defence Force (SANDF) and their [...]
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- 2008
20. Regulatory approvals in a large multinational clinical trial: the ESPRIT experience
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McNay, Laura A, Tavel, Jorge A, Oseekey, Karen, McDermott, Cathy M, Mollerup, David, Bebchuk, Judith D, and for the ESPRIT Group
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- 2002
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21. PREVAIL I Cluster Vaccination Study With rVSVΔG-ZEBOV-GP as Part of a Public Health Response in Liberia
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Bolay, Fatorma K, primary, Grandits, Greg, additional, Lane, H Clifford, additional, Kennedy, Stephen B, additional, Johnson, Melvin P, additional, Fallah, Mosoka P, additional, Wilson, Barthalomew, additional, Njoh, Wissedi S, additional, McNay, Laura A, additional, Hensley, Lisa E, additional, and Higgs, Elizabeth S, additional
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- 2018
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22. Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency
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Larson, Gregg S., primary, Baseler, Beth R., additional, Hoover, Marie L., additional, Pierson, Jerome F., additional, Tegli, Jemee K., additional, Johnson, Melvin P., additional, Kieh, Mark W. S., additional, McNay, Laura A., additional, and Njoh, Wissedi Sio, additional
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- 2017
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23. PREVAIL I Cluster Vaccination Study With rVSVΔG-ZEBOV-GP as Part of a Public Health Response in Liberia.
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Bolay, Fatorma K, Grandits, Greg, Lane, H Clifford, Kennedy, Stephen B, Johnson, Melvin P, Fallah, Mosoka P, Wilson, Barthalomew, Njoh, Wissedi S, McNay, Laura A, Hensley, Lisa E, and Higgs, Elizabeth S
- Subjects
EBOLA virus disease ,VACCINATION ,PUBLIC health ,ANTIBODY formation ,EBOLA virus disease prevention ,PREVENTION of epidemics ,CLINICAL trials ,COMPARATIVE studies ,IMMUNIZATION ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,VIRAL vaccines ,EVALUATION research ,CONTACT tracing ,EBOLA virus - Abstract
Objective: In November 2015, a 15-year-old boy received a diagnosis of Ebola virus disease (EVD) at the John F. Kennedy Medical Center in Monrovia, Liberia. Two additional family members received a diagnosis of EVD. The protocol for a phase 2 placebo-controlled trial of 2 Ebola vaccines was amended and approved; in 4 days, a single-arm cluster vaccination trial using the Merck rVSVΔG-ZEBOV-GP vaccine was initiated. Here, we evaluate the safety and immunogenicity of the vaccine and discuss challenges for its implementation in a small Ebola outbreak.Method: We conducted a ring vaccination study among contacts and contacts of close contacts of EVD cases a in Monrovia. Participants were evaluated 1 and 6 months after vaccination.Results: Among 650 close contacts and contacts of close contacts of EVD cases, 210 (32%) consented and were vaccinated with rVSVΔG-ZEBOV-GP. Of those vaccinated, 189 (90%) attended the month 1 follow-up visit; 166 (79%) attended the month 6 visit. No serious adverse events were reported. Among 88 participants without an elevated antibody level at baseline, 77.3% (95% confidence interval, 68.5-86.1) had an antibody response at 1 month.Conclusions: The Merck rVSVΔG-ZEBOV-GP vaccine appeared to be safe and immunogenic among the vaccinated individuals. However, fewer than one third of eligible individuals consented to vaccination. These data may help guide implementation decisions for of cluster vaccination programs in an Ebola cluster outbreak response situation. [ABSTRACT FROM AUTHOR]- Published
- 2019
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24. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial
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Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, Lane, H Clifford, Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, and Wenner, Christine
- Abstract
There is a clinical need for therapeutics for COVID-19 patients with acute hypoxemic respiratory failure whose 60-day mortality remains at 30-50%. Aviptadil, a lung-protective neuropeptide, and remdesivir, a nucleotide prodrug of an adenosine analog, were compared with placebo among patients with COVID-19 acute hypoxaemic respiratory failure.
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- 2024
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- View/download PDF
25. Post-trial Access to Tested Interventions: The Views of IRB/REC Chair, Investigators, and Research Participants in a Multinational HIV/AIDS Study
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Pace, Christine, primary, Grady, Christine, additional, Wendler, David, additional, Bebchuk, Judith D., additional, Tavel, Jorge A., additional, McNay, Laura A., additional, Forster, Heidi P., additional, Killen, Jack, additional, and Emanuel, Ezekiel J., additional
- Published
- 2006
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26. Benchmarking SITES.
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Simpson, Shelly, Africa, Lorraine, Ledwaba, Lotty, Lessing, Anita, Mphele, Siza, Thomas, Jenny, McNay, Laura, and Zuckerman, Judith
- Subjects
BENCHMARKING (Management) ,CLINICAL trials ,HIV infections ,MEDICAL research ,LEGAL compliance - Abstract
The article discusses the significance of benchmarking for Phidisa, a clinical research project on the management and treatment of HIV infection. Benchmarks are a tool for members of the Phidisa Project to prioritize and examine the outcomes of the compliance assessments and to measure any interventions that were enforced to diminish noncompliance. The aims of benchmarking are to improve data quality and increment subject safety. It is projected to give site goals and drive process enhancements.
- Published
- 2008
27. Predictors of CD4 count change over 8 months of follow up in HIV-1-infected patients with a CD4 count >= 300 cells/mu L who were assigned to 7.5 MIU interleukin-2
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Fox, Zoe, Antunes, Francisco, Davey, Rick, Gazzard, Brian, Klimas, Nancy, Labriola, Ann, Losso, Marcelo, Neaton, James D., Phillips, Andrew N., Ruxrungtham, Kiat, Staszewski, Schlomo, Weiss, Laurence, Lundgren, Jens D., Abrams, Donald I., Cooper, David A., Darbyshire, Janet H., Duncan, William R., Emery, Sean, Lane, H. Clifford, Lehrman, Sandra, Aguilar, Liliana, Betina Angel, Eleonora, Aquilia, Silvia, Belloso, Waldo, Benetucci, Jorge, Bittar, Victor, Cahn, Pedro, Casiro, Arnaldo, Contarelli, Jorge, Corral, Jorge, Daciuk, Lucia, David, Daniel, Ferrari, Ines, Fridman, Diego, Galache, Viviana, Guaragna, Graciela, Ivalo, Silvina, Laplume, Hector, Lanusse, Isabel, Lasala, Maria B., Lattes, Roberta, Lasovsky, Jaime, Lopardo, Gustavo, Lourtau, Leonardo, Lupo, Sergio, Maranzana, Aldo, Marson, Cristina, Massera, Lucila, Del Lujan Sanchez, Marisa, Somenzini, Carla, Tocci, Mariel, Algar, Sally, Anderson, Jonathan, Baker, David, Blavius, Kathy, Bloch, Mark, Boyle, Michael, Bradford, David, Britton, Phillip, Carrall, Leah, Carr, Andrew, Chuah, John, Curry, Michael, D Arcy-Evans, Clive, Dobson, Pauline, Doong, Nicholas, Egan, Cari, Ferguson, Wendy, Finlayson, Robert, French, Martyn, Frater, Anthony, Gold, Julian, Habel, Philip, Haig, Kay, Holland, Rohan, Hyland, Natalie, Hoy, Jennifer, Hudson, Jeff, James, Robyn, Leung, Jenny, Lowe, Kaye, Macrae, Karen, Mcmurchie, Marilyn, Medland, Nicholas, Miller, Samantha, Murray, Jo, Newman, Rosie, Orth, David, Patching, Julie, Primrose, Ruth, Ree, Hugo, Richardson, Robyn, Rogers, Gary, Roney, Janine, Roth, Norman, Sarangapany, Jeganathan, Shaw, David, Silberberg, Carol, Skett, Jenny, Williams, Leah, Soo, Tuck Meng, Sowden, David, Street, Alan, Vale, Robyn, Villella, Claudio, Walker, Alan, Watson, Ashley, Wendt, Ngaire, Wood, Helen, Youds, David, Aichelburg, Alexander, Rieger, Armin, Vetter, Norbert, Clumeck, Nathan, Wit, Stephane, Kabeya, Kabamba, O Doherty, Elizabeth, Amorim, Cristiane Sales, Basso, Caritas Relva, Lewi, David Salamao, Pereira, Luiz Carlos, Da Silva, Mariliza, Lobato Souza, Tamara Newman, Angel, Jonathan, Bouchard, Pierrette-Rolande, Clark, Fran, Cohen, Jeff, Dambreville, Mimose, Ellis, Michele, Fiset, Stephan, Foster, Andrea, Fraser, Christopher, Gagnon, Susan, Gilmour, Janet, Guenette, Richard, Haldane, Heather, Hawley-Foss, Nanci, Hyndman, Susan, Johnston, Lynn, Jubinville, Nathalie, Juneau, Francoise, Kelleher, Lynn, Lapointe, Lyne, Latendre-Paquette, Judy, Lindemulder, Adeline, Mashinter, Laura, Lefebvre, Eric, Mcfarland, Nancy, Morisseau, Chantal, O Neill, Robert, Piche, Alain, Ralph, Edward, Rouleau, Danielle, Routy, Jean-Pierre, Sandre, Roger, Schmidt, Shelley, Shafran, Stephen, Smaill, Fiona, Stromberg, Dale, Trepanier, Jean-Marc, Trottier, Sylvie, Veal, Susanne, Walmsley, Sharon, Weiss, Karl, Williams, Kurt, Young, Mavis, Zaleschuk, Barbara, Zarowny, Don, Baadegaard, Bente, Black, Finn, Boedker, Kirsten, Gerstoft, Jan, Jensen, Lene, Mathiesen, Lars, Nielsen, Henrik, Pedersen, Court, Petersen, Dorthe, Aboulker, Jean-Pierre, Baakili, Adyb, Bengrait, Nafissa, Bensalem, Maryse, Berthe, Huguette, Bloche, Martin, Bazin, Claude, Boue, Francois, Bouvet, Elisabeth, Brancon, Christiane, Capitant, Catherine, Ceppi, Carole, Cheneau, Christine, Coutellier, Anne, Chennebault, Jean Marie, Coquet, Fabienne, Truchis, Pierre, Delavalle, Anne-Marie, Frixon-Marin, Veronique, Gastaut, Jean-Albert, Delfraissy, Francois, Eliaszeicz, Muriel, Gallais, Herve, Gataut, Jean-Albert, Gilquin, Jacques, Gonzalez-Canali, Gustavo, Gaudebout, Chrisiane, Goujard, Cecile, Hoen, Bruno, Honore, Patricia, Jarousse, Bernard, Lang, Jean-Marie, Lefebvre, Benedict, Levy, Yves, Loison, Jocelyne, Maignan, Aline, Meynard, Jean-Luc, Michon, Christophe, Mole, Martin, Marsal, Laurence, Matheron, Sophie, Mortier, Emmanuel, Oksenhendler, Eric, Poirier, Sandrine, Picard-Dahan, Catherine, Ravaux, Isabelle, Raffi, Francois, Raguin, Gilles, Reynes, Jacque, Rozenbaum, Willy, Salmon, Dominique, Simon, Anne, Spiridon, Gabriella, Viard, Jean-Paul, Vidal, Michele, Zucman, David, Bergmann, Frank, Brockmeyer, Norbert, Faetkenheuer, Gerd, Fenske, Stefan, Gey, Daniela, Goebel, Frank-Detlef, Goetsch, Martina, Hartmann, Martin, Klinker, Hartwig, Kremer, Gisela, Mantzsch, Kathleen, Mauss, Stefan, Rockstroh, Juergen, Rotty, Jessica, Rund, Ellen, Schneider, Katrin, Schuermann, Dirk, Staszweski, Schlomo, Tilmann, Klaus, Vogel, Martin, Bentwich, Zvi, Drora, Goldstain, Kedem, Eynat, Lang, Ruth, Levi, Itzic, Maayan, Shlomo, Magen, Eli, Mamorsky, Merav, Pilpul, Anat, Pollack, Shimon, Sthoeger, Zev, Vered, Hadas, Yust, Israel, Lyons, Fiona, Mulcahy, Fiona, Rochford, Annette, Auiti, Fernando, Angarano, Gioacchino, Bertelli, Davide, Bini, Teresa, Bruno, Raffaele, Cadeo, Gian Pietro, Carosi, Giampietro, D Arminio Monforte, Antonella, Del Giacco, Sergio, Di Pietro, Massimo, Esposito, Roberto, Filice, Gaetano, Gavazzeni, Gabriella, Guaraldi, Giovanni, Indiveri, Francesco, Lazzarin, Adriano, Mazzotta, Francesco, Minolli, Lorenzo, Montroni, Maria, Moroni, Mauro, Nozza, Silvia, Pastor, Guiseppe, Poli, Guido, Raise, Enzo, Romagnani, Sergio, Rusconi, Vega, Sacchi, Paolo, Suter, Fredy, Tambussi, Giuseppe, Tirelli, Umberto, Fraser, Helen, Iwamoto, Aikichi, Kikuchi, Yoshida, Mori, Masahiko, Nakamura, Tetsuya, Odawara, Takashi, Oka, Shinichi, Shirasaka, Takuma, Takano, Misao, To, Junichiro, Ueta, Chisato, El Filali, Kamal, Erradey, Ikbale, Himmich, Hakima, Blok, W., Borleffs, J., Bravenboer, B., Bronveld, W., Claessen, F., Duurvoort, Maurice, Ferwerda, J., Frissen, P., Hulshoff, Nicolette, Juttman, Job, Kauffmann, R., Koopmans, P., Kroon, F., Lowe, Selwyn, Leemhuis, M., Meenhorst, P., Boer, Lieselotte Posthuma, Reiss, Peter, Reinders-Folmer, S., Richter, C., Santegoets, Rick, Schoemaker, Marijke, Schrey, G., Sprenger, Herman, Ten Veen, Jacob, Tessalaar, Judith, Ende, M., Vall, H., Eeden, Arne, Leeuwen, Remko, Vermeulen, Joost, Ten Kate, Reinier W., Boxtel, Renee, Eden, Arne, Ven, Bernadette, Meulen, Piet, Ten Napei, C., Vriesendrop, R., Bruun, Johann, Bakowska, Elzbieta, Beniowski, Marek, Boron-Kaczmarska, Anna, Gasiorowski, Jacek, Gxadysz, Andrzej, Horban, Andrzej, Knysz, Brygida, Mularska, Elzbieta, Pynka, Magdelena, Szymczak, Aleksandra, Aldir, Isabel, Doroana, Manuela, Duque, Luis, Mansinho, Kamal, Pinto, Inez, Valadas, Emilia, Vera, Jose, Foo, Estelle, Panchalingham, Anushia, Lim, Poh Lian, Paton, Nick, Peperstraete, Bernard, Quek, Angela, Alcazar-Caballero, Rosario, Arrizabalaga, Julio, Bouza, Emilio, Cepeda, Concepcion, Barron, Xabier, Cervero Jimenez, Miguel, Clotet, Bonaventura, Cortes, Luis, Domingo, Pere, Fernandez, Pompeyo, Fernandez-Cruz, Eduardo, Fuster, Montserrat, Gatell, Jose, Gijon, Paloma, Gil, Ignacio, Gonzales-Lahoz, Juan, Gonzalez, Alicia, Hernandez, Manuel, Iribarren, Jose, Jimenez, Miguel, Knobel, Hernando, Leon, Agathe, Carlos Lopez, Juan, Lozano, Angeles, Lopez, Paco, Moreno, Jose, Munoz, Rosa, Padilla, Belen, Parras, Angeles, Pastor, Antoni, Pedreira, Jose, Pristo, Julio, Pena, Jose, Roca, Victor, Rubio, Rafael, Sanchez Rivera, Jose, Sanz, Jesus, Tamargo, Lara, Torres, Rafael, Pehrson, Pehr O., Sandstrom, Eric, Bernasconi, Enos, Gurtner, Vanina, Magenta, Lorenzo, Ampunpong, Uangarun, Bowonwatnuwong, Chureeratana, Chanchai, Patimoaporn, Chetchotisakd, Ploenchan, Chuenyam, Thesinee, Duncombe, Chris, Horsakulthai, Mannassinee, Kantipong, Pacharee, Liddy, John, Phanuphak, Praphan, Pongsurachet, Vithaya, Seekaew, Samroeng, Sonjai, Areerat, Subsri, Nuramon, Suwanagool, Surapol, Techasathit, Wichai, Wankoon, Jaturaporn, Adebiyi, Aderonke, Aldam, Diana, Alexander, Ian, Angus, Brian, Barber, Tristan, Bonnington, Sue, Care, Chris, Carroll, Anne, Cornforth, David, Donaldson, Oscar, Druiff, Laurance, Easterbrook, Philippa, Edwards, Beverley, Ellis, Chris, Fisher, Martin, Fox, Ray, Harrison, Allan, Herman, Sandra, Heald, Lisa, Higgs, Christopher, Jendrulek, Isabelle, Johnson, Margaret, Judges, Lucy, Karim, Fatimah, Kinghorn, George, Laurenti, Julie, Lee, Christine, Leen, Clifford, Legg, Ken, Maw, Raymond, Macconachie, Alisdair, Mckernan, Sinead, Mclean, Lorna, Mcmillan, Andrew, Mguni, Sifiso, Morris, Sheila, Mulchay, Fiona, Mullan, Dee, Mullaney, Scott, Murphy, Maurice, Nunn, Andrew, Ong, Edmund, Owen, Maxine, Palfreeman, Adrian, Perry, Nicky, Peters, Barry, Pozniak, Anton, Ronan, Agnes, Skinner, Cecilia, Stroud, Carol, Takawira, Martin, Tamm, Norbert, Thomas, Rachel, Yee, Thynn Thynn, Vanthuyne, An, Wansborough-Jones, Mark, Weber, Jonathan, White, David, Wilkins, Ed, Wiselka, Martin, Williams, Ian, Waugh, Mike, Wotherspoon, Joyce, Youle, Mike, Doyle, Margaret, Goodwin, Edward, Luskin-Hawk, Roberta, Sullivan, James, Verheggen, Rita, Abrams, Donald, Baxter, John, Besch, C. Lynn, Child, Carroll, Cohn, David, Cooper, Pam, El-Sadr, Wafaa, Farrough, Martha, Fisher, Evelyn, Fuentes, Luis, Gordin, Fred, Graeber, Carol, Kelly, Mary Ellen, Kostman, Jay, Lattanzi, Kelly, Macarthur, Rodger, Makohon, Linda, Markowitz, Norman P., Martinez, Norma, Mastro-Polak, Diane, Mitchell, Vinnie, Mushatt, David, Patterson, Kathryn, Perez, George, Rosmarin, Corey, Rouff, Jack R., Saldanha, Jennifer, Sampson, James, Sawyer, Robert, Standridge, Barbara, Sweeton, Bentley, Tedaldi, Ellen, Thompson, Melanie, Valencia, Patricia, Verlinghieri, Gwen, Walker, Janice, Watson, Vicky, Williams, Bruce, Armstrong, Adam, Banks, Susan, Blazes, David, Barile, Anthony, Coelho, Linda, Dennis, Marilyn, Flaks, Hannah, Gilcrest, Joyce, Gittens, Kathleen, Hopper, Shelia, Humphries, M. J., Spooner, Katherine, Tamminga, Cindy L., Vita, Jean, Wegner, Scott A., Wortmann, Glenn, Bisby, Nicole, Blake, William, Brown, Sheldon, Chilliade, Phillippe, Cole, Teresa, Elliot, Katherine, Geisler, Christiane, Goetz, Matthew, Gomez-Perez, Elizabeth, Helman, Jami, Nahass, Ronald, Leflore, Dirk, Marston, Barbara, Obregon, Maria, Petrolati, Jennifer, Pitrak, David L., Roland, Robert, Rosa, Carol, Rossman, Barbara, Schlueter Wirtz, Susan, Schuck, Suzanne, Scretchings, Tiffany, Simon, Gary, Smith, Mack, Summers, Kimberley, Werhane, Mary Jo, Arduino, Roberto, Bell, Brian, Breaux, Katherine, Cuervo, Hilda, Hale, Carl, Lewis, Stanley, Mall, Mark, Mora, Fransisco, Diez, Martine M., Okhuysen, Pablo, Rodriguez-Barradas, Maria, Schrader, Shannon R., Healy, Lynn, Kaszubski, Chris, Kolber, Michael, Tanner, Tom, Armstrong, Joann, Dahlke, Jennifer, Johnson, Leonard, Kaminski, Patricia, Rhame, Frank, Shoden, Cheryl, Temesgen, Zelalem, Urbanich, Marcy, Valenti, Sharon, Zervos, Marcus, Barrick, Bill, Chaitt, Doreen, Hahn, Barbara, Lane, Cliff, Martell, Dennis, Mcnay, Laura, Metcalf, Julia, Powers, April, Tavel, Jorge A., Loveless, Karen, Peterson, Sue, Sweek, Suzanne, Albrecht, Helmut, Antoine, Nicole, Pell, Paula, Gatell, Jose Maria, Hoy, Jenny, Lifson, Alan, Pederson, Court, Borup, Liselotte, Dragsted, Ulrik Bak, Greve, Anne Fau, Jensen, Karoline, Jens Lundgren, Mollerup, David, Pearson, Mary, Phillips, Andrew, Aboulhab, Jamila, Babiker, Abdel, Cordwell, Brooke, Darbyshire, Janet, Hack, Lisa, Hooker, Malcolm, Moraes, Yolanda, Newberry, Douglas, Nuwagaba-Biribonwoha, Harriet, Hooff, Fionna, Denning, Eileen, Holland Klemme, Leslie, Carey, Cate, Chan, Fonnie, Cooper, David, Courtney-Rodgers, David, Drummond, Fraser, Jacoby, Simone, Law, Matthew, Stewart, Morgan, Pett, Sarah, Alloo, Zarina, Bebchuk, Judy, Bollenbeck, Patty, Duchene, Alain G., Fosdick, Lisa, Harrison, Merrie, Krum, Eric, Larson, Gregg, Meger, Sue, Neaton, James, Nelson, Ray, Quan, Siu-Fun L., Schultz, Terri, Telke, Susan, Thackeray, Lisa, Thompson, Greg, Wentworth, Deborah, Wyman, Nicole, Duncan, William, Ferguson, Elaine, Fox, Lawrence, Gettinger, Nikki, Herrera, Janet, Luzar, Mary Anne, Maeshiro, Mieko, Martinez, Ana, Oseekey, Karen, Baigent, Greg, Capra, William, Duliege, Anne-Marie, Fitzgerald, Linda, Kwakkelstein, Marthin, Maral, Jean, O Hara, Mary, Sahner, David, Weber, Claire, Adam-Perchec, Christine, Barron, Nigel, Bell, Mary Louise, Dolan, Sandra, Eckstrand, Julie, Hicks, Steven, Mcauley, George, Beck, Sharon, Brown, Shawn, and Rupert, Adam
28. 42 Locally Hired Staff for Clinical Research Sites in Low-Resource Settings
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Baseler, Beth, Smolskis, Mary, Doe-Anderson, Jestina, Johnson, Melvin, Njoh, Wissedi, Albert, Sara, Worthington, Chris, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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29. 41 Management of Security for Clinical Trials During Emergencies
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Muyisa, Billy Sivahera, de Sainte Fare, Eric Barte, Aboulhab, Jamila, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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30. 38 Pharmaceutical Management
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Kirchoff, Matthew Carl, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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31. 40.1 In Practice: Improving Patient Care in the Field: The CUBE Isolation Unit
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Kojan, Richard, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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32. 39 Cold Chain and Electrical Power for Emergency Research Response
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Littlefield, Daniel J., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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33. 37 Supply and Logistics for Clinical Research in Low-Resource Settings
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Baseler, Beth, Proffitt, Calvin, Sandrus, Jen, Marchand, Jonathan, Stavale, Eric, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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34. 40 Selecting and Opening a Clinical Research Site in a Low-Resource Setting
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Mbaya, Olivier Tshiani, Njoh, Wissedi, Barrett, Kevin, Smolskis, Mary, Miranda, Alejandra, Gettinger, Nikki, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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35. 35 Data Management in Emergency Response Research
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van Loen, Harry, Badio, Moses, Van Herrewege, Yven, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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36. 34 Information and Communications Technology to Support Research in Low-Resource Settings
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Galcik, Mike, Parrish, David, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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37. 36 Safety and Pharmacovigilance in Emergency Research Response
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Teitelbaum, Marc, Atri, Negin, Cahill, Kelly, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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38. 33.3 In Practice: Capacity Building for Research Ethics Review in Low- and Middle-Income Countries
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Sina, Barbara, Tierney, John, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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39. 33.2 In Practice: Independent Monitoring of Emergency Response Clinical Trials
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Vogel, Susan, Pierson, Jerome F., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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40. 32.2 In Focus: Clinical Trial Insurance and Indemnification
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Larson, Gregg, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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41. 33.1 In Practice: Ethical Review During Emergencies: The Liberian Experience
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Bolay, Fatorma, Sorenson, Robert A., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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42. 32.1 Case Study: Clinical Research Communications during an Outbreak: Media Outreach Supporting Liberia–U.S. Research Partnership
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Kiawu, Hassan, Doepel, Laurie K., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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43. 33 Ethical Review of Clinical Research During an Emergency Response
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Pierson, Jerome F., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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44. 30 Organizational Partnerships for Preparedness and Response to Emerging and Re-emerging Infectious Diseases
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Yazdanpanah, Yazdan, Madelaine, Claire, Pulik, Nicolas, Souteyrand, Yves, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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45. 30.2 In Practice: Building and Maintaining Preparedness for a Rapid Research Response in Indonesia
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Lau, Chuen-Yen, Grue, Louis, Neal, Aaron, Karyana, Muhammad, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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46. 29 International Collaboration to Advance Research Preparedness and Response
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Rojek, Amanda, Carson, Gail, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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47. 26 Social Science Evidence for Outbreak and Pandemic Response: Rapid Research and Analytics for Public Health Emergencies
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Gobat, Nina, Carter, Simone, Kutalek, Ruth, Rashid, Sabina Faiz, Lees, Shelley, Anoko, Julienne Ngoundoung, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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48. 23.1 In Practice: Monitoring the PALM Ebola Therapeutics Study in the Democratic Republic of the Congo
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Proschan, Michael A., DeMets, David L., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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49. 28 Financing Emergency Research Response During Infectious Disease Outbreaks: Lessons from the World Bank and Other International Financial Institutions
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Pate, Muhammad Ali, Bali, Sulzhan, Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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50. 25 Models in the COVID-19 Pandemic
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Imai, Natsuko, Baguelin, Marc, Ferguson, Neil M., Sorenson, Robert A., editor, Higgs, Elizabeth S., Editor-in-Chief, Fallah, Mosoka P., Section Editor, Lurie, Nicole, Section Editor, McNay, Laura A., Section Editor, and Smith, Peter G., Section Editor
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- 2024
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