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Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial
Authors :
Pogorzelski, David Nguyen, Uyen McKay, Paula Thabane, Lehana Camara, Megan Ramsey, Lolita Seymour, Rachel Goodman, J. Brett McGee, Sheketha Fraifogl, Joanne Hudgins, Andrea Tanner, Stephanie L. Bhandari, Mohit Slobogean, Gerard P. Sprague, Sheila Slobogean, Gerard P. Sprague, Sheila Wells, Jeffrey Bhandari, Mohit Slobogean, Gerard P. Bhandari, Mohit Sprague, Sheila D'Alleyrand, Jean-Claude Harris, Anthony D. Mullins, Daniel C. Thabane, Lehana Wells, Jeffrey Wood, Amber Della Rocca, Gregory J. Harris, Anthony D. Hebden, Joan Jeray, Kyle J. Marchand, Lucas O'Hara, Lyndsay M. Zura, Robert Gardner, Michael J. Blasman, Jenna Davies, Jonah Liang, Stephen Taljaard, Monica Devereaux, P.J. Guyatt, Gordon H. Thabane, Lehana Heels-Ansdell, Diane Marvel, Debra Palmer, Jana Wells, Jeffrey Friedrich, Jeff Mullins, Daniel C. O'Hara, Nathan N. Grissom, Ms. Frances Della Rocca, Gregory J. Gitajn, I. Leah Jeray, Kyle J. Morshed, Saam O'Toole, Robert V. Petrisor, Bradley A. Camara, Megan Mossuto, Franca Harris, Anthony D. Joshi, Manjari G. D'Alleyrand, Jean-Claude Fowler, Justin Rivera, Jessica Talbot, Max Sprague, Sheila Bhandari, Mohit Dodds, Shannon Garibaldi, Alisha Li, Silvia Nguyen, Uyen Pogorzelski, David Rojas, Alejandra Scott, Taryn Del Fabbro, Gina Szasz, Olivia Paige Heels-Ansdell, Diane McKay, Paula Slobogean, Gerard P. O'Hara, Nathan N. Howe, Andrea Rudnicki, Joshua Demyanovich, Haley Little, Kelly Mullins, C. Daniel Medeiros, Michelle Kettering, Eric Hale, Diamond O'Toole, Robert V. D'Alleyrand, Jean-Claude Eglseder, Andrew Johnson, Aaron Langhammer, Christopher Lebrun, Christopher Manson, Theodore Nascone, Jason Paryavi, Ebrahim Pensy, Raymond Pollak, Andrew Sciadini, Marcus Slobogean, Gerard P. Degani, Yasmin Demyanovich, Haley K. Howe, Andrea O'Hara, Nathan N. Joseph, Katherine Rudnicki, Joshua Camara, Megan Petrisor, Brad A. Johal, Herman Ristevski, Bill Williams, Dale Denkers, Matthew Rajaratnam, Krishan Al-Asiri, Jamal Leonard, Jordan Marcano-Fernández, Francesc A. Gallant, Jodi Persico, Federico Gjorgjievski, Marko George, Annie Natoli, Roman M. Gaski, Greg E. McKinley, Todd O. Virkus, Walter W. Sorkin, Anthony T. Szatkowski, Jan P. Baele, Joseph R. Mullis, Brian H. Hill, Lauren C. Hudgins, Andrea Osborn, Patrick Fowler, Justin Pierrie, Sarah Martinez, Eric Kimmel, Joseph Jeray, Kyle J. Adams, John D. Beckish, Michael L. Bray, Christopher C. Brown, Timothy R. Cross, Andrew W. Dew, Timothy Faucher, Gregory K. Gurich, Richard W. Lazarus, David E. Millon, S. John Palmer, M. Jason Porter, Scott E. Schaller, Thomas M. Sridhar, Michael S. Sanders, John L. Rudisill, L. Edwin Garitty, Michael J. Poole, Andrew S. Sims, Michael L. Walker, Clark M. Carlisle, Robert M. Hofer, Erin Adams Huggins, Brandon S. Hunter, Michael D. Marshall, William A. Ray, Shea Bielby Smith, Cory D. Altman, Kyle M. Bedard, Julia C. Loeffler, Markus F. Pichiotino, Erin R. Cole, Austin A. Maltz, Ethan J. Parker, Wesley Ramsey, T. Bennett Burnikel, Alex Colello, Michael Stewart, Russell Wise, Jeremy Moody, M. Christian Tanner, Stephanie L. Snider, Rebecca G. Townsend, Christine E. Pham, Kayla H. Martin, Abigail Robertson, Emily Morshed, Saam Miclau, Theodore Kandemir, Utku Marmor, Meir Matityahu, Amir McClellan, R. Trigg Meinberg, Eric Shearer, David Toogood, Paul Ding, Anthony Donohue, Erin Belaye, Tigist Berhaneselase, Eleni Paul, Alexandra Garg, Kartik Gary, Joshua L. Warner, Stephen J. Munz, John W. Choo, Andrew M. Achor, Timothy S. “Chip” Routt, Milton L. Rao, Mayank Pechero, Guillermo Miller, Adam Hagen, Jennifer E. Patrick, Matthew Vlasak, Richard Krupko, Thomas Sadasivan, Kalia Koenig, Chris Bailey, Daniel Wentworth, Daniel Van, Chi Schwartz, Justin Dehghan, Niloofar Jones, Clifford B. Watson, J Tracy McKee, Michael Karim, Ammar Talerico, Michael Sietsema, Debra L. Williams, Alyse Dykes, Tayler Obremskey, William T. Jahangir, Amir Alex Sethi, Manish Boyce, Robert Stinner, Daniel J. Mitchell, Phillip Trochez, Karen Rodriguez, Andres Gajari, Vamshi Rodriguez, Elsa Pritchett, Charles Boulton, Christina Lowe, Jason Wild, Jason Ruth, John T. Taylor, Michel Seach, Andrea Saeed, Sabina Culbert, Hunter Cruz, Alejandro Knapp, Thomas Hurkett, Colin Lowney, Maya Prayson, Michael Venkatarayappa, Indresh Horne, Brandon Jerele, Jennifer Clark, Linda Marcano-Fernández, Francesc Jornet-Gibert, Montsant Martínez-Carreres, Laia Martí-Garín, David Serrano-Sanz, Jorge Sánchez-Fernández, Joel Sanz-Molero, Matsuyama Carballo, Alejandro Pelfort, Xavier Acerboni-Flores, Francesc Alavedra-Massana, Anna Anglada-Torres, Neus Berenguer, Alexandre Cámara-Cabrera, Jaume Caparros-García, Ariadna Fillat-Gomà, Ferran Fuentes-López, Ruben Garcia-Rodriguez, Ramona Gimeno-Calavia, Nuria Graells-Alonso, Guillem Martínez-Álvarez, Marta Martínez-Grau, Patricia Pellejero-García, Raúl Ràfols-Perramon, Ona Peñalver, Juan Manuel Domènech, Mònica Salomó Soler-Cano, Albert Velasco-Barrera, Aldo Yela-Verdú, Christian Bueno-Ruiz, Mercedes Sánchez-Palomino, Estrella Guerra, Ernesto García, Yaiza Romeo, Nicholas M. Vallier, Heather A. Breslin, Mary A. Fraifogl, Joanne Wilson, Eleanor S. Wadenpfuhl, Leanne K. Halliday, Paul G. Viskontas, Darius G. Apostle, Kelly L. Boyer, Dory S. Moola, Farhad O. Perey, Bertrand H. Stone, Trevor B. Lemke, H. Michael Zomar, Mauri Spicer, Ella Fan, Chen “Brenda” Payne, Kyrsten Phelps, Kevin Bosse, Michael Karunakar, Madhav Kempton, Laurence Sims, Stephen Hsu, Joseph Seymour, Rachel Churchill, Christine Bartel, Claire Mayberry, Robert Miles Brownrigg, Maggie Girardi, Cara Mayfield, Ada Hymes, Robert A. Schwartzbach, Cary C. Schulman, Jeff E. Malekzadeh, A. Stephen Holzman, Michael A. Ramsey, Lolita Ahn, James S. Panjshiri, Farhanaz Das, Sharmistha English, Antoinisha D. Haaser, Sharon M. Cuff, Jaslynn A.N. Pilson, Holly Carroll, Eben A. Halvorson, Jason J. Babcock, Sharon Goodman, J. Brett Holden, Martha B. Bullard, Debra Williams, Wendy Higgins, Thomas F. Haller, Justin M. Rothberg, David L. Neese, Ashley Russell, Mark Gitajn, I. Leah Coe, Marcus Dwyer, Kevin Mullin, Devin S. Reilly, Clifford A. DePalo, Peter Hall, Amy E. Heng, Marilyn Harris, Mitchel B. Smith, R. Malcolm Lhowe, David W. Esposito, John G. Bansal, Mira Bergin, Patrick F. Russell, George V. Graves, Matthew L. Morellato, John Champion, Heather K. Johnson, Leslie N. McGee, Sheketha L. Bhanat, Eldrin L. Mehta, Samir Donegan, Derek Ahn, Jaimo Horan, Annamarie Dooley, Mary Kuczinski, Ashley Iwu, Ashley Potter, David VanDemark, Robert Pfaff, Branden Hollinsworth, Troy Weaver, Michael J. von Keudell, Arvind G. McTague, Michael F. Allen, Elizabeth M. Jaeblon, Todd Beer, Robert Demyanovich, Haley K. Gage, Mark J. Reilly, Rachel M. Sparrow, Cindy
Source :
Contemporary Clinical Trials Communications; March 2021, Vol. 21 Issue: 1
Publication Year :
2021
Abstract
Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.
Details
Language :
English
ISSN :
24518654
Volume :
21
Issue :
1
Database :
Supplemental Index
Journal :
Contemporary Clinical Trials Communications
Publication Type :
Periodical
Accession number :
ejs55186271
Full Text :
https://doi.org/10.1016/j.conctc.2021.100730