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28 results on '"Dunn, Imogene"'

1. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial

Author

Consortium, The I-SPY COVID, Files, D Clark, Aggarwal, Neil, Albertson, Timothy, Auld, Sara, Beitler, Jeremy R, Berger, Paul, Burnham, Ellen L, Calfee, Carolyn S, Cobb, Nathan, Crippa, Alessio, Discacciati, Andrea, Eklund, Martin, Esserman, Laura, Friedman, Eliot, Gandotra, Sheetal, Khan, Kashif, Koff, Jonathan, Kumar, Santhi, Liu, Kathleen D, Martin, Thomas R, Matthay, Michael A, Meyer, Nuala J, Obermiller, Timothy, Robinson, Philip, Russell, Derek, Thomas, Karl, Wong, Fum, Wunderink, Richard G, Wurfel, Mark M, Yen, Albert, Youssef, Fady A, Darmanian, Anita, Dzierba, Amy L, Garcia, Ivan, Gosek, Katarzyna, Madahar, Purnema, Mittel, Aaron M, Muir, Justin, Rosen, Amanda, Schicchi, John, Serra, Alexis L, Wahab, Romina, Gibbs, Kevin W, Landreth, Leigha, LaRose, Mary, Parks, Lisa, Wynn, Adina, Ittner, Caroline AG, Mangalmurti, Nilman S, Reilly, John P, Harris, Donna, Methukupally, Abhishek, Patel, Siddharth, Boerger, Lindsie, Kazianis, John, Higgins, Carrie, McKeehan, Jeff, Daniel, Brian, Fields, Scott, Hurst-Hopf, James, Jauregui, Alejandra, Swigart, Lamorna Brown, Blevins, Daniel, Nguyen, Catherine, Suarez, Alexis, Tanios, Maged A, Sarafian, Farjad, Shah, Usman, Adelman, Max, Creel-Bulos, Christina, Detelich, Joshua, Harris, Gavin, Nugent, Katherine, Spainhour, Christina, Yang, Philip, Haczku, Angela, Hardy, Erin, Harper, Richart, Morrissey, Brian, Sandrock, Christian, Budinger, GR Scott, Donnelly, Helen K, Singer, Benjamin D, Moskowitz, Ari, Coleman, Melissa, Levitt, Joseph, Lu, Ruixiao, Henderson, Paul, Asare, Adam, Dunn, Imogene, and Barragan, Alejandro Botello

Subjects
Health Services, Clinical Trials and Supportive Activities, Clinical Research, Good Health and Well Being, I-SPY COVID Consortium, Acute lung injury, Clinical trial, Respiratory insufficiency, SARS-CoV-2
Abstract

BackgroundAn urgent need exists to rapidly screen potential therapeutics for severe COVID-19 or other emerging pathogens associated with high morbidity and mortality.MethodsUsing an adaptive platform design created to rapidly evaluate investigational agents, hospitalised patients with severe COVID-19 requiring ≥6 L/min oxygen were randomised to either a backbone regimen of dexamethasone and remdesivir alone (controls) or backbone plus one open-label investigational agent. Patients were enrolled to the arms described between July 30, 2020 and June 11, 2021 in 20 medical centres in the United States. The platform contained up to four potentially available investigational agents and controls available for randomisation during a single time-period. The two primary endpoints were time-to-recovery (

Published
2023

2. Impact of the hepatoselective glucokinase activator TTP399 on ketoacidosis during insulin withdrawal in people with type 1 diabetes.

Author

Freeman, Jennifer, Dunn, Imogene, Dvergsten, Chris, Madduri, Supradeep, Giovannetti, Erin, Valcarce, Carmen, Buse, John, Pettus, Jeremy, Klein, Klara, and Boeder, Schafer

Subjects
Bicarbonates, Blood Glucose, Diabetes Mellitus, Type 1, Diabetic Ketoacidosis, Glucokinase, Humans, Hypoglycemia, Insulin, Insulin, Regular, Human, Ketosis, Organic Chemicals
Abstract

AIMS: To determine the effect of TTP399, a hepatoselective glucokinase activator, on the risk of ketoacidosis during insulin withdrawal in individuals with type 1 diabetes (T1D). MATERIALS AND METHODS: Twenty-three participants with T1D using insulin pump therapy were randomized to 800 mg TTP399 (n = 12) or placebo (n = 11) for 7 to 10 days. After the treatment period, an insulin withdrawal test (IWT) was performed, during which insulin pumps were removed to induce ketogenesis. The IWT was stopped after 10 hours or if blood glucose reached >399 mg/dL [22.1 mmol/L], if beta-hydroxybutyrate (BHB) was >3.0 mmol/L, or for patient discomfort. The primary endpoint was the proportion of participants who reached BHB concentrations of 1 mmol/L or greater. RESULTS: During the 7- to 10-day treatment period, mean fasting plasma glucose was significantly reduced ( -27.6 vs. -4.4 mg/dL [-1.5 vs. -0.2 mmol/L]; P = 0.03) and there were fewer adverse events, including hypoglycaemia, in the TTP399-treated arm. During the IWT, no differences were observed between TTP399 and placebo in mean serum BHB concentration, mean duration of IWT, or BHB at termination of IWT. However, serum bicarbonate was numerically higher and urine acetoacetate was quantitatively lower in the TTP399-treated participants. As a result of higher bicarbonate values, none of the TTP399-treated participants met the prespecified criteria for diabetic ketoacidosis (DKA), defined as BHB >3 mmol/L and serum bicarbonate

Published
2022

3. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial

Author

Files, D. Clark, Aggarwal, Neil, Albertson, Timothy, Auld, Sara, Beitler, Jeremy R., Berger, Paul, Burnham, Ellen L., Calfee, Carolyn S., Cobb, Nathan, Crippa, Alessio, Discacciati, Andrea, Eklund, Martin, Esserman, Laura, Friedman, Eliot, Gandotra, Sheetal, Khan, Kashif, Koff, Jonathan, Kumar, Santhi, Liu, Kathleen D., Martin, Thomas R., Matthay, Michael A., Meyer, Nuala J., Obermiller, Timothy, Robinson, Philip, Russell, Derek, Thomas, Karl, Wong, Se Fum, Wunderink, Richard G., Wurfel, Mark M., Yen, Albert, Youssef, Fady A., Darmanian, Anita, Dzierba, Amy L., Garcia, Ivan, Gosek, Katarzyna, Madahar, Purnema, Mittel, Aaron M., Muir, Justin, Rosen, Amanda, Schicchi, John, Serra, Alexis L., Wahab, Romina, Gibbs, Kevin W., Landreth, Leigha, LaRose, Mary, Parks, Lisa, Wynn, Adina, Ittner, Caroline A.G., Mangalmurti, Nilman S., Reilly, John P., Harris, Donna, Methukupally, Abhishek, Patel, Siddharth, Boerger, Lindsie, Kazianis, John, Higgins, Carrie, McKeehan, Jeff, Daniel, Brian, Fields, Scott, Hurst-Hopf, James, Jauregui, Alejandra, Brown Swigart, Lamorna, Blevins, Daniel, Nguyen, Catherine, Suarez, Alexis, Tanios, Maged A., Sarafian, Farjad, Shah, Usman, Adelman, Max, Creel-Bulos, Christina, Detelich, Joshua, Harris, Gavin, Nugent, Katherine, Spainhour, Christina, Yang, Philip, Haczku, Angela, Hardy, Erin, Harper, Richart, Morrissey, Brian, Sandrock, Christian, Budinger, G. R. Scott, Donnelly, Helen K., Singer, Benjamin D., Moskowitz, Ari, Coleman, Melissa, Levitt, Joseph, Lu, Ruixiao, Henderson, Paul, Asare, Adam, Dunn, Imogene, and Botello Barragan, Alejandro

Published
2023
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4. Trend in Clinical Trial Participation During COVID-19: A Secondary Analysis of the I-SPY COVID Clinical Trial

Author

Yang, Philip, Dickert, Neal W., Haczku, Angela, Spainhour, Christine, Auld, Sara C., Aggarwal, Neil R., Albertson, Timothy, Auld, Sara, Beitler, Jeremy R., Berger, Paul, Burnham, Ellen L., Calfee, Carolyn S., Cobb, Nathan, Crippa, Alessio, Discacciati, Andrea, Eklund, Martin, Esserman, Laura, Files, D. Clark, Friedman, Eliot, Gandotra, Sheetal, Khan, Kashif, Koff, Jonathan, Kumar, Santhi, Liu, Kathleen D., Martin, Thomas R., Matthay, Michael A., Meyer, Nuala J., Obermiller, Timothy, Robinson, Philip, Russell, Derek, Thomas, Karl, Wong, Se Fum, Wunderink, Richard G., Wurfel, Mark M., Yen, Albert, Youssef, Fady A., Darmanian, Anita, Dzierba, Amy L., Garcia, Ivan, Gosek, Katarzyna, Madahar, Purnema, Mittel, Aaron M., Muir, Justin, Roden, Amanda, Schicchi, John, Serra, Alexis L., Wahab, Romina, Gibbs, Kevin W., Landreth, Leigha, LaRose, Mary, Parks, Lisa, Wynn, Adina, Ittner, Caroline A. G., Mangalmurti, Nilam S., Reilly, John P., Harris, Donna, Methukupally, Abhishek, Patel, Siddharth, Boerger, Lindsie, Kazianis, John, Higgins, Carrie, McKeehan, Jeff, Daniel, Brian, Fields, Scott, Hurst-Hopf, James, Jauregui, Alejandra, Swigart, Lamorna Brown, Belvins, Daniel, Nguyen, Catherine, Suarez, Alexis, Tanios, Maged A., Sarafian, Farjad, Shah, Usman, Adelman, Max, Creel-Bulos, Christina, Detelich, Joshua, Harris, Gavin, Nugent, Katherine, Spainhour, Christine, Yang, Philip, Haczku, Angela, Hardy, Erin, Harper, Richart, Morrissey, Brian, Sandrock, Christian, Budinger, G. R. Scott, Donnelly, Helen K., Singer, Benjamin D., Moskowitz, Ari, Coleman, Melissa, Levitt, Joseph, Lu, Ruixiao, Henderson, Paul, Asare, Adam, Dunn, Imogene, and Barragan, Alejandro Botello

Published
2023
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5. Evaluation of symptom severity, tolerability, and physical function in the I-SPY2 trial.

Author

Basu, Amrita B, primary, Umashankar, Saumya, additional, Musthafa, Mina, additional, Jones, Tamia, additional, Blevins, Kaylee, additional, Brown, Thelma, additional, Heditsian, Diane, additional, Parker, Beverly, additional, Brain, Susie, additional, Simmons, Carol, additional, Hieken, Tina J., additional, Ruddy, Kathryn Jean, additional, Mainor, Candace Bavette, additional, Tevis, Sarah Emily Amend, additional, Blaes, Anne Hudson, additional, Rugo, Hope S., additional, Dunn, Imogene, additional, Melisko, Michelle E., additional, Esserman, Laura, additional, and Hershman, Dawn L., additional

Published
2023
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9. eSource records in clinical research: keeping it simple: how to satisfy regulatory concerns about EDC data integrity and site controls over its source records

Author

Mitchel, Jules T., Helfgott, Jonathan, Haag, Tom, Cappi, Silvana, Dunn, Imogene McCanless, Kim, Yong Joong, Choi, Joonhyuk, Cho, Timothy, and Gittleman, Dean

Subjects
United States. Food and Drug Administration -- Health policy, Health policy, Information management, Methods, Laws, regulations and rules, Clinical trials -- Methods -- Information management -- Laws, regulations and rules, Regulatory compliance -- Methods
Abstract

There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process. In 2008, the Clinical Trial Transformational Initiative (CTTI), a public-private partnership [...]

Published
2015

18. The SimpliciT1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Adaptive Study of TTP399, a Hepatoselective Glucokinase Activator, for Adjunctive Treatment of Type 1 Diabetes.

Author

Klein, Klara R., Freeman, Jennifer L.R., Dunn, Imogene, Dvergsten, Chris, Kirkman, M. Sue, Buse, John B., Valcarce, Carmen, Bergamo, Katherine A., Harris, Elizabeth H., Dostou, Jean M., Young, Laura A., Machineni, Sriram, Kass, Alex M., Diner, Jamie C., Dezube, Milana, Purrington, Virginia C., Uehling, Julie M., Fraser, Rachael M., Schuch, Katherine R., and Rowell, Jennifer V.

Subjects
TYPE 1 diabetes, GLUCOKINASE, GLYCEMIC control, SUBCUTANEOUS infusions, HYPOGLYCEMIA, RESEARCH, RESEARCH methodology, HYPOGLYCEMIC agents, ORGANIC compounds, MEDICAL cooperation, EVALUATION research, TREATMENT effectiveness, INSULIN, COMPARATIVE studies, RANDOMIZED controlled trials, TRANSFERASES, BLIND experiment
Abstract

Objective: Despite advances in exogenous insulin therapy, many patients with type 1 diabetes do not achieve acceptable glycemic control and remain at risk for ketosis and insulin-induced hypoglycemia. We conducted a randomized controlled trial to determine whether TTP399, a novel hepatoselective glucokinase activator, improved glycemic control in people with type 1 diabetes without increasing hypoglycemia or ketosis.Research Design and Methods: SimpliciT1 was a phase 1b/2 adaptive study. Phase 2 activities were conducted in two parts. Part 1 randomly assigned 20 participants using continuous glucose monitors and continuous subcutaneous insulin infusion (CSII). Part 2 randomly assigned 85 participants receiving multiple daily injections of insulin or CSII. In both parts 1 and 2, participants were randomly assigned to 800 mg TTP399 or matched placebo (fully blinded) and treated for 12 weeks. The primary end point was change in HbA1c from baseline to week 12.Results: The difference in change in HbA1c from baseline to week 12 between TTP399 and placebo was -0.7% (95% CI -1.3, -0.07) in part 1 and -0.21% (95% CI -0.39, -0.04) in part 2. Despite a greater decrease in HbA1c with TTP399, the frequency of severe or symptomatic hypoglycemia decreased by 40% relative to placebo in part 2. In both parts 1 and 2, plasma β-hydroxybutyrate and urinary ketones were lower during treatment with TTP399 than placebo.Conclusions: TTP399 lowers HbA1c and reduces hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes. [ABSTRACT FROM AUTHOR]

Published
2021
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28. Risk-Based Monitoring.

Author

Tantsyura, Vadim, Dunn, Imogene McCanless, Fendt, Kaye, Kim, Yong Joong, Waters, Joel, and Mitchel, Jules

Subjects
CLINICAL medicine research, CLINICAL trials, DATABASE management, DOCUMENTATION, QUALITY assurance, RISK management in business, SAMPLE size (Statistics), DATA analysis, MEASUREMENT errors, DESCRIPTIVE statistics
Abstract

Background: Data quality within the clinical research enterprise can be defined as the absence of errors that matter and whether the data are fit for purpose. This concept, proposed by the Clinical Trials Transformation Initiative, resulted from a culmination of collaboration with industry, academia, patient advocates, and regulators, and it emphasizes the presence of a hierarchy of error types, resulting in a more efficient and modern data-cleaning paradigm. While source document verification (SDV) is commonly used as a quality control method in clinical research, it is disproportionately expensive and often leads to questionable benefits. Although the current literature suggests that there is a need to reduce the burden of SDV, there is no consensus on how to replace this “tried and true” practice. Methods: This article proposes a practical risk-based monitoring approach based on published statistical evidence addressing the impact of database changes subsequent to SDV. Results: The analysis clearly demonstrates minimal effects of errors and error corrections on study results and study conclusions, with diminishing effect as the study size increases, and it suggests that, on average, <8% SDV is adequate to ensure data quality, with perhaps higher SDV rates for smaller studies and virtually 0% SDV for large studies. Conclusions: It is recommended that SDV, rather than just focusing on key primary efficacy and safety outcomes, focus on data clarification queries as highly discrepant (and the riskiest) data. [ABSTRACT FROM AUTHOR]

Published
2015
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