Critical Care Explorations (Jun 2023)

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

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

DOI
https://doi.org/10.1097/CCE.0000000000000930
Journal volume & issue
Vol. 5, no. 6
p. e0930

Abstract

Read online

OBJECTIVES:. To analyze the temporal trend in enrollment rates in a COVID-19 platform trial during the first three waves of the pandemic in the United States. DESIGN:. Secondary analysis of data from the I-SPY COVID randomized controlled trial (RCT). SETTING:. Thirty-one hospitals throughout the United States. PATIENTS:. Patients who were approached, either directly or via a legally authorized representative, for consent and enrollment into the I-SPY COVID RCT. INTERVENTIONS:. None. MEASUREMENTS AND MAIN RESULTS:. Among 1,338 patients approached for the I-SPY COVID trial from July 30, 2020, to February 17, 2022, the number of patients who enrolled (n = 1,063) versus declined participation (n = 275) was used to calculate monthly enrollment rates. Overall, demographic and baseline clinical characteristics were similar between those who enrolled versus declined. Enrollment rates fluctuated over the course of the COVID-19 pandemic, but there were no significant trends over time (Mann-Kendall test, p = 0.21). Enrollment rates were also comparable between vaccinated and unvaccinated patients. In multivariable logistic regression analysis, age, sex, region of residence, COVID-19 severity of illness, and vaccination status were not significantly associated with the decision to decline consent. CONCLUSIONS:. In this secondary analysis of the I-SPY COVID clinical trial, there was no significant association between the enrollment rate and time period or vaccination status among all eligible patients approached for clinical trial participation. Additional studies are needed to better understand whether the COVID-19 pandemic has altered clinical trial participation and to develop strategies for encouraging participation in future COVID-19 and critical care clinical trials.