Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances

Orkin, Aaron; Gill, Peter; Ghersi, Davina; Campbell, Lisa; Sugarman, Jeremy; Emsley, Richard; Gabríel Steg, Philippe; Weijer, Charles; Simes, John; Rombey, Tanja; C Williams, Hywel; Wittes, Janet; Moher, David; P. Richards, Dawn; L. Kasamon, Yvette; Getz, Kenneth; Hopewell, Sally; Dickersin, Kay; Wu, Taixiang; Patricia Ayala, Ana; F. Schulz, Kenneth; Calleja, Sabine; Boutron, Isabelle; S. Ross, Joseph; Golub, Robert; Khan, Karim; Mulrow, Cindy; Siegfried, Nandi; Heber, Joerg; Lee, Naomi; Reed Kearney, Pamela; K. Wanyenze, Rhoda; Hróbjartsson, Asbjørn; J. Williams, Rebecca; Bhandari, Nita; Jüni, Peter; Chan, An‐Wen; Group, CONSERVE; Orkin, Aaron; J. Gill, Peter; Ghersi, Davina; Campbell, Lisa; Sugarman, Jeremy; Emsley, Richard; Gabriel Steg, Philippe; Weijer, Charles; Simes, John; Rombey, Tanja; C Williams, Hywel; Wittes, Janet; Moher, David; P. Richards, Dawn; L. Kasamon, Yvette; Getz, Kenneth; Hopewell, Sally; Dickersin, Kay; Wu, Taixiang; Patricia Ayala, Ana; F. Schulz, Kenneth; Calleja, Sabine; Boutron, Isabelle; S. Ross, Joseph; M. Golub, Robert; Khan, Karim; Mulrow, Cindy; Siegfried, Nandi; Heber, Joerg; Lee, Naomi; Reed Kearney, Pamela; K. Wanyenze, Rhoda; Hróbjartsson, Asbjørn; Williams, Rebecca; Bhandari, Nita; Jüni, Peter; Chan, An‐Wen; Kiermer, Véronique; Corrigan‐Curay, Jacqueline; Concato, John

doi:10.1001/jama.2021.9941

Public

Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances

Published in JAMA • Jun 21, 2021

Authors:

Aaron Orkin

Peter Gill

Davina Ghersi

Abstract

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-1...

Subject

Medicine

Coronavirus disease 2019 (COVID-19)

Pandemic

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