During 2020 and 2021, the COVID-19 pandemic has resulted in interruptions and cancellations of clinical trials and has delayed drug development in all areas except SARS-CoV-2 vaccine development. A further concern is the need to rapidly share anonymized datasets and improve opportunities to conduct randomized clinical trials (RCTs) in low-resource developing countries, particularly for oncology trials and for other infectious diseases. The Consolidated Standards of Reporting Trials (CONSORT) 2010 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 currently guide the reporting of trial protocols and completed RCTs, respectively. Extenuating circumstances or unavoidable situations may occur that are beyond the control of study sponsors and investigators. On June 21, 2021, the CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance (CONSERVE) was published. The scope of CONSERVE 2021 includes modifications that have substantive implications for the feasibility, ethical conduct, scientific content, and study analysis. This Editorial aims to provide the background to CONSERVE 2021 and show how these guidelines may reduce the number of clinical trials currently being paused or discontinued due to the COVID-19 pandemic, particularly in poorly resourced and developing countries.
Editorial: Reporting Clinical Trials with Important Modifications Due to Extenuating Circumstances, Including the COVID-19 Pandemic: CONSERVE 2021