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Editorial: Reporting Clinical Trials with Important Modifications Due to Extenuating Circumstances, Including the
1Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.
Abstract:
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.
Insights
The COVID-19 pandemic disrupted clinical trials, necessitating new guidelines. CONSERVE 2021 offers solutions for conducting randomized clinical trials (RCTs) during extenuating circumstances, especially in developing nations.
Area of Science:
- Clinical Trials
- Pandemic Response
- Global Health Equity
Background:
- COVID-19 pandemic significantly disrupted drug development and clinical trials globally, except for SARS-CoV-2 vaccines.
- There is a critical need for rapid anonymized data sharing and enhanced randomized clinical trials (RCTs) in low-resource settings, particularly for oncology and infectious diseases.
- Existing guidelines like CONSORT 2010 and SPIRIT 2013 needed adaptation for unforeseen global events.
Discussion:
- The CONSERVE 2021 guidelines address extenuating circumstances impacting clinical trial conduct, feasibility, and ethics.
- CONSERVE 2021 provides modifications crucial for maintaining trial integrity and scientific validity amidst global crises.
- These extensions aim to prevent unnecessary pausing or discontinuation of vital research, especially in resource-limited regions.
Key Insights:
- CONSERVE 2021 offers a framework to adapt clinical trial protocols and reporting during unforeseen disruptions.
- The guidelines emphasize maintaining scientific rigor and ethical standards in clinical research under challenging conditions.
- Focus on low-resource countries addresses critical gaps in global health research and drug development.
Outlook:
- CONSERVE 2021 is expected to improve the resilience of clinical trials against future pandemics and global disruptions.
- Implementation of these guidelines can foster greater participation in global health research, particularly in developing countries.
- This initiative supports the continuation of essential research, ensuring progress in oncology and infectious disease treatment development.
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