searchMECFS: An online, interactive platform to facilitate secondary use of biospecimens and associated research data from myalgic encephalomyelitis studies
September 2026
COVID-19’s impact on clinical research
Key Points
- Research activities were paused in the beginning of the COVID-19 pandemic, which allowed the integrity of clinical trials to be maintained due to regulatory agencies implementing appropriate and timely guidance documents.
- Research regulatory agencies, such as the Food and Drug Administration (FDA), released more than 70 guidance documents related to conducting clinical research during the COVID-19 pandemic and continues to update these periodically.
- Guidance documents released cover a variety of topics and select audiences (i.e., sponsors, investigators, and sites).
Abstract
During the COVID-19 pandemic, federal and state restrictions hindered many aspects of clinical trials, such as recruiting patients, which made completing required research tasks difficult or impossible. Many existing guidance documents and policies were redesigned rapidly during the pandemic to accommodate COVID-19-related emergencies. Such policies laid the foundation for change in clinical research. The purpose of this clinical research regulatory review is to determine how regulatory bodies such as the Food and Drug Administration, Office of Human Research Protections, and institutional review boards have responded to challenges in running clinical trials during the COVID-19 pandemic.
© 2026 RTI International. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
