Regulators recognize that COVID-19 may impact clinical trials of drugs, devices and biological products. Programs for COVID-19 are taking precedence over some other programs, which may experience delays. Biopharmaeutical companies may also prioritize their programs for COVID-19. Regulatory agencies are releasing guidance documents for the conduct of clinical trials during the COVID-19 pandemic. See resources below and go to the regulatory agency website for the most recent information.
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
- Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19