Through control and supervision of medical devices and pharmaceuticals, the FDA plays a crucial role in effectively protecting the public health in the United States. While the COVID-19 pandemic has developed ongoing challenges for the industry, the FDA has provided a guidance document for conducting clinical trials of medical products during the pandemic. Standards and compliances established by the Agency regulate the safety and efficacy of these products. Guidance documents are maintained and provided to assist in the conduct of clinical trials.
The COVID-19 public health emergency has impacted the conduct of clinical trials due to quarantines, site closures, travel limitations, and other interruptions. These challenges vary depending on various factors, such as the trial design and the location of the study. Thus, the Agency recognizes that studies may require changes. This guidance document provides considerations to assure trial participants’ safety, maintain compliance with good clinical practice (GCP), and minimize risks to trial integrity.
Recommendations provided include:
- Modifying study conduct accordingly to ensure safety
- Evaluate alternative methods for trial participants
- Take into account COVID-19 standards in the health care system
- Consider the delay of a trial
- Explore alternative administration possibilities
- Define procedures to prioritize reporting of deviations
- Document all reasons for failure to obtain efficacy endpoints
- Address in the Statistical Analysis Plan (SAP) how protocol deviations related to COVID-19 will be handled
