As COVID-19 continues to impact research organizations and clinical sites, federal agencies are issuing guidance for clinical trials. Organizations are closing or dramatically reducing operations and on-site staff; supply chains are disrupted; and travel restrictions have left investigators, organizations, and sponsors scrambling to respond. In response, the FDA is providing guidance for those impacted. The National Institutes of Health (NIH) issued guidance on March 16 that provides some flexibility for NIH-funded studies.
The objectives of the guidance documents, which are non-binding and not legally enforceable, are to:
- Ensure the safety of trial participants
- Maintain Good Clinical Practice (GCP)
- Minimize risk to research integrity
The disruption in everyday life is leading to challenges in the ability to conduct scheduled protocol-defined procedures, obtain investigational drugs or supplies, or conduct laboratory or diagnostic tests. Sponsors and organizations are advised to consider the above objectives as they establish their own response plans and procedures.
Some highlights from the FDA’s guidance:
Clear and timely communication with trial participants
Whether a sponsor or investigator decides to delay recruitment, modify monitoring procedures or schedules, or change anything about the administration of the investigational drug, it is essential that trial participants are continuously informed.
Consult with IRBs
Decisions should be made in consultation with IRBs to determine the impact on patient safety, welfare, and rights. A variety of factors, including access to the investigational drug and the ability to safely conduct monitoring, should be part of the decision-making process.
Consider alternatives to in-person monitoring
Already we are seeing an increase in the use of telemedicine for clinical visits. Trial participants may find it difficult or impossible to come to the research site for a scheduled visit. If an in-person visit is not absolutely required, sponsors and investigators can consider alternatives, including phone contact, video conference, alternative sites, etc.
Evaluate the implications of decisions
Many decisions have a systemic impact. For example, if a trial participant will no longer be taking an investigational drug, additional monitoring may be necessary. Outline potential implications and how to address them.
Changes in protocols — from disruption of study visits to study discontinuation — should be carefully documented and should include the reason for the variance, particularly if it is COVID-19 related. This documentation, including the tracking of unanticipated expenses, may be helpful in applying for administrative supplements to NIH grants.
These recommendations may change or evolve as the situation unfolds. When it doubt, please consult directly with the appropriate IRB, the FDA, NIH or other regulatory body.