mdi ConsultantsThe COVID-19 pandemic interrupted many aspects of our lives as we know it. One of the critical concerns on the FDA list is how to handle the ongoing clinical studies during the current pandemic. With that in mind, FDA issued a new document titled “FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”.
The purpose of this guidance is to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
FDA cites examples of possible challenges related to the COVID-19 pandemic that may impact the conduct of clinical trials. These may include clinical site closures, travel limitations, quarantine of study participants and study personnel, interruptions to the supply chain for the investigational product and other challenges that can lead to difficulties in meeting protocol-specified procedures such as administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing.
FDA recognizes that there may be unavoidable protocol deviations due to COVID-19 illness or COVID-19 control measures and that clinical protocol modifications may be necessary.
FDA highlights decision making criteria that study sponsors can use when evaluating their specific set of circumstances. For example, the study sponsor along with their Institutional Review Board (IRB) should consider if the safety, welfare and rights of the study participants are best served by continuing with the administration/use of investigational medical product or its discontinuation and if necessary, complete disenrollment from the study. Sponsors should also determine if alternative monitoring measures for study participants (e.g., by phone, virtual visit, different site) can be used in place of on-site visits.
The main point is that changes to the clinical protocol should be done with a review and approval by the IRB and in some cases, by FDA. Sponsors and clinical investigators are encouraged to engage with IRB as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19.
FDA also notes the COVID-19 screening procedures that may be mandated by the health care system in which a clinical trial is being conducted do not need to be reported as an amendment to the protocol even if done during clinical study visits (unless the sponsor is incorporating the data collected as part of a new research objective).
Sponsors, clinical investigators, and IRBs should consider establishing and implementing policy, or revise existing policy and procedures, to describe approaches to be used to protect trial participants and manage study conduct during possible disruption as a result of COVID-19 control measures at study sites. Such policy and procedures should address impact on the informed consent process, study visits and procedures, data collection, study monitoring, adverse event reporting, and changes in investigator(s), site staff, and/or monitor(s) secondary to travel restrictions, quarantine measures, or COVID-19 illness itself.
You can review the full text of FDA guidance here: FDA guidance
If your company has questions about your ongoing or future clinical studies, mdi Consultants will gladly review your situation and provide recommendations. Please reach out to us at [email protected]