The FDA recently released new guidance on clinical trials in the face of COVID-19. In their published report, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, they acknowledged that challenges may arise in ongoing trials. For example, quarantines, site closures, travel limitations, etc. may lead to difficulties in meeting protocol-specified procedures including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. The FDA stated that they recognize protocol modifications may be required, and that there may be unavoidable protocol deviations.
Consider Potential Ramifications When Making Protocol Modifications
Serious consideration should be given to assure the safety of trial participants while maintaining compliance with good clinical practice (GCP) and minimizing risks to trial integrity. In cases where there is a need for deviation and it is determined that it can be done safely and without adverse effects, sponsors should look to do so. Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19. Efforts to minimize impacts on trial integrity, and to document the reasons for protocol deviations, are required.
Regarding the option for incorporating virtual visits into existing protocol, it is recommended when necessary and feasible and when it would sufficiently assure the safety of trial participants. Sponsors should determine if/when in-person visits are needed and when virtual visits can safely suffice.
Virtual Visits May Incorporate Home Health Workers
Review existing protocol and determine the necessity for modifications. If there is concern for patient safety, consider a combination of virtual visits and home health workers. Collaboration between home health professionals and PIs using telemedicine provides flexibility because it enables a home health professional to conduct certain procedures that require the oversight of a PI. For example, a home health professional, along with the patient, can connect via a telemedicine consultation with the PI for more complex appointments such as conducting a physical exam before administering an infusion therapy.
The technology is available today for hybrid decentralized trials and the number of professional clinicians that are trained on telemedicine and prepared to conduct DCTs is growing. Request a proposal for support developing protocol amendments and expediting approvals, or contact us to learn more about our device-agnostic telemedicine platform that is customized for clinical trials and works with any research site worldwide.
*Content regarding specific guideline recommendations was taken from the FDA published document: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic