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FDA Guidance on Conduct of Clinical Trials During COVID-19
Q&A with FDA Deputy Commissioner for Medical and Scientific Affairs

n late March 2020, the US Food and Drug Administration (FDA) issued its Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards. “Sponsors in consultation with the investigators and institutional review boards should assess whether the protection of a patient’s safety, welfare, and rights are best served by continuing the study participant in the trial as per the protocol, modify the protocol to minimize risk such as by using telemedicine wherever possible, or by discontinuing the administration or use of the investigational product or even participation in the trial,” explains FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah in an interview with DIA.

Global Forum: What considerations contained in the Guidance will help sponsors simultaneously protect the rights of trial participants and clinical data integrity?

Anand Shah: The Guidance speaks to conducting safety assessments using remote technology. It also provides guidance on remote capture of endpoints such as the performance outcomes and clinician-reported outcome assessments using remote technology. And, to maintain data integrity, our guidance reminds sponsors of the need to document the changes that are being made and how COVID-19 impacted the collection of data from participants at the individual participant and trial site. And finally, it’s critical to determine whether the conduct of the trial could interfere with public health measures implemented to control the virus and to keep participants informed.

With regard to remote participant follow-up visits, the increasing use of telemedicine really represents a potential alternative. The investigators, study personnel, who will conduct remote visits should be trained on how to conduct real time electronic interactions. These are certainly different, and procedures should be put in place to maintain a trial participant’s privacy as you would for any in-person clinical visit. As noted, we provide guidance on considerations for conducting performance outcomes using remote technology, and sponsors can also contact the review division at FDA regarding any proposals to change clinical trial conduct.

GF: What should sponsors do when an IRB is not available due to COVID-19 impact and restrictions, and a protocol modification or deviation requires IRB approval, at least according to the usual GCP requirements?

AS: Our regulations permit IRBs to meet remotely, to use consultants to provide specialized expertise, and allow an IRB to rely on another IRB to review its trial. Although changes in a protocol are typically not implemented before review and approval by the IRB and in some cases by FDA, changes to the protocol or investigational plan to minimize or eliminate immediate hazards, or to protect the life and well-being of research participants such as limiting exposure to COVID-19, may be implemented without IRB approval or before filing an amendment to the investigational new drug or investigational device exemption, but these changes are required to be reported afterwards.

We’re encouraging sponsors to prioritize reporting of deviations that may impact the safety of trial participants and for changes that are implemented for the protocol as a whole versus a subset of participants, a protocol amendment should be sent to FDA. And we’re recognizing that during this rapidly evolving pandemic, a sequence of changes may be needed to address those circumstances; consolidating several protocol modifications into a single protocol amendment would be acceptable but should be done expeditiously.

GF: What have you seen to date that will help sponsors, investigators, regulators, and patients be better prepared for any future pandemics that may impact clinical trials?

AS: I’m fairly confident that in the near future we will return to some sense of normalcy. It may not be a light switch, it may be more like a sunrise, and we’ll see gradual return to our normal procedures and operations as an agency. We have learned a lot of lessons and we continue to learn about some potential durable changes that we may be able to make with respect to flexibilities.