The FDA Perspective
By: Laurie Smaldone, CMO/CSO, NDA Group
In this white paper, NDA’s Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.
The virus SARS-CoV-2 and the resulting COVID-19 disease have created devastating impacts around the globe on lives and livelihood, including major disruption of ongoing research and development activities for innovative therapies. From many perspectives the spread of SARS-CoV-2 has impacted and will continue to impact ongoing global registrational programs for a variety of disorders especially those not directly addressing the treatment or prevention of the SARS-CoV-2.
This disruption impacts all facets of the drug development process, from the Sponsor company, to the supply chain of investigational treatments to the productivity of study sites. The FDA has issued guidance to address the challenges that may arise from a range of disruptions that could impact the validity and integrity of clinical programs.
The FDA has noted that the spread of the virus may lead to GCP violations and protocol deviations, including impact on trial endpoints and safety collection. FDA’s Center for Drug Evaluation and Research Director Janet Woodcock stated that “trials may be able to shift to tele-outcome assessments”, but others “may be damaged and may have to halt and not start up again until we can interact more freely”.
FDA’s recent guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” addresses the potential impacts to ongoing trials. The guidance provides stakeholders in the drug development and approval process with critical considerations for ongoing trials.
Potential COVID-19 impacts
Trials may be impacted in a variety of ways. Some sites have had to close down or have witnessed significant recruitment delays due to the inability of patient travel, illness, or redeployment of study personnel to address COVID-19 patients or trials. These limitations can greatly impact study continuity and procedures to maintain study integrity. In making decisions on trial continuity, Sponsors will need to do a robust assessment of trial conduct that may impact patient safety, GCP, drug storage and administration, and protocol procedures .