COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are

Bill of Health

Sarah V. Ferranti, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Boston office, co-authored an article in the Petrie-Flom Center’s Bill of Health at Harvard Law School, titled “COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are.”

Following is an excerpt:

“Decentralized” clinical trials (referred to as “DCTs”) are not novel, but nevertheless failed to gain real momentum given the regulatory and operational complexities involved. In light of COVID-19, however, it seems almost certain that the remote and virtual study activities that characterize DCTs, and a site and sponsor’s ability to flex to “meet the participant where they are” will be critical to the conduct of clinical trials going forward.

In the first half of 2020, as health care facilities prepared for capacity-exceeding patient volumes and equipment shortages, non-essential clinical care and non-COVID-related clinical trials came to a screeching halt. According to ClinicalTrials.gov, 1473 clinical trials were suspended, terminated, or withdrawn between December 1, 2019 and July 1, 2020, with a reported reason that explicitly mentioned COVID-19.

At the same time, initiation of clinical trials for COVID-19 vaccines and treatments exploded at speeds previously considered unachievable within the clinical trial industry. As of October 13, 2020, 811 COVID-19-related clinical trials had been initiated in the United States. To enable COVID-19 trials and, more recently, to restart previously paused non-COVID trials, clinical trial sponsors and sites have been forced to quickly adapt to protect participants and preserve the integrity of clinical trial data and results.

The Tufts Center for the Study of Drug Development (“TCSDD”) has reported that 40 percent of trials ongoing at the time of the outbreak of SARS-CoV-2 moved to models that included home health visits, direct-to-patient drug and supply delivery, and collection of data by portable devices. Likewise, WIRB-Copernicus Group has reported that 64% of clinical trial sites have used telemedicine “sometimes,” “often,” or “always” during the COVID-19 pandemic.

This transition effectively “decentralizes” the participant experience, moving trial-related activities away from a single site and to a participant’s home or health care providers within the participant’s local community.