The Petrie Flom Center at the Harvard Law School reports that clinical trials (CTs) related to COVID-19 exploded in the U.S., with an unprecedented 811 COVID-related CTs through October 2020. With the distance that COVID-19 has necessitated, CTs began to look and function differently than they had traditionally. In fact, 40% of clinical trials moved to a Decentralized Clinical Trial (DCT) model, which includes home health visits, direct patient drug and supply delivery, and data collection by portable devices. Further, 64% of CTs used telemedicine during the pandemic.
This trend toward DCTs has many benefits, including increased efficiency and increased patient participation and engagement, driven by the use online tools such as electronic appointment reminders sent via smart phones, online patient diaries and wearable devices used in data collection. The use of DCTs has also resulted in increased diversity with ¾ of patients preferring alternative models such as DCTs, including women and African-Americans preferring home visits and the home data collection model.
However, the use of DCTs also presents challenges related to patient safety as study sites and sponsors must take care to identify adverse events and facilitate patient medical care if needed. The trend towards DCTs also raises regulatory concerns as sponsors must consider whether or not other health care providers should be designated as additional investigators or sub-investigators. The increased use of technology also raises concerns about data security as sites and sponsors are entering into monitoring contracts to ensure protected health information.
Todd Lauer, Sompo GRS Life Science Industry Leader, observes, “As DCTs gain momentum within the life science community, trial sponsors should be aware of the unique exposures arising from this new virtual approach to clinical trials. For example, given the reliance on remote trial management via the internet, mobile apps, or other connectivity, i.e. IoT, there is an increased exposure to a potential breach of patient confidential information. Additional areas of concern would be the erosion of informed consent as well as adherence or compliance challenges to the clinical trial protocol that may lead to more adverse events.”
Mr. Lauer adds, “In order to gain control over these and other exposures or liabilities, sponsors should develop a DCT or virtual clinical trial risk mitigation strategy by leveraging the expertise from a multi-disciplinary team including legal, regulatory and clinical affairs, plus your life science insurance broker and underwriter. This strategy will ensure that the overall clinical trial implementation process ensures the safety of participants and secures the data integrity of the clinical trial.”
“With a comprehensive risk mitigation strategy in place, DCTs are a net positive over traditional clinical trials,” observes Mr. Lauer.