The U.S. Food and Drug Administration (FDA) recently released its long-awaited draft guidance supporting the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices. The new guidance clarifies the FDA’s position on DCTs, inspiring confidence in their use for future clinical research.
DCTs are a type of clinical trial where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as trial participants’ homes or local facilities. The most common form of DCT is referred to as “hybrid,” in which the trial leverages some aspects of traditional on-site trials and some virtual elements. Recent data shows hybrid trials are now more common than traditional on-site trials and are projected to account for up to 77% of all clinical trials in 2022.
We see the FDA’s announcement as a significant step forward for the industry as it proactively encourages decentralization which can benefit patients, sponsors, and providers if implemented properly. FDA Commissioner Robert M. Califf, M.D. notes, “…decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.”
The FDA’s announcement provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of DCTs. Pattern Health has been on the leading edge of DCT technology for years. Pattern has powered many fully-decentralized and hybrid trials such as CONNECT-HF (sponsored by Duke Clinical Research Institute), the first study to incorporate mobile health technology to follow heart failure patients long-term. Our Research & Clinical Trials Solution includes a unique combination of no-code configuration tools, supporting services, a library of integrated devices and industry services (EDC), and a catalog of clinical outcomes assessments to enable efficient DCTs.
At Pattern, we are excited to continue supporting the industry’s move toward decentralized clinical trials. Learn more about how Pattern could benefit your DCTs here: Research & Clinical Trials Solution