Meeting Trial Participants Where They Are
The COVID-19 pandemic significantly dislocated the operational model of traditional clinical trials as travel restrictions and the diversion of finite health care resources led to significant declines in trial activation, enrollment, and data collection. However, the exigent need to continue therapeutic trials fostered an innovation in trial operations termed decentralized clinical trials (DCTs). DCTs are trials wherein elements of research conduct (drug delivery, adverse event assessments, imaging, and laboratory draws) are delivered remote from the primary clinical trial site and closer to a patient's home. This approach leverages digital tools, mobile or community-based providers (imaging facilities, ambulatory clinics, and laboratory centers), and a supply chain to eliminate the need for routine in-person interactions. Pandemic-related policies such as relaxation of the regulatory climate for telemedicine and improvements in the infrastructure supporting same-day home delivery of medications accelerated DCT adoption. Furthermore, the U.S. Food and Drug Administration published regulatory guidance on the use of digital health tools for obtaining informed consent, remote safety monitoring, and clinical end point assessments. In this article, we provide an overview of multidisciplinary DCTs with a focus on surgery, and draw attention to opportunities for enhancing trial accrual and participant diversity.
Read the full text in JCO Oncology Practice.