Digital Technology in Clinical Trials

The Critical Path Institute (C-Path) creates precompetitive public-private partnerships that bring together stakeholders to improve the process of medical product development. Several consortia within C-Path are pursuing research related to remote monitoring technologies, e.g., wearable devices or activity monitors, in order to support their use in clinical trials and research. This session will highlight two case examples: one from the Critical Path to Parkinson’s (CPP) Consortium digital drug development tool 3DT project and the other from the PRO Consortium’s Chronic Heart Failure (CHF) Working Group, which is pursuing qualification of an activity monitor-based endpoint measure by the US Food and Drug Administration’s Clinical Outcome Assessment Qualification Program. Both projects involve industry sponsors willing to collaborate to achieve regulatory endorsement of drug development tools for use in clinical trials. In both cases, individual sponsors were willing to share data from non-interventional observational studies within each consortium in order to accelerate progress toward the collective goal. The session will highlight the challenges and rewards of data sharing within each project, and why sharing of remote monitoring technology data in particular will be crucial to the long-term success of each project. The panelists for this session will include a representative of the Patient-Reported Outcome (PRO) Consortium at C-Path, who will discuss the need for data sharing to advance the effort to qualify an activity monitor-based endpoint measure in chronic heart failure, an industry representative from CPP, and an FDA representative, who will share their perspectives on the promise and the challenges of data sharing in the context of studies involving remote monitoring technologies.