Clinical trials are a cornerstone of medical product development-- supporting the evaluation of efficacy and identification of safety issues of new drugs-- and a necessary regulatory requirement for bringing novel therapies to market. This workshop will examine opportunities for a modern, patient-centric clinical trials enterprise in light of digital health tools that could allow virtual clinical trials (e.g., studies that deploy various digital health tools or virtual site visits) for new medical product approval.
Participants will discuss the current state of the clinical trials enterprise; highlight opportunities for systemic improvements; and discuss mechanisms to facilitate participation in clinical trials, including enhanced collaboration among sponsors, researchers, regulators, patients, providers, and health systems.
Subject matter experts will be invited to participate in the workshop through presentations and discussions that will:
Highlight opportunities for systemic improvement to support virtual clinical trials, including:

• potential implications of virtual trials for cost, speed, regulation, and knowledge generation and dissemination of clinical trials; and
  
• elements of an IT infrastructure, including integrating data from electronic health records, mobile health applications, remote monitoring, virtual visits, and other relevant technologies with the capability to enhance the interface between clinicians and clinical trial participants.

Explore potential opportunities to use digital health tools to engage with patients and potential research participants, facilitate recruitment of participants to join a clinical trial, and maintain participation of diverse populations in the trial, including:

• collaborative approaches and incentives involving sponsors, researchers, patient advocacy groups, patients living with the particular condition being studied, and health systems—including regulations, quality measures and outcomes, or reimbursement strategies-- to support the implementation of virtual clinical trials; and
  
• opportunities and challenges to enhancing equity in access and participation through virtual clinical trials.

The planning committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A workshop proceedings will be prepared by a designated rapporteur based on the information gathered and discussions held during the workshop in accordance with institutional policies and procedures.