Virtual Clinical Trials: Challenges and Opportunities: A Workshop

November 28 - 29, 2018

Past

Agenda

Materials

About

Workshop Background and Objectives

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 provided a venue to explore 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 remote site visits – for new medical product approval.

The Forum on Drug Discovery, Development, and Translation hosted a public workshop on November 28 - 29, 2018 which featured invited presentations and discussions for stakeholders to:

Explore the current clinical trials infrastructure and highlight opportunities for improvement to support virtual clinical trials, including:
- elements of an IT infrastructure, such as 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.
- potential implications of virtual trials on cost, speed, regulation, and knowledge generation and dissemination of clinical trials; and
Explore potential opportunities to use digital health tools to improve participation in trials, 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.

Below are materials for the workshop, including an agenda, bios of speakers, a sampling of virtual clinical trials (as of the workshop), and presentations. View archived webcast footage of the presentations and discussions here.

For additional information on the workshop, including the planning committee and sponsors, please visit our project page.

Contact

Forum Staff

drugforum@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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Virtual Clinical Trials: Challenges and Opportunities: A Workshop

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Virtual Clinical Trials: Challenges and Opportunities: A Workshop