The third Research, Development, and Regulatory Roundtable (R3) was held at the Washington, D.C. offices of Ropes & Gray LLP on March 7, 2019. Stakeholders convened to discuss Secondary Uses of Health Care Data for Clinical Trial Recruitment: Legal and Regulatory Ambiguity. Afterward, attendees were updated on developments related to the application of the EU General Data Protection Regulation (GDPR) to research.
The use for clinical trial recruitment purposes of data that were originally collected for another business purpose raises several legal and regulatory questions, including whether the companies have authority to use health care data for these secondary purposes; whether health care providers may receive payment for permitting secondary uses of their data or for the results of these secondary use; the extent to which third-party payors, or agents of those payors, may be involved in research recruitment; and which entities may contact patients directly to discuss possible enrollment in a clinical trial. During this session, roundtable participants discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.