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 health care providers may receive payment for permitting secondary uses of their data, 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.
The R3 meeting took place on Thursday, March 7, from 10:00am – 3:00pm at the Washington, D.C. offices of Ropes & Gray LLP.
In order to maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden(s) of data sharing, the MRCT Center developed three harmonized governance tools as part of the PCORI Open Science Pilot Project.
The second Research, Development, and Regulatory Roundtable (R3) was held at the New York City offices of Ropes & Gray LLP On November 8, 2018. Stakeholders convened to discuss Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
Roundtable attendees considered the advantages and drawbacks of the two pathways by which patients may request access to investigational therapies.
Among other things, participants explored the impact of each pathway on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies on Right to Try and Expanded Access.
The R3 provides a periodic, non-partisan forum wherein policymakers, regulators, legal counsel, and academicians may present, discuss, and deliberate cutting-edge issues in drug and device development, regulatory oversight of clinical trials, and human subjects research.
For additional information about sponsoring and participating in the R3, please contact the MRCT Center.
Dr, Carmen Aldinger, MRCT Center Administrative and Training Manager, will present on Sharing Aggregate and Individual Results of Clinical Trials with Study Participants.
In collaboration with Ropes & Gray LLP, the MRCT Center hosted a closed, one-day roundtable on Monday, July 30th.
This meeting covered the Application of the General Data Protection Regulation (GDPR) to Research: Legal, Practical and Strategic Implications. Convening over 110 representatives from academia, industry, and government, this roundtable explored the impact of the EU GDPR on human subjects research by highlighting the challenges posed by the GDPR to clinical research, biobanking and data banking, and big data research.
Mr. Mark Barnes, MRCT Center Faculty Co-director, co-authored Will Consent be Disfavored as a Bases for Processing Personal Data in Clinical Research Under EU Data Protection Law? recently published by Bloomberg Law. The article may be accessed by navigating to his bio and scrolling to the bottom of the page for his publications.
This document, which is tailored to sponsors, treating physicians, and Institutional Review Boards/ Research Ethics Committees, includes a set of principles, considerations, and practical tools. It addresses expanded access to investigational products for seriously ill patients who are unable to participate in a clinical study and for whom no equivalent or satisfactory treatment options are available.
