Dr. Barbara Bierer, MRCT Center Faculty Director, will be speaking on “Improving the Performance of Clinical Trial for Global Directives” at the Global Clinical Research Summit in Seoul on September 7th. Learn more
Convening representatives from academia, industry, and government, this conference explored the impact of the EU GDPR on human subjects research, highlighting the challenges posed by the GDPR to clinical research, biobanking and databanking, and big data research, particularly in light of the limited guidance available to date from EU and EU member state authorities.
Released on: July 30, 2018
Topic: Application of the General Data Protection Regulation (GDPR) to Research: Legal, Practical and Strategic Implications
October 2021: Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data
September 2021: Comments on European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers
October 2020: How to Fix the GDPR’s Frustration of Global Biomedical Research
April 2020: Comments to the European Commission on the Challenges that GDPR Raises for Research
March 2020: Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data
February 2019: Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered
January 2019: Letter to the European Data Protection Board on the Board’s November 2018 Draft Guidance on the Territorial Scope of the GDPR
July 2018: Impact of GDPR on Clinical Research
Attendees discussed the advantages and drawbacks of the two pathways by which patients may now request access to investigational therapies. Among other things, we considered the impact of each avenue on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies, considering the perspectives of both pharmaceutical companies and large academic healthcare facilities.
Released on: November 8, 2018
Topic: Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
This meeting of the MRCT Center Bioethics Collaborative will explore the ethical considerations underscoring the challenge of informed selection of clinical trials. We will examine the responsibilities of various stakeholders within the clinical trial ecosystem, and we will discuss potential solutions.
The current landscape of clinical trial identification, referral, selection, and enrollment depends largely upon access to clinical trial information by a multiplicity of stakeholders. Unfortunately, access to this information is fragmented. Treating physicians do not routinely discuss clinical trials with their patients; investigators recommend enrollment in the clinical trials in which they or their institution are involved, but often not others; institutional IRBs evaluate the potential benefit/risk calculus for a given trial without consideration of the entire landscape of competitive trials; institutions do not consistently provide patients with instructions or guidance on navigating patient advocacy and trial registry websites, nor do they refer patients to external resources (e.g., patient advocacy groups and disease advocacy organizations) to help navigate the choice among alternative trials; existing clinical trial databases are often incomplete and complex, and they do not convey information in ways that help patients and providers choose among available trials. As a result, patients’ knowledge of their clinical trial options is often incomplete, and enrollment decisions are based on limited information.
Patients can, and often want to, be empowered with clinical trial information that is understandable and accessible. But institutional walls appear to have created artificial boundaries around the choice of clinical trials. We have not equipped patients to compare the suitability of the clinical trial(s) offered by their physicians with those offered down the block or across the river, concordant with their own preferences. As availability of electronic information increases (and with the appreciation that more information is not necessarily better information), our current systems may be improved to better uphold the foundational ethical principles of clinical research. These principles—respect for persons, beneficence, and justice—and their application to how we offer, and how patients select, clinical trials deserve review.
Barbara Bierer, MD, MRCT Faculty Director will participate in a panel discussion on APEC regulatory convergence at the BIO 2018 conference in Boston, MA.
Dr. Barbara Bierer, MRCT Center Faculty Director, and Mr. Mark Barnes, MRCT Center Faculty Co-Director, will co-host a conference with the Organisation of Pharmaceutical Producers of India (OPPI) at their offices on clinical trials regulatory issues.
Topic: Ethical Challenges of Phase 1 Clinical Trials.
Dr. Barbara E. Bierer, MRCT Center Faculty Director, will be a commentator at the Harvard Medical School Center for Bioethics’ September Research Ethics Consortium.
Click here to register to attend.
The official launch of the Vivli platform will take place at the National Academies in Washington D.C. on July 19, 2018.
MRCT Center Faculty Director and Vivli co-founder, Barbara Bierer, MD, will moderate the panel discussion, Moving the Needle: How to Shift the Culture on Data Sharing.
Find more information about the launch here
Ropes & Gray LLP and the MRCT Center will co-host a one-day conference focusing on the effect of the European Union General Data Protection Regulations on clinical research, big data research and data repositories/ biorepositories.
Conference attendance is limited to MRCT Center Sponsors and invited guests. The conference will take place in Boston, MA on July 30, 2018.
The MRCT Center Annual Meeting was held in the morning of December 5, 2018 (8:00 AM -1:00 PM).
The keynote speaker was Guido Rasi, Executive Director of the European Medicines Agency (EMA).
Click here to view the Annual Meeting Agenda.
Click here to view the Annual Meeting Proceedings
Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2018 Annual Meeting were:
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
