Quality & Transparency Archives

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

Deliverables

Projects

July 30, 2018 @ 8:30 am – 4:00 pm

Boston, MA

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.

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Projects

MRCT Center Annual Meeting

December 5, 2018 @ 8:00 am – 5:00 pm

Loeb House at Harvard University, Cambridge, MA

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:

European Union General Data Protection Regulation (GDPR)
Representation of Diverse Populations
Advancing the Study of Clinical Trials
Capacity Building
Health Literacy in Clinical Research.

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.

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PRIM&R’s 2018 Advancing Ethical Research Conference

November 15, 2018 @ 8:00 am – 5:00 pm

San Diego, CA

Sarah White, MRCT Center Executive Director, will co-present (1) ClinicalTrials.gov: How Academic Institutions Can Respond to New Clinical Trial Disclosure Requirements and (2) Ideas and Practices for for Compliance and Auditing of Single IRB Studies at the Advancing Ethical Research Conference.

Find more information on the conference here

Deliverables

Projects

Breakfast Roundtable Discussion Regarding GDPR and Clinical Research with Paul Mills from the UK’s NHS Health Research Authority

January 7, 2019 @ 9:30 am – 11:00 am

Ropes & Gray LLP, San Francisco, CA

Ropes & Gray and the MRCT Center will be co-hosting a breakfast roundtable discussion regarding the impact of GDPR on clinical research with Paul Mills from the United Kingdom’s National Health Service Health Research Authority on Monday, January 7, 2019 from 9:30 a.m.-11:00 a.m. at the Ropes & Gray office in San Francisco.

Dr. Mills, who is an official within the United Kingdom’s primary human research and clinical trials regulatory agency, has been working for the past nine months in advising commercial and non-commercial sponsors of research on approaches to take in implementing GDPR in research across the United Kingdom. As part of this process, he has reviewed the transparency language of approximately 170 research sponsors from around the globe and has helped to implement processes to minimize any disruption imposed by GDPR on the conduct of health research in the United Kingdom.

Dr. Mills has agreed to address questions from attendees during the roundtable. Please send questions in advance to David Peloquin (david.peloquin@ropesgray.com) and Leslie Thornton (leslie.thornton@ropesgray.com), the two Ropes & Gray attorneys who will be moderating the roundtable. We expect a frank and engaging discussion.

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Presentations at AAHRPP Conference

May 22, 2019 @ 7:00 am – 6:30 pm

The Ritz Carlton, New Orleans

Dr. Barbara Bierer, MRCT Center Faculty Director, will co-present in two sessions at the 2019 AAHRPP Annual Conference:
May 22, 2019, 10:30-11:45 AM: GDPR: Considerations for Implementation
May 23, 2019, 2:15-3:30 PM: Is There a Right Not to Know Your Genetic Data? Panel Discussion

For more information, click here.

Deliverables

Projects

Launch of Proactive Safety Surveillance Project

May 3, 2019 @ 8:30 am – 4:30 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

As the official launch to the project, on May 3, 2019, the MRCT Center invited over 40 representatives from industry, academia, government, and patient advocacy groups to discuss a vision for aglobal, cooperative model of a more proactive, predictive safety surveillance system than exists today.Dr. Robert Califf, former Commissioner of FDA, delivered the opening keynote entitled, ‘New Possibilities for Medical Product Safety in the Digital Revolution.’ The conversation that followed was expansive, thought-provoking, and dynamic. Diverse perspectives on many topics were considered, including the sources, curation, and use of data; the importance of understanding the benefit to risk and not simply a safety risk; communication of the balance of benefit and risk to patients; and communication between stakeholders, regulators, and the global population. The MRCT Center will continue to explore the themes identified during the meeting to develop a concrete plan for the future.

Deliverables

Projects

Credit for Data Sharing Webinar

November 12, 2019 @ 11:00 am – 12:00 pm

Virtual Event

Vivli, the Multi-Regional Clinical Trials Center (MRCT Center) and Association of American Medical Colleges (AAMC) present a discussion on methodologies for appropriating credit in data sharing.

Dr. Barbara Bierer, MRCT Center Faculty Director, is one of the presenters. The webinar will be held Tuesday, November 12th at 11 AM EST.