February 2023

IN THE SPOTLIGHT

The MRCT Center is delighted to announce our upcoming webinar, "Promoting Global Clinical Research in Children: Informing the Future," the fifth and final part of the FDA-supported virtual conference series on FDA-supported virtual conference series on Advancing International Pediatric Clinical Research. This event will showcase select resources and materials developed by the MRCT Center pediatric working group initiative, including highlights from the four prior webinars in this series.

March 21: 9:00 AM – 11:00 AM EDT

Click here to register.

For more information about the MRCT Center’s work to promote global clinical research in children, click here.

Annual Meeting Proceedings and Slides

Proceedings and slides have been posted from the MRCT Center Annual Meeting in December 2022. The meeting included a fireside chat with Dr. Kenneth Frazier, retired Chairman and CEO of Merck, and panel discussions on expanding the footprint of clinical trials as well as the ethical and regulatory basis for secondary research uses of biospecimens.

To view these resources, click here.

Events & Presentations

March 2: 1 PM – 3:30 PM EST

Research, Development, & Regulatory Roundtable (R3): open to R3 Sponsors

The first topic will be presented by Ropes & Gray LLP partner Kellie Combs, who practices in the firm’s Life Science Regulatory and Compliance practice group and is a co-lead of the firm’s cross-practice digital health initiative. She will provide an overview of FDA’s 2022 final guidance on clinical decision support (“CDS”) software. Algorithms used in clinical trials may be regulated as CDS, and the CDS framework also has a complex overlay with the laboratory-developed test (“LDT”) framework that has been discussed at past R3 meetings.

The second topic, presented by Ropes & Gray partner and MRCT Center Senior Advisor David Peloquin, will address sections of Food and Drug Omnibus Reform Act of 2022 (“FDORA”) that are relevant to clinical researchers. This includes requirements for certain clinical trial sponsors to file diversity action plans, provisions intended to clarify and advance the use of decentralized clinical studies, provisions intended to clarify the use of digital health technologies in clinical trials, and recommendations on the use of other innovative trial designs.

To learn more about the Research, Development, & Regulatory Roundtable (R3), click here.

March 3: 12:30 PM – 3:30 PM Japan/11:30-2:30 Singapore

Virtual Asia Pacific Open Forum

Join MRCT Faculty Co-Director Mark Barnes and the Science Policy Think Tank for an open forum and virtual discussion about the international governance of sharing of and access to biospecimens and associated data. The forum is timed for an Asia-Pacific audience. Spread the word!

For more information about the event, click here.

To register, click here.

March 21: 9:00 – 11:00 EDT

Join us for the fifth and final part of the FDA-supported virtual conference series on Advancing International Pediatric Research: “Promoting Global Clinical Research in Children: Informing the Future.” (See Spotlight above.)

Click here to register.

March 30: 12:30 - 1:40 PM EDT

MRCT Center Acting Program Director Dr. Willyanne DeCormier Plosky will speak on “Study Design and Site Selection: MRCT Diversity Guidance Toolkit” at the NIH Workshop on Inclusive Participation in Clinical Research.

Click here for more information about the workshop and to register.

To download and learn more about the MRCT Center’s “Achieving Diversity, Inclusion, and Equity In Clinical Research” toolkit, click here.

Update from the Brocher Conference in January

We are delighted to share that the conference, “Aligning Stakeholders to Facilitate Pediatric Access to Medicines: From Product Development through HTA Review,” held at the Fondation Brocher in Hermance, Switzerland was a great success! 26 representatives from academia, industry, patients and patient advocacy groups, regulators, and bioethicists from Europe, the UK, Canada, and the US convened for two intensive days of discussion to address existing barriers and potential opportunities to improve the efficiency of pediatric drug development and access to medicines. A summary of the meeting and proposed next steps to advance this work will be forthcoming.

Photo: Lauren Otterman, Elisa Koppelman, Dr. Barbara Bierer, and Dr. Nora Hutchinson

Publications

January 28, 2023: Elisa Koppelman, Dr. Barbara Bierer, Dr. Steven Joffe and others co-authored an article, “Establishing a global regulatory ﬂoor for children’s decisions about participation in clinical research” that offered recommendations to clarify the International Council for Harmonization ICH-E11 guidelines, recommendations that would serve to promote a common ethical platform for conducting global pediatric research in Pediatric Research.

Learn More.

MRCT Center Updates

We welcome new Executive and Steering Committee sponsors!

Gilead joined the Executive Committee in late 2022.

Gilead Sciences, Inc. is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. Learn more about Gilead here.

Two organizations have joined the Steering Committee:

PPD, part of Thermo Fisher Scientific, clinical development and analytical services enable customers to accelerate innovation and increase drug development productivity. Learn more about PPD here.

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. Learn more about Syneos Heath here.

Learn more about MRCT Center sponsors.

Learn more about becoming an MRCT Center sponsor.

Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

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