In the Spotlight: 2022 Annual Report
We are delighted to present the MRCT Center Impact Report 2022. This web-based, interactive resource includes our current projects and recent guidance. Thank you for your continued support as we work collectively to promote global clinical trials.
Advancing International Clinical Research Webinar Series
The fifth and final conference in the FDA-supported webinar series, “Promoting Global Clinical Research in Children: Informing the Future,” is scheduled for March 21, 2023, from 9:00 AM – 11:00 AM EDT. This event will showcase select resources and materials from the larger body of work created, and the four webinars held, throughout the work of the MRCT Center pediatric working group initiative.
Click here to register.
On November 29 & 30, 2022, the MRCT Center, supported in part by the FDA, hosted a virtual conference entitled “Advancing International Pediatric Clinical Research: Facilitating Pediatric Medicines Development: Models of Global Cooperation” that built on existing models of global regulatory cooperation to strengthen the international regulatory ecosystem for pediatric clinical trials.
Click here to view the webinar resources.
Joint Task Force for Clinical Trial Competency
We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Thai.
Click here to view.
Other available translations: English, Spanish, French, and Japanese.
The JTF held a global strategic meeting in November 2022 that included international JTF activity updates and an introduction to two new initiatives: (1) a Data Management and Informatics Task Force and (2) efforts to establish validated assessments of clinical research competencies.
Click here for the Executive Summaries and Conference Slides. If you are interested in contributing to the new initiatives, please contact Carmen Aldinger.
New Chinese Modules released for ICH Efficacy Guidelines
Three years ago, the MRCT Center created an online training course entitled, “Interpretation and Application of ICH E6(R2).” Recently, PATH translated several modules into Chinese. These modules are now available.
Click here to view the Chinese modules.
This Month at the MRCT Center
The MRCT Center is delighted to announce that Dr. Barbara Bierer, MRCT Center Faculty Director, and several team members–Dr. Nora Hutchinson, Lisa Koppelman, and Lauren Otterman–are currently in Switzerland to host a 2-day conference, “Aligning Stakeholders to Facilitate Pediatric Access to Medicines: From Product Development through HTA Review,” held at the Fondation Brocher. Supported in part by an award from the Fondation, 26 representatives of academia, industry, patients and patient advocacy groups, regulators, bioethicists, and statisticians from Europe, the UK, the US, and Canada will address existing barriers and potential opportunities to improve the efficiency of pediatric drug development and access to medicines.
On January 30 and January 31, 2023, Dr. Bierer is co-chairing the National Academies of Sciences, Engineering, and Medicine’s Committee on Science, Technology, and Law virtual workshop: “The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals.” The event is free and open to the public. For more information and to register, click here.
Dr. Willyanne DeCormier Plosky will present at the BIO’s Clinical Trial Diversity Roundtable on January 31. The session’s title is “Analyzing the Data We Have Today, Enhancing Data Sources and Infrastructure for the Future, and Building a Diverse Workforce.”
PUBLICATIONS
January 4, 2023: Members of the MRCT Center, including Senior Advisor Dr. Luke Gelinas, and Drs. Deborah Zarin and Barbara Bierer, published an empirical study, “Ensuring the Scientific Value and Feasibility of Clinical Trials: A Qualitative Interview Study,” to elucidate current practice and identify areas of need concerning the scientific value and feasibility of planned and ongoing clinical trials in the American Journal of Bioethics (AJOB) Empirical Bioethics.
Learn More.
December 20, 2022: Dr. Barbara Bierer submitted comments on behalf of the MRCT Center to the FDA regarding “Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Guidance for Industry, Sponsors, and IRBs.
Learn More.
December 7, 2022: MRCT Center Senior Advisors Drs. Luke Gelinas and David Strauss, with Dr. Barbara Bierer, co-authored an article on “Protecting the Vulnerable And Including the Under-Represented: IRB Practices and Attitudes” published in the Journal of Empirical Research on Human Research Ethics. It examines the role of IRBs in ensuring representativeness in clinical research while protecting vulnerable populations.
Learn More.
October 2022: MRCT Center’s Dr. Bierer and Sylvia Baedorf Kassis co-authored an article entitled “Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol,” which was published in Contemporary Clinical Trials. The article presents the details of a randomized acupuncture intervention protocol conducted in the US, South Korea, and China.
Learn More.
Sponsor News and Events
Bioethics Collaborative: Next Meeting – February 2, 2023
The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials.
The next meeting on February 2, 2023, will explore ethical obligations to plan for emergencies, including wars, natural disasters, and public health crises, in advance. Experts from industry and academia will share their perspectives, leaning on firsthand experience. The ethics of emergency preparedness in clinical research is an under-explored topic, and we look forward to a lively discussion. A meeting summary will be made available to Sponsors through the Bioethics Collaborative page on our website.
Research, Development, and Regulatory Roundtable (R3): Next Meeting – March 2, 2023
Initiated in 2018 with our partners Ropes & Gray LLP, the Research, Development, and Regulatory Roundtable (R3) fosters discussion among policymakers, legal counsels, academicians, industry representatives, and global regulators.
The next meeting on March 2, 2023, “FDA’s Clinical Decision Support Software Final Guidance & Clinical Trial-Related Provisions of the Food and Drug Omnibus Reform Act of 2022,” will cover two topics: (1) an overview of the FDA’s recent final guidance on clinical decision support (“CDS”) software, with a focus on its application to clinical research settings, and (2) the provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization.
The most recent meeting on December 13, 2022, revisited the impact of international privacy laws on research, including recent changes in the European Union’s General Data Protection Regulation (“GDPR”). The meeting consisted of a series of expert panels that addressed challenges to research presented by data privacy regulations under the GDPR and other geographies, such as the Personal Information Protection Law of the People’s Republic of China (“PIPL”). Francis Collins, M.D., Ph.D., Special Advisor to President Biden for Special Projects and former director of the National Institutes of Health, delivered a keynote address to the over 100 guests in attendance across the globe.
To learn more about Sponsorship, click here.
MRCT Center Updates
The MRCT Center welcomes:
Samjhana Bogati, Program Manager
Samjhana is focusing on capacity-building and training related to the design and conduct of clinical trials for a global audience, as well as leading a project assessing and resolving common barriers in clinical trials.