Published on: January 24, 2025
Published in: Health Law Weekly
Description: A new iteration of the federal Right to Try (RTT) law is gaining momentum. Like the federal RTT law and grounded in similar principles, RTT 2.0 laws sit outside of FDA purview. This article discusses the federal RTT law in comparison to the U.S. Food and Drug Administration (FDA) expanded access pathway, compares RTT with RTT 2.0, and explores the challenges of each.
Published on: January 22, 2025
Published in: Pediatric Research
Description: Analyzing approximately 5000 US pediatric interventional studies registered on ClinicalTrials.gov from 2019 to 2022, 23.4% explicitly included English language requirements in the eligibility criteria and only a small minority provided any justification for the exclusion. Since approximately one-fifth of US households speak a language other than English, this requirement limits access to trials and the generalizability of the research results.
Published on: December 21, 2024
Published in: The Hastings Center Report
Description: The authors provide an overview of past and ongoing efforts in community engagement in genomics studies and consider successes and opportunities for further improvement. They set out a vision for a more equitable and collaborative genomics where wider communities, including social, ethnic, and other communities that share a particular trait, are included in the research as peers and collaborators.
Presented on: December 5, 2024
Presented at: Virtual
This webinar was co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group as a part of their 5th Annual Lunchtime Learning Series. The panel on Long-Term Follow-Up (LTFU) was moderated by Dr. Carolyn Chapman and captured the ethical, regulatory, and operational challenges of LTFU studies through diverse viewpoints and perspectives.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Join the JTF Biannual Global Meeting on June 2, from 9:00 – 11:00 AM ET, to explore the latest advancements in clinical research workforce development and competency-based training. This session will feature global perspectives on implementing the JTF Framework, including:
All registrants will receive slides and a meeting summary after the meeting.
Comments provided on: December 13, 2024
Comments provided to: U.S. Food and Drug Administration
Description: The FDA draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice,” (FDA-2024-D-2052) highlights the need for maintaining scientific rigor and data reliability when using real world data (RWD) amidst diverse healthcare settings. The MRCT Center comments addressed data quality when using clinical (and variable) data, ethical and practical challenges of randomization in clinical settings, vulnerabilities in data privacy and security, and participant safety while promoting innovative approaches and pilot programs to refine implementation strategies for this purpose.
Join us on April 3 from 9 – 10 am ET for a webinar dedicated to Global Workforce Development: Tools and Resources, featuring a keynote by Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS). Dr. Rago will share insights on CIOMS initiatives to define and synthesize professional competencies essential for clinical research and the need for cooperative agreements to harmonize workforce development efforts.
The session will also highlight the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundational tool for training and professional development, addressing the challenges and opportunities of recruiting and retaining a diverse and capable workforce.
Sally Armstrong, CEO of PRAXIS Australia, will share how PRAXIS Australia has used the JTF Framework in their educational offerings, including courses, workshops, and immersive onsite training programs.
Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), will discuss ACRP’s “Partners Advancing the Clinical Research Workforce,” an initiative aimed at building a diverse and qualified clinical research workforce through training programs, educational resources, and collaborations with industry leaders, based on the JTF Framework, to address the needs of the clinical research field by providing pathways for new entrants and career advancement for existing professionals.
This webinar will provide actionable and practical strategies to support global clinical trial professionals.
Key topics:
Topic: TBD
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Topic: TBD
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Location: Virtual
Topic: Medical Need or Market Opportunity: Setting Research Priorities
Abstract: Since funding and other resources for clinical research are limited, decisions must be made about which research projects to pursue, which not to pursue, and how to prioritize among the studies that are chosen. The principle of “unmet medical need” is often acknowledged as a guiding consideration in this context, and there have been calls for community input into prioritization and the choice of the study question. Further, addressing unmet medical needs, particularly in the context of the global burden of disease, is important for public health but may not, and likely will not, maximize market opportunity or financial profits – a dynamic that is particularly salient for private industry sponsors. Should prioritization then rest solely or principally with the funder? How should such entities balance economic obligations toward shareholders with the public good?
One salient principle of distributive justice is “prioritarianism,” the idea that research that stands to benefit the worse-off or those who are already underprivileged should be given priority over research that stands to benefit people in better situations: the well-being of the most disadvantaged is prioritized. Even prior to this, however, questions arise over how to understand the expected goods of research, who the beneficiaries might be, and how the well-being of different possible beneficiary groups should be measured. Further downstream, issues arise over who should engage in prioritization decisions, and in particular, whether the research community should rely solely on high-level, centralized prioritization mechanisms (e.g., industry sponsors, NIH, non-profit funders), or whether individual institutions, local communities, and/or patients and their allies might have some role to play in ensuring that studies are appropriately prioritized at a local level. How should these various voices be heard, should they be represented, and how can—or should—balance be achieved, and if so, what processes should be considered? The March Bioethics Collaborative will seek to address these and other issues in connection with the ethics of research priority-setting.
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
