Comments Submitted: Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics

Public Comment

Submitted on: February 4, 2025

Submitted to: Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration

The MRCT Center submitted public comments in response to FDA’s draft guidance on the accelerated approval program, suggesting areas needing further clarification such as the identification and validation of surrogate endpoints, the rigor and timeliness of confirmatory trials, expansion of public disclosures for regulatory actions, increased transparency regarding decision-making and withdrawal, and global considerations in the absence of international harmonization of these regulations. 

Opportunities to Engage and Retain Talent in the Clinical Research Workforce

Webinar workshop

February 25, 2025 @ 10:00 am 12:30 pm

The Convergence Project is pleased to invite you to an upcoming virtual event hosted by the MRCT Center, focused on workforce development strategies to support a more dynamic and competitive clinical research workforce.

This meeting will bring together community leaders, policymakers, and researchers to discuss how to create and support pathways into the clinical trial workforce (e.g., part-time degree programs, community colleges, fellowships). Key topics will include workforce development, targeted recruitment, and actionable steps to drive systemic improvements. You’ll have the opportunity to engage with panelists leading programs in Georgia, North Carolina, West Virginia, and other states across the country.

We hope you can join us for this important conversation. We look forward to your participation!

New Developments in Right to Try Legislation

Publication

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.

Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov

Publication

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.

Toward Justice and Community Empowerment in Genomics Studies on Sensitive Traits

Publication

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.

What’s Up with Long-Term Follow-Up: Ethical, Regulatory, & Operational Challenges

Webinar

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.

What’s Up with Long-Term Follow-Up: Ethical, Regulatory, & Operational Challenges webinar recording


Joint Task Force for Clinical Trial Competency (JTF) Global Biannual Meeting

Meeting

May 29, 2025 @ 1:00 pm 3:00 pm

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.

We invite you to attend the next virtual biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) to learn about, present updates, and coordinate ongoing activities with the JTF Framework.

Public Comments submitted: “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice”

Public Comments

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. 

Global Development of a Clinical Research Workforce: Tools and Resources

Webinar

April 3, 2025 @ 9:00 am 10:00 am

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:

  • Utilizing the JTF Framework to define and develop competencies in clinical research
  • Developing the education and training paradigm for the clinical research workforce
  • Recruiting and retaining a diverse and representative clinical research workforce