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.

Engaging children and adolescents in the design and conduct of paediatric research

Publication

Published on: November 11, 2024

Published in: Frontiers in Pediatrics

Description: A recent Frontiers in Pediatrics article, co-authored by Barbara Bierer and Elisa Koppelman of the MRCT Center, emphasizes the importance of directly involving children and adolescents in pediatric research design and execution, highlighting the benefits of incorporating their perspectives alongside those of parents and guardians. The authors provide theoretical, ethical, and practical recommendations for systematically engaging young participants to enhance the relevance and effectiveness of clinical studies.

Towards A National Action Plan To Improve Representation In Clinical Trials

Publication

Published on: November 6, 2024

Published in: Health Affairs

Description: In the Health Affairs article “Towards A National Action Plan To Improve Representation In Clinical Trials,” co-authored by the MRCT Center’s Barbara Bierer, the authors address the critical need for increased diversity in clinical research to enhance health outcomes for underrepresented populations. They propose a comprehensive national strategy that includes policy reforms, community engagement, and the integration of diverse perspectives in trial design and implementation.

Creating educational materials about clinical research data for patients and the public

Publication

Published on: September 2024

Published in: Medical Writing

The article discusses the importance of creating educational materials to improve public understanding of clinical research data, particularly in light of misinformation during the COVID-19 pandemic. It emphasizes the need for transparency and clarity in addressing issues like data privacy and the ethical sharing of information. Modern tools such as videos and infographics can make clinical research more accessible and build trust with patients and the public. 

The PubPeer conundrum: Administrative challenges in research misconduct proceedings

Publication

Published on: August 13, 2024

Published in: Accountability in Research

Description: Mark Barnes and colleagues at Ropes & Gray, and Barbara Bierer published an article that discusses the impact of PubPeer, an online platform that publicizes suspected data integrity concerns, on the research misconduct process and the institutional challenges of handling anonymous comments within current regulations. The authors propose processes to ensure that credible allegations are rigorously assessed while reducing burden on institutions tasked with their investigation.