In the Spotlight
Celebrating Dr. Bierer’s Leadership in Research Advocacy
Dr. Barbara Bierer, Faculty Director of the MRCT Center and Professor of Medicine at Harvard Medical School, will receive the Herbert Pardes Family Award for National Leadership in Advocacy for Research at the 2025 Research!America Advocacy Awards on March 12 at the National Academy of Sciences in Washington, D.C.
Click here to read more about the 2025 Research!America Advocacy Awards and Dr. Bierer’s fellow honorees.
Data Literacy in Clinical Research: Enhancing Trust and Transparency
A key aspect of health literacy—especially in clinical research—is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions.
The MRCT Center, in collaboration with PHUSE, has developed a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context. Join us for this webinar on April 3 from 10 – 11 AM ET as we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community.
Key Topics:
- Advancing Data Literacy as a Component of Health Literacy
- Applying Plain Language and Visual Tools to Data Communication
- Empowering Participants with Transparent and Actionable Information.
Webinar: Global Development of a Clinical Research Workforce: Tools and Resources
Join us on April 3 from 9 – 10 AM ET for a webinar dedicated to Global Workforce Development: Tools and Resources, featuring the keynote speaker Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS). We then 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 courses, workshops, and immersive onsite training programs.
Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), will discuss ACRP’s initiatives to build a diverse and qualified clinical research workforce through training, education, and collaboration, based on the JTF Framework. This webinar will provide actionable and practical strategies to support global clinical trial professionals.
The MRCT Center works to improve the integrity, safety, and rigor of global clinical research by shaping policies that foster ethical, responsible, and accessible research practices. Contributing to policy engagement and public dissemination by submitting public commentary on regulatory proposals, draft guidance, and policies ensures that evolving frameworks, guidelines, and rules reflect the needs of research participants, sponsors, investigators, and the broader scientific community. Our ongoing engagement demonstrates our dedication to strengthening research integrity through thoughtful feedback on evolving regulations, promoting participant protection and ethical considerations, and encouraging innovation and practical implementation.
Since January 2024, we have submitted 27 public comments, shaping policies and practices that impact sponsors, researchers, and participants worldwide. These contributions help ensure that research remains rigorous, responsible, and accessible.
Examples of Our Recent Public Comments:
- Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics (February 4, 2025): We suggested clarifications on surrogate endpoint validation, confirmatory trial rigor, expanded public disclosures, decision-making transparency, and global considerations in the absence of international harmonization.
- Ethical Guidelines for Research Using Pervasive Data (January 15, 2025): We advocated for enhanced safeguards through expanded legislative protections, increased transparency, continuous ethical oversight, and periodic review of data practices to address advancements and mitigate risks to individuals and communities.
- Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice (December 13, 2024): Our comments focused on data quality when using clinical 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.
- Proposed Rule: Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons (November 29, 2024): We emphasized the need to balance security measures with global health priorities, recommending explicit public health and research exemptions, alignment with international standards, refined definitions, and transparent compliance to support access to health-related data and the advancement of science, medicine, and individual and public health.
Click here to explore all the MRCT Center’s Public Comments.
Events & Presentations
January 16: Barbara Bierer, MRCT Center Faculty Director, was an invited speaker and participant at the European Open Science Cloud (EOSC)-European Network of TRUSTed research environments workshop, hosted by ECRIN. She spoke on “Support of IPD meta-analyses through trusted research environments (TREs)” during the global webinar.
January-February 2025: Mark Barnes, MRCT Center Faculty Co-director and Partner, Ropes & Gray, Ropes & Gray colleagues, and Barbara Bierer, presented three webinars addressing early actions of the Trump administration that impact research:
- February 9: “NIH Caps Indirect Costs at Flat Rate: Critical Implications for Research Institutions
- January 29: “The Trump Administration’s DEI-Related Executive Orders: Implications for Federal Funding”
- February 5: “Pressures on Research Funding under the Trump Administration: Indirect Cost Recovery and other Restrictions”
February 12-13: Hosted by the WHO and ETH Zurich, Barbara Bierer joined colleagues in Zurich, Switzerland, for discussions about the ethics and operational challenges of clinical trials that include decentralized clinical trial elements. The two-day meeting was an initial exploration to inform the development of a future WHO framework and guidance on the topic.
February 19-20: Sylvia Baedorf Kassis presented at OHRP’s Research Community Forum, an in-person event hosted by the Augusta University Institutional Review Board in North Augusta, SC. Sylvia was a co-panelist discussing informed consent guidelines and regulations, and also led a session on designing consent processes with the participant in mind.
February 21: Sylvia Baedorf Kassis joined the Navigating IRB Community Engagement (NICE) team of the Augusta University Institutional Review Board to share and listen at an in-person community forum entitled “Looking Beyond Tuskegee” at the Lucy Craft Laney Museum of Black History.
February 24: Dr. Barbara Bierer presented the first address at Session #1: Setting the Scene of the Lysosomal Storage Disease Data Sharing webinar series, hosted by C-Path’s Critical Path for Lysosomal Diseases in collaboration with the Orphan Disease Center – University of Pennsylvania. She discussed key ethical considerations and policies that shape data sharing in rare disease research, highlighting best practices for responsible and effective data collaboration to advance scientific discovery.
February 25, 10 AM – 1 PM ET: Willyanne DeCormier Plosky, Hayat Ahmed, and Barbara Bierer joined Convergence Project colleagues to present Opportunities to Engage and Retain Talent in Clinical Research: Workforce Development, a workshop hosted by the MRCT Center.
March 5, 11 AM – 12 PM ET: The MRCT Center, in collaboration with the Equitable Access to Clinical Trials (EACT) initiative, hosted by LUNGevity Foundation, invites you to a webinar, Equitable Access to Clinical Trials: Best Practices for Industry. This session will explore best practices for financial support in clinical trials, practical strategies to reduce participant burden, and key considerations for sponsors and Clinical Research Organizations (CROs).
March 10: Meeting of the Bioethics Collaborative. Topic: Medical Need or Market Opportunity: Setting Research Priorities. Click here to learn more about the Bioethics Collaborative.
March 11: Sylvia Baedorf Kassis will be a panelist at the DIA Medical Affairs and Science Communications Forum, speaking on using plain language to develop clear communications about clinical trials. Click here to register.
March 17, 5:00-5:45 PM ET: Willyanne DeCormier Plosky will speak on a panel, “Laying the Foundation for Effective and Equitable Representation in Clinical Trials,” at the Patients as Partners Conference in Boston, MA.
March 24: Sarah White will speak on a panel, “Navigating the Shifting Landscape of Trial Placement and Site Selection for Globally Impactful Oncology Research,” at the Immuno-Oncology 360° (IO360°) program in Boston, MA.
March 27, 11:15-11:45 AM ET: Barbara Bierer will speak on the Declaration of Helsinki at the National Comprehensive Cancer Center (NCCN) IRB Directors Forum in Orlando, Florida.
April 3, 9 – 10 AM ET: Global Development of a Clinical Research Workforce: Tools and Resources. See Spotlight above
April 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: Congressional Investigations into Research Activities and Update on DOJ’s Restrictions on Sharing Bulk Sensitive Personal Data with China and other Countries of Concern. Click here to learn more about the Research, Development, and Regulatory Roundtable (R3)
Publications
February 4: The MRCT Center submitted public comments in response to the 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.
The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.
Learn more about becoming an MRCT Center sponsor.