In the Spotlight
Register for the 2023 Annual Meeting
Join us December 13 – 14 in Boston for our 2023 Annual Meeting! The MRCT Center welcomes you to engage in dynamic and stimulating discussions and presentations of our programmatic work. This year, we are enhancing the meeting to a two-day program featuring a keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA); several panel discussions related to our ongoing work; a Research, Development, & Regulatory Roundtable (R3) focusing on (1) privacy laws and (2) data integrity; and a Bioethics Collaborative (BC) forum, discussing ethical issues in gene therapy, all open to registrants at no cost.
Click here for a detailed agenda, the FAQ, and to register. While in-person attendance is encouraged, virtual participation is welcome.
Schedule highlights, in addition to programmatic updates and discussions about MRCT Center work:
- Panel 1: Post-trial Responsibilities: Continued Access to Investigational Products
- Panel 2: International Framework for Specimen Sharing: the Seattle Principles
- Panel 3: Diversity Action Plans and their impact and interpretation through an international and domestic lens
- Research, Development, and Regulatory Roundtable (R3): 1) Update to the GDPR, including discussion of the EU/US data privacy framework; 2) Considerations for Ensuring Accurate Clinical Trials Data
- Bioethics Collaborative (BC): Gene Therapy: Probing the Ethics
Joint Task Force for Clinical Trial Competency (JTF) Biannual Meeting: November 14
The Biannual Global JTF meeting is scheduled for November 14 from 9:00 – 11:00 AM EST. The virtual meeting will include a progress report on the update of the data management and informatics domain, potential amendments to the JTF Framework to accommodate emergency preparedness competencies, utilization of the JTF Framework for workforce development for clinical research, and experience of using the JTF Framework in Canada and Switzerland. There will also be a time for open discussion with meeting participants.
Click here to register.
JTF Framework: Available in Korean
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 Korean. We thank our colleagues and SC sponsors, the Comprehensive and Integrative Medicine Institute (CIMI) and Daegu Catholic University Medical Center for their efforts.
Other available translations: English, Spanish, French, Japanese, Thai, Bahasa Indonesia, Italian, Chinese and Vietnamese.
Click here to learn about the JTF Framework: Domains and Leveled Core Competencies.
Dr. Bierer in Brazil
MRCT Center Faculty Director Barbara Bierer, MD, traveled to Brasilia, Brazil, to participate in a regional workshop organized by the Pan American Health Organization (PAHO). Key regulatory authorities, research ethics leadership, industry, CROs, and investigators from different countries of the Region of the Americas met to identify, discuss, and propose concrete actions to strengthen scientifically and ethically sound clinical trials in the region. In addition, the meeting helped to inform the 75th World Health Assembly resolution WHA 75.8.
Health Literacy Month Spotlight
Thinking about Numeracy
When crafting patient-facing materials, focusing on health literacy best practices such as plain language, intuitive design, cultural awareness, and usability testing are expected. Numeracy and the clear presentation of numeric data demand additional attention.
In clinical research, understanding risk, percentages, probabilities …
Data Literacy: Leveraging PHUSE Videos to Advance Understanding
Participants’ understanding of how their data are collected and used in research is important for empowering value-concordant decision-making. The MRCT Center is actively focused on developing educational materials for the public to understand the concept, importance, use of, and protections for data in clinical trials to complement the exemplary PHUSE Global Healthcare Data Science Community video series on data privacy and data-sharing. This work expands our ongoing commitment to improve health literacy. We welcome additional collaborators to the data literacy initiative.
Health Literacy On-Demand Webinar: Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials
A recent health literacy webinar focused on best practice strategies to incorporate patient perspectives in crafting participant-facing materials that are accessible, culturally competent, and easy to understand.
Click here to view the webinar resources, including the recording, slides, and related materials.
Events & Presentations
November 3: Dr. Bierer will discuss “Ethical Review of Decentralized Clinical Trials” at the two-day “Human Research Protection: Unstoppable” conference hosted by Cincinnati Children’s, the University of Kentucky (UK), University of Cincinnati (UC), and Northern Kentucky University (NKU).
November 6: The third Diversity Convergence Meeting will take place on November 6, during the Future of Health Summit: November 6-8. This invite-only meeting is expected to be policy-oriented and follows upon the first meeting hosted by CTTI in June and the second meeting hosted by the MRCT Center in September. FasterCures, a center of the Milken Institute, will host the third meeting, send invitations, and provide further communication.
November 6: Dr. Bierer will speak on “Health Equity Convergence across the Biomedical Research Ecosystem” at a Roundtable Discussion during the Future of Health Summit: November 6-8.
November 9 – 11: Dr. Bierer will attend the CIMI conference in Daegu, Korea, presenting on “Scaling Decentralized and Hybrid Clinical Trials to Decrease Participant Burden: Opportunities and Limitations.”
November 13: Dr. Bierer is presenting on “Ethical challenges in clinical research during a pandemic”at the2023 NIH-sponsored Advanced Training Course entitled, “Frontiers in Emerging, Re-Emerging, and Zoonotic Diseases and Diversity (FrERZD2)” at the Ponce Health Sciences University, Ponce, PR.
November 13, 1:30 – 4 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070. Open to R3 Sponsors.
November 16: Dr. Bierer is presenting on “CREDIT and incentivizing the academic culture” at the Vivli Annual Meeting, “Shaping the next 10 years in Data Sharing: Building on the gains made in the past 10 years in advancing human health and looking ahead to the next 10 years,” to be held at NASEM in Washington DC.
November 14: Dr. Carolyn Chapman will be presenting on “Protection of human research participants” at the American Association for Cancer Research (AACR) Translational Cancer Research for Basic Scientists Workshop.
November 17: Dr. Bierer is presenting on the “Role of IRBs in improving the inclusion of sex and gender as variables in clinical research” at the “Sex and Gender Reporting in Musculoskeletal Research Symposium” organized by the Journal of Bone and Joint Surgery and Dr. Kim Templeton, KUMC, and held in Boston, MA.
November 29: Dr. DeCormier Plosky will be participating on a panel, “Approaches to Support the Inclusion and Clinical Study Participation of Individuals with Disabilities Including Intellectual or Developmental Disabilities,” as part of the FDA/CTTI Public Workshop to Enhance Clinical Study Diversity that will be held virtually November 29-30.
November 30: Dr. Bierer will participate on the panel, “Post-Approval Dissemination of Clinical Study Enrollment Demographic Data to the Public” at the same virtual FDA/CTTI Public Workshop to Enhance Clinical Study Diversity meeting.
December 4 – 6: The MRCT Center at the PRIM&R Annual Conference:
December 4:
- Dr. Bierer: “What Keeps You Up at Night: Future Frontiers in Research”; “IRB Review of Technology Used for Virtual and Virtual/Remote Clinical Trials”
- Sylvia Baedorf Kassis: “Supporting Informed Decision Making: How to Foster the Development of Understandable Research-Related Information”
- Elisa Koppelman: “Including Young People in Research: A Toolkit to Support the Intentional Inclusion of Youth Perspectives in Pediatric Clinical Trials & Product Development”
December 5:
- Dr. DeCormier Plosky: “It’s About Time: Inclusion of Sexual and Gender Minorities in Clinical Research”; “Accessibility by Design: Operationalizing Full Commitment to the Americans with Disabilities Act in Clinical Research Practice”
December 6:
- Dr. Bierer: “Utilizing a System of IRB Precedent: Moving Toward Consistency and Transparency”
December 13 – 14: The MRCT Center Annual Meeting, including meetings of the Research, Development, and Regulatory Roundtable (R3) and Bioethics Collaborative (BC). Open to all registrants at no cost. (See Spotlight above; click here for more information and to register.)
Publications
September 30: The MRCT Center submitted comments in response to the NIH Request for Information (RFI): Inviting Comments and Suggestions on Updating the NIH Mission Statement (NOT-OD-23-163). We wish to commend the NIH for recognizing people with disabilities as a population with health disparities. We also fully endorse the proposed changes to the NIH mission statement and the elimination of the reference to “reduc[ing] illness and disability,” a statement that is ableist and discriminatory. The proposed mission statement is a welcome alignment with the vision and purpose of the agency.
October 1: Barbara Bierer, Deborah Zarin, and Luke Gelinas published “Deprioritization of Ongoing Clinical Trials” to describe the importance of, ethical imperative in, and approaches for ensuring that clinical trials continue to be scientifically relevant and of value once initiated. Published in Ethics and Human Research, they suggested a framework to monitor ongoing trials through periodic review and potential actions for responding to that review.
MRCT Center News
Mansfield Scholars: In late September, the MRCT Center met with The Mansfield-PhRMA Research Scholars Program. This scholarship program is a U.S.-Japan exchange that brings young researchers from Japan’s pharmaceutical and development field to the United States each year. Through these meetings, the researchers learn how government agencies, universities, and pharmaceutical companies collaborate to bring laboratory discoveries to the market. The program helps researchers broaden their view and understanding of U.S. healthcare policy, regulation, and pharmaceutical research and development, as well as gain first-hand insights into how the U.S. ecosystem functions to promote translational research.
Visitors from the Philippines: Visiting from the Philippines, Marimel Pagcatipunan (middle) visited the MRCT Center earlier this month. Dr. Pagcatipunan successfully completed MRCT Center’s virtual training on Data Monitoring Committees last year. She has since participated in or led multiple DMC committees for trials conducted in Southeast Asia.
MRCT Center Updates
Carolyn Riley Chapman, PhD, MS, joined the MRCT Center in October 2023. She is a Member of the Faculty of the Department of Medicine at Harvard Medical School and Lead Investigator in the Division of Global Health Equity (DGHE), Department of Medicine, Brigham and Women’s Hospital. Carolyn’s work involves collaboration with diverse stakeholders to identify and address challenges in the research and development of precision medicine, including cell and gene therapies.
Chloe de Campos joined the MRCT Center as a Student Researcher, Creative Design, during the fall of 2023. In this role, she maintains the digital asset library and Center’s image style guides. In addition, Chloe contributes to the design of both print and digital communication materials for the MRCT Center.
Chloe enrolled at Brown University in the Fall of 2019 and looks forward to completing her Computer Science degree in May 2023.
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.