Clinical Trials & Research Archives

Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance

Public Comments

Comments provided on: January 7, 2020

Comments provided to: National Institutes of Health, Bethesda, Maryland

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Thai)

Framework

Developed on: December 2022

Developed by: Joint Task Force for Clinical Trial Competency / Mahidol University, SICRES (Siriraj Institute of Clinical Research), NCGM (National Center for Global Health and Medicine)

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Disclosure and Transparency for Clinical Data Summit

Presentation

Presented on: August 13, 2018

Presented at: Disclosure and Transparency for Clinical Data Summit, Philadelphia, PA

View Presentation

Return of Individual Research Results Resources: Resources for Participants

Tools

Published on: June 2022

Developed by: MRCT Center Return of Individual Results Task Force

View Tools

Related Resources

Additional Resources, maintained on our project specific
Return of Individual Research Results website:

IRB Approval Checklist for Returning IRR

Healthcare Provider Contact Form Template

IRR Information Sheet for Participants Template

Informed Consent Sample Language

Representation in Clinical Research

The participant populations enrolled in clinical trials should reflect the populations of those affected by the disease or condition for which the intervention is being tested. Representation in research is basic, good science. Everyone should be able to “see themselves” in clinical trials and research data and to know whether approved vaccines, therapies, devices, and medications (including medication doses) are right for them. Without appropriate representation of the people who will use the tested products, we don’t know how safe or effective those products are for different people (e.g., people with varying body types, genetic backgrounds, co-existing health conditions, income levels, environmental exposures, and/or life stages).

Despite efforts, there is still a great deal to learn as we work toward greater access to clinical trials and improved health outcomes. The barriers that potential participants face in finding and accessing clinical trials differ, as do the approaches that might mitigate these challenges. And, while the MRCT Center released guidance and tools to address representation in research early in the COVID pandemic, we continue to learn more about the specific ways that people from different populations can best be supported to participate in clinical research.

Underrepresented populations (in general) Disabled populations/People with disabilities Financially challenged and underinsured populations Global populations/People living outside the U.S. LGBTQIA+ populations Limited English Proficiency (LEP) populations Pregnant and Lactating Populations Resources for IRB/HRPP members

Objectives

Describe the obstacles potential participants are facing in accessing U.S. and multi-regional clinical trials, including scientific, ethical, and geographical challenges; and generate and share lessons learned about potential approaches for effective communication, recruitment, and retention of participants from a variety of backgrounds.
Support engagements and sustainable partnerships with community champions, organizations, and referring providers, and workforce development of clinical research personnel. Develop and disseminate actionable and scalable solutions (“tools”) to support representation in research, greater access to clinical trials, and improved health outcomes.

Key Milestones

February 2026: published “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs” in NEJM Evidence
May 2025: Released LGBTQIA+ Inclusion by Design Toolkit v. 2.0.
September 2024-March 2025: Launch of four additional tools in Global Representation: Embedding Ethical Considerations Relating to Global Representation, Working with Partner Countries to Strengthen Research Capacity Building Relating to Global Representation, Global Representation Roadmap, and Model Diversity Action Plan
October 2024: Accessibility 101 Training Series.
September 2024: Launch of two tools in Global Representation: Global Representation Roadmap and Model DAP.
May 2024: Toward a National Action Plan for Achieving Diversity in Clinical Trials released.
May 2023: Released the Accessibility by Design (AbD) Toolkit at a webinar.
June 2022: Held webinar to launch the Equity by Design Metrics Framework and User Guide.
June 2022: Launched IRB and HRPP Toolkit.
March-April 2022: Conducted a virtual six-part training on “Equity by Design in Clinical Research: Cancer Trials” for over 450 clinical research practitioners (live course, for CME credit; now available as an online course, not for CME credit).
April 2021 – July 2021: Leaning In webinar series “Driving Inclusion in Clinical Research” emphasizes how to plan for inclusion, implement recommendations, and sustain progress.
August 2020: MRCT Center releases Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document.

Project Leadership & Staff

Willyanne DeCormier Plosky, Program Director, MRCT Center
Hayat Ahmed, Program Manager, MRCT Center
Blythe Chen, Research Assistant II, MRCT Center
Emina Berbic, Program Manager, MRCT Center
Barbara Bierer, Faculty Director, MRCT Center

Project Resources

Health Literacy in Clinical Research

Health Literacy in Clinical Research Project-Specific Website

Principles of health literacy provide a basis from which to adopt and integrate health literacy practices into clinical research.

Project-Specific Website

Health Literacy in Clinical Research

Everyone benefits from clear communications that promote audience understanding and empowerment, including members of the clinical trial ecosystem. Clear research communications that are understandable to patient and participant communities are especially critical to inclusive, representative research studies.

As such, the MRCT Center launched an effort in 2018 to develop clinical research-focused health literacy resources with a workgroup of diverse representatives to support the integration of health literacy strategies across the clinical development life cycle. The resulting Health Literacy in Clinical Research website launched in October 2019.

Click Here to access our interactive project-specific website >

Extending from this, our plain language, patient-centric Clinical Research Glossary, which was piloted in 2020 and adopted as a CDISC global standard in 2023, continues to grow via a collaborative consensus-building workgroup and public review process. New terms and definitions are released every September. If you’d like to be notified when new terms are available, please fill out this form.

Other recent Health Literacy in Clinical Research efforts include a suite of Data Literacy Infographics, a virtual Health Literacy Training and Checklist for IRBs, and an ongoing project to update the Health Literacy in Clinical Research website content.

Objectives

Establish and support initiatives that increase the use of health literacy best practices when developing clinical research-related communications for patients, participants and their caregivers.
Develop and share resources with sponsors and funders, investigators and their study teams, and institutional review boards that maximize their efforts to integrate health literacy principles throughout the clinical trial life cycle from recruitment and informed consent through close-out and return of results.
Promote the use of plain language in clinical research via a harmonized, patient co-developed Clinical Research Glossary that can be used across the research industry, and used by research professionals and potential participants to foster clear, bi-directional information exchange.

Key Milestones

September 2025: Released Version 3.0 of the Clinical Research Glossary
April 2025: Released a suite of data literacy infographics and hosted a launch webinar with PHUSE
September 2024: Released Version 2.0 of the Clinical Research Glossary
September 2024: Published “Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age” in Medical Writing
April 2024: Launched expanded Clinical Research Glossary
October 2023: Presented “Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials” webinar
June 2023: Published “Communicating complex numeric information in clinical research” in Frontiers.
April 2023: MRCT Center and CDISC announce collaboration solidifying the Clinical Research Glossary as a CDISC global standard
June 2022: Launched online Health Literacy Training for IRBs
March 2022: Launched Clinical Research Glossary Expansion activities
August 2021: Released health literacy resources for IRBs
June 2021: Launched Clinical Research Glossary
June 2020: Launched Plain Language Clinical Research Glossary Pilot workgroup
May 2020: Released COVID-19 research fliers that were developed and designed using health literacy best practices.
March 2020: Launched a small Taskforce to develop a training resource on Health Literacy Considerations for Institutional Review Boards
October 2019: Launched interactive Health Literacy in Clinical Research website
April 2018: Health Literacy in Clinical Research Workgroup launch

Project leadership & STAFF

For Health Literacy in Clinical Research project, please link here.

For Clinical Research Glossary, please link here.

Project Resources

Return of Individual Results

Return of Individual Research Results Project-Specific Website

The guidance, recommendations, and tools on this website can further enable researchers to return individual research results (IRR) to participants.

Project-Specific Website

Return of Individual Results

Returning individual research results (IRR) is consistently described by research participants as a desired and expected practice. It can benefit individuals, communities, and the research enterprise by increasing trust and transparency in research, and by adding value to research participation.

The MRCT Center first convened a workgroup in 2015 to address the absence of standard guidelines and criteria related to returning IRR. SACHRP provided initial guidance for return of individual research results in 2016, and the MRCT Center released recommendations in guidance and toolkit documents in 2017.

Despite significant attention and effort, as well as consensus on the importance of returning individual research results, adoption of the practice continues to lag. Updated resources were released in 2022, followed by a series of case studies to highlight scenarios where individual results and data were successfully returned to participants.

To continue growth and development in this space, and partly in anticipation of a new NIH policy on the return of individual results, the MRCT Center recently launched a new industry workgroup focused explicitly on implementation. Anticipated deliverables include a dedicated playbook, practical case study, and commitment statement.

Click Here to Access Project-Specific Website >

Objectives

Identify both the opportunities and common barriers encountered throughout the process of returning individual research results
Provide guidance and resources to help organizations return individual research results in a respectful and compliant manner
Promote the value of organizations to prepare for and prioritize returning individual research results

Key Milestones

June 2026: Launch of industry workgroup to address return of individual results implementation challenges and opportunities
Summer 2023: Facilitated Digging Deeper Webinar Series with case study authors
April 2023: Release of Return of Individual Results Case Studies
March 2022: Launch of Return of Individual Results (IRR) website
January 2021: Initiated Return of Individual Results Project Update/Revision Taskforce
December 2017: Return of Individual Results to Participants Recommendations Document Version 1.2 and Return of Individual Results to Participants Toolkit Version 1.2 released and “Return of Individual Results to Participants: Principles” Nov 2017 version released; results from Task Force on Communication of Research Results survey were presented at MRCT Center Annual Meeting.
June 2017: “Return of Individual Results to Participants: Principles” Version 2.1 released
February 2017: “Return of Individual Results to Participants: Principles” released
January 2017: Genomics Sub-Group launched to expand on genetic/genomic sections of Individual Return of Results Guidance Document and Use-Case Sub-Group launched to develop simulations to test the workgroup output in real life situations
December 2016: Draft Recommendations Document, Toolkit and Principles presented at MRCT Center Annual Meeting
April 2016: Task Force on Communication of Research Results launched to (1) understand current practices in communication of research results to clinical trial participants and (2) develop recommendations to guide communication processes between clinical investigators, primary care physicians, and study participants
December 2015: Launched Return of Individual Results Working Group

Project leadership & Staff

Original project (2015-2017) was co-chaired by:

Barbara E. Bierer, MD. Faculty Director, MRCT Center
Debra Mathews, PhD, MA. Assistant Director for Science Programs, Johns Hopkins
David Pulford, PhD. Genetics Therapy Area Head, GSK
Sandra Prucka, MS. Clinical Innovations, Eli Lilly and Company
Carmen Aldinger, PhD. Project Manager, MRCT Center

Taskforce for the project update (2020-current):

Barbara E. Bierer, Faculty Director, MRCT Center
Sylvia Baedorf Kassis, Program Manager, MRCT Center
Linda Coleman, Director of Human Research Protection Program, Yale University
Anna Kang Liu, Director, Pre-Approval Access and Bioethics, Genentech
David Leventhal, Senior Director, Clinical Trial Experience, Pfizer
Megan McBride, Associate Director, Janssen Clinical Innovation
Nancy Levitan Poorvu, Patient Advocate
Sandra Prucka, Director of Genetic Counseling for Clinical Services, Asst. Professor of Clinical Medical and Molecular Genetics, Indiana University
Kate Robins, Patient Advocate
Jessica Scott, Head of R&D Patient Engagement, Takeda
Jamie Tyrone, Patient Advocate
Carol Weil, Program Director for Ethical and Regulatory Affairs, National Cancer Institute
Sarah White, Executive Director, MRCT Center
Sylvia Baedorf Kassis, Program Director, MRCT Center