Clinical Trials & Research Archives

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

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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 Research

Ideally, the participant populations enrolled in clinical trials reflect the populations of those affected by the disease or condition for which the investigational product is being tested. However, despite regulatory directives and public expectations, there remain populations that are underrepresented in clinical trials, such as women, different ethnic and racial groups, sexual and gender minorities, people living with disabilities, the elderly, and people living in rural areas. The failure to achieve appropriate representation limits both generalizable and sub-group-specific information about drug response and measures of safety and efficacy.

The MRCT Center’s Representation in Clinical Research program began in 2018 to address this challenge, publishing the Achieving Diversity, Inclusion, Equity in Clinical Research Guidance Document and Toolkit in 2020, the IRB and HRPP [DEI] Toolkit in 2022, and the Accessibility by Design in Clinical Research Toolkit in 2023. While significant progress has been made in the last few years, through the dedicated commitment and foundational work of many stakeholders across the clinical research enterprise, we remained attuned to that which we still need to learn, and actions we need to take so the future of health equity and justice look different compared to today.

Underrepresented Populations in General Disabled populations/People with disabilities Global populations/People living outside the US Financially challenged and underinsured populations LGBTQIA+ populations Limited English Proficiency (LEP) populations Resources for IRB/HRPP members

Objectives

Advance the goal of diverse representation of participants in clinical research by developing conceptual and methodological frameworks to advance the understanding of, and accountability for, diverse representation in clinical trials;
Review current methods and guidance used to define, collect, analyze, utilize, and communicate clinical trial data on race, ethnicity, sex, gender identity, sexual orientation, age, disability, and other factors;
Describe the barriers to diverse representation in research in the U.S. and in multi-regional trials, including scientific, ethical, and sociopolitical challenges; and generate and share lessons learned about potential approaches for effective communication, recruitment, and retention of underrepresented participants;
Support engagements and sustainable partnerships with community advocates, organizations, and referring providers, and diverse workforce development of clinical research personnel;
Develop and disseminate actionable and scalable solutions (“tools”) to support the inclusion of diverse populations in research.

Key Milestones

November 2024: LGBTQIA+ Inclusion by Design Toolkit
October 2024: Accessibility 101 Training Series
June 2024: Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design webinar
August 2023: Published a Delphi consensus statement: Review of Diversity, Equity, and Inclusion by Ethics Committees in Med (Cell Press)
May 2023: Released the Accessibility by Design (AbD) Toolkit at a webinar.
March 2023: Published Data Visualization Explorer: A Tool for Participant Representation in Patterns
October 2022: Published Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarity and Justification in Health Affairs
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).
March 2022: Published “Advancing the inclusion of underrepresented women in clinical research” commentary in Cell Reports Medicine.
January 2022: Published “Promoting Equity by Design in Clinical Trials” in the Association of American Cancer Institutes (AACI) Commentary.
October 2021: Published “Integrating Supported Decision-Making into the Clinical Research Process” in The American Journal of Bioethics.
April 2021 – July 2021: Leaning In webinar series “Driving Inclusion in Clinical Research” emphasizes how to plan for inclusion, implement recommendations, and sustain progress.
March 2021: Published “Justice, Diversity, and Research Ethics Review” in Science magazine
January 2021: “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and supplementary Toolkit Version 1.1 (first launched in September 2020 via a webinar with FDA Office of Minority Health and Health Equity) available via Amazon.com
November 2020: Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations. A virtual conference hosted by MRCT Center in collaboration with the FDA.
September 2020: Webinar with FDA Office of Minority Health and Health Equity to launch MRCT Center’s “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Toolkit
October 2020 – February 2021: Leaning In webinar series “Practical Approaches to Improving Diversity in Clinical Trials” focuses on concrete strategies and shared experiences for improving diversity in clinical trials
August 2020: MRCT Center releases Achieving Diversity, Inclusion and Equity in Clinical Research Guidance Document and launches Diversity in Clinical Research website

Project Leadership & Staff

Willyanne DeCormier Plosky, Program Director, MRCT Center
Hayat Ahmed, 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

Clear research communications that are understandable to patient and participant communities are critical to inclusive, representative research studies.

After completing work on return of research results that included a focus on health literacy, in 2018 the MRCT Center convened a workgroup of diverse representatives from across the research ecosystem to address the issue of limited health literacy in the clinical research context. Guided by the fundamental belief that communicators are responsible for sharing information in ways that are designed to promote understanding and empowerment, one of the workgroup’s goals was to develop clinical research-focused health literacy resources that support the integration of health literacy strategies across the clinical trial life cycle. The resulting Health Literacy in Clinical Research website launched in October 2019.

Click Here to access our interactive project-specific website >

Since then, we strive to develop MRCT Center deliverables with an eye towards promoting understanding, especially when the audience includes patients, participants, and caregivers. Our plain language, patient-centric Clinical Research Glossary which was piloted in 2020 continues to grow via a collaborative consensus-building workgroup and adopted as a CDISC global standard in April 2023.

Our newly expanded Clinical Research Glossary launched in April 2024 and includes over 110 new terms and their definitions, customized images for most of the terms, and additional information and resources to provide users with valuable background information. Looking ahead, each new term and its definition, will continue to go through the robust, consensus-based creation process as well as the CDISC public review process that invites external users to share their feedback. Further, the Clinical Research Glossary has improved search functionality, supportive accessibility features, and ample opportunities to share feedback on the site itself. The content is also easier to download for external users in a variety of formats.

Other Health Literacy in Clinical Research efforts include a suite of Data Literacy Infographics to be released in summer 2024, an ongoing virtual Health Literacy Training and Checklist for IRBs, and COVID-19 Research Flyers.

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 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

The practice of returning individual research results (IRR) has been identified consistently by research participants as desired and, often, expected. Returning individual research results 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. To respond to this need, the MRCT Center convened a taskforce to further detail the challenges associated with returning IRR and create guidance to specifically address and move beyond those challenges. These 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.

The MRCT Center invites the research community to consider how to start returning individual results and data back to participants, and to share their experiences of using the updated Guidance and Toolkit.

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

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