Representation in Research

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.

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

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

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.

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

Project leadership & STAFF

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

For Clinical Research Glossary, please link here.

Project Resources

Joint Task Force for Clinical Trial Competency

Joint Task Force for Clinical Trial Competency Project-Specific Website

Explore our project-specific website, that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.

Joint Task Force for Clinical Trial Competency

The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators and clinical research professionals that has developed a framework that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.

The MRCT Center initially co-led an effort in 2013 to convene a group of diverse stakeholders to align and harmonize core competencies for clinical research professionals into a single, high-level set of standards that could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise. Since the Harmonized Core Competency Framework was released in 2014, clinical trial researchers and training organizations have been able to rely on a single set of harmonized competencies for training and qualification purposes. Institutions around the world have utilized and applied the Framework to develop job descriptions, training modules, and other resources. The MRCT Center continues to lead the Joint Task Force for Clinical Trials Competency to adapt and evolve the Framework to meet the needs of its stakeholders globally.

Click Here to Access our Interactive Project-Specific Website >


Objectives

  • Continuously assess and evolve the JTF Core Competency Framework for Clinical Research Professionals to meet the needs of clinical researchers globally
  • Develop additional resources to aid in the professional development of clinical researchers
  • Convene virtual biannual meetings of the JTF

key milestones

project leadership & Staff

  • Barbara E. Bierer, MD, Faculty Director, MRCT Center, Co-Chair, Joint Task Force for Clinical Trial Competency
  • Stephen Sonstein, PhD. Co-Chair, Joint Task Force for Clinical Trial Competency
  • Carmen Aldinger, PhD, MPH, PMP, Project Manager

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.

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

Project Resources