Health Literacy in Clinical Research
Focus Area: Current Project
Focus Area: Ethics, Conduct, and Oversight
In April 2018, the MRCT Center convened a workgroup of diverse stakeholders, including people from industry, foundations, academia, patient advocates and advocacy groups, non-profits and government representatives. Taking a systems-based approach, the workgroup developed clinical research-focused health literacy resources for all clinical research stakeholders such as the primary authors, reviewers, and communicators of study information to implement at all points throughout the clinical trial life cycles. The resulting deliverable, the MRCT Center’s Health Literacy in Clinical Research website, launched in October 2019 and can be accessed here.
Since the launch, the MRCT Center’s programmatic focus on health literacy throughout the clinical research process has continued to grow. In addition to considering how health literacy best practices can enhance other projects’ deliverables, especially when designed for an audience of patients and participants, the MRCT Center has initiated additional health literacy-related projects:
- The Plain Language Clinical Research Glossary Pilot
There is a need for a comprehensive and publicly available plain language clinical research glossary that is built collaboratively with patients, caregivers and other clinical research industry stakeholders. In addition, a common resource for explaining procedures frequently used in research, including images and video descriptions, would be helpful for potential and enrolled participants. Such a resource applies across all clinical research communications from initial introduction and recruitment through to the end of the study and the return of results.
The MRCT Center has assembled a small pilot workgroup of dedicated stakeholders from across the clinical development spectrum, and including patients and patient advocates, to pilot the development of such a glossary. The workgroup launched in June of 2020 and the pilot work is expected to be carried out through December 2020.
2. Health Literacy Considerations for Institutional Review Boards
Institutional Review Boards are in a unique position to influence the way information is presented to patients and participants. IRBs can integrate health literacy best practices into:
- the design of their own institutional templates and development of boilerplate language
- educating their staff, members and study investigator community about best practices
- the review of submitted research protocol submissions, and
- their recommendations to investigators and study staff under their purview.
A variety of resources, including training materials and an IRB-focused health literacy review checklist are currently under development by a small MRCT Center-led workstream.
3. COVID-19 Research Fliers
In May of 2020, the MRCT Center released a suite of COVID-19 research fliers that were developed and designed using health literacy best practices. Additional educational materials to explain general research principles and specific COVID-19 research concepts continue to be developed and are released as they become available.
Status: Dissemination and Communication
Impact: The launch and dissemination of the website is under evaluation. Website analytics, user surveys, and other evaluation methods are being employed to assess the impact of this initiative.
- To address barriers to the adoption of existing resources in health literacy in the context of clinical research-related communications.
- To identify the opportunities for sponsors and funders, investigators and their study teams, and institutional review boards to integrate health literacy throughout the clinical trial life cycle from recruitment and informed consent through close-out and return of results.
- February 2018: Initial meeting of leadership team
- April 2018: Workgroup launch
- December 2018: Presentation at MRCT Center Annual Meeting
- October 2019: Launched interactive Health Literacy in Clinical Research website
- December 2019: Panel Discussion at MRCT Center Annual Meeting
- March 2020: Launched a small team effort to develop a training resource on Health Literacy Considerations for Institutional Review Boards
- May 2020: Released COVID-19 research fliers that were developed and designed using health literacy best practices.
- June 2020: Launched Plain Language Clinical Research Glossary Pilot workgroup
- Evaluation of website
This project was co-chaired by:
- Barbara E. Bierer, MD. Faculty Director, MRCT Center
- Laurie Myers, MBA. Global Health Literacy Director, Merck (MSD)
- Christopher Trudeau, JD. Associate Professor, University of Arkansas for Medical Sciences, Center for Health Literacy, and Faculty of Law at the University of Arkansas Little Rock, Bowen School of Law
- Sarah White, MPH. Executive Director, MRCT Center
Hayat Ahmed, MSc., Project Manager, MRCT Center
Sylvia Baedorf Kassis, MPH. Program Manager, MRCT Center