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