Clinical Data Interchange Standards Consortium (CDISC) and the Multi-Regional Clinical Trials Center of Brigham and Women�s Hospital (MRCT Center) Collaborate to Offer Plain Language Clinical Research Definitions as a New Standard

Increasing and harmonizing the use of plain language terms and definitions in clinical research materials across the research industry supports patients, participants, and their caregivers

AUSTIN, Texas & BOSTON–(BUSINESS WIRE)–#cleardataclearimpact–Clinical research is essential for the discovery of new treatments and medical interventions that advance public health and medicine. Yet clinical research is complex, and scientific concepts are often complicated to explain. Several organizations have developed health- and disease-specific glossaries, which are often technical or intended for scientific stakeholders. Even glossaries developed for the general public are more focused on medicine and health, not research.

As a result, the MRCT Center developed a comprehensive and publicly available plain language glossary of clinical research terms and procedures�built collaboratively with patients, caregivers, and other clinical research industry stakeholders. Today we announce a collaboration between the MRCT Center and CDISC to sustain and expand the potential of this resource to provide standardized and harmonized plain language options for the technical language that is often used in participant-facing documents and materials.

Dr. Barbara Bierer, MRCT Center Faculty Director, enthusiastically endorsed the partnership. “Expanding access to the MRCT Center’s plain language glossary will advance health literacy, giving patients and their caregivers the resources they need to make informed decisions about their participation in clinical research.”

“Clear communication is essential to the success of research and the development of new treatments and therapies that people need,” said Rhonda Facile, VP, Partnerships and Business Development, CDISC. “CDISC is pleased to collaborate with the MRCT Center on this important initiative to advance health literacy.”

The resource will be governed via the robust CDISC Standards Development Process that invites input from the public broadly, expanded and sustained through the MRCT Center patient-centered consensus process, maintained and made freely available by both organizations working together to ensure the content’s quality.

We invite the public to submit comments during the Public Review period. The CDISC/MRCT collaboration and the plain language glossary will be discussed during the Q1 Controlled Terminology webinar on April 4.

About the MRCT Center

The Multi-Regional Clinical Trials Center is a research and policy center associated with two of the world’s most respected names in healthcare, academia, and research: Brigham and Women’s Hospital and Harvard University. The mission of The MRCT Center is to engage diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions to improve the integrity, safety, and rigor of global clinical trials.

About CDISC

Clinical Data Interchange Standards Consortium is a non-profit organization that develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a robust framework for generating accessible clinical research data. Driven by the belief that the true measure of data is its impact, CDISC convenes a global community of research experts representing a range of experiences and backgrounds to harness the collective power to drive more meaningful clinical research.

Contacts

Ann P. White

+1.512.363.5826

awhite@cdisc.org

Nannie Clough

+1.617.496.9807

nclough@partners.org