edical and research information and terminology can be challenging to understand, even at the best of times. But for patients and their loved ones, facing a difficult health situation and considering possible research options makes sifting through technical study information an even more daunting task. As an industry, we must work toward using harmonized plain language definitions to explain clinical research. The MRCT Center together with CDISC is bringing us one step closer to that goal, with the MRCT Center’s patient-centered Clinical Research Glossary becoming a global standard.

As a result, after completing a pilot, in 2021 the Multi-Regional Clinical Trials Center (MRCT Center) released a plain language glossary of 53 commonly used clinical research terms which is currently being expanded. A hallmark of this effort involves the co-development of content in collaboration with patients, caregivers, and clinical research industry stakeholders via a thorough and iterative consensus process. Plain language definitions, plus supporting details, are developed and iterated via robust written and verbal feedback collection, first with a Development Team of various stakeholders, and then with an all-patient/advocate Review Team. Definitions advance through the process and are finalized via a majority vote as to the acceptability of the definition.

Further, as appreciation for simple and understandable research language has grown—partly highlighted by communication challenges experienced during the COVID-19 pandemic—so too has an appreciation for this type of plain language clinical research glossary resource. Communicating in a common, standard language that is understandable to the public is our goal. Some examples of the plain language glossary definitions in use can be found in Table 1.

Creating standards for plain language clinical research terms

The MRCT Center and Clinical Data Interchange Standards Consortium (CDISC) have established a collaboration to sustain and expand the potential of this resource by offering the MRCT Center Clinical Research Glossary as a new CDISC standard, essentially ensuring that the terms and definitions research professionals use in communications to patients, participants, caregivers, and allies are simple and understandable. Practically, this means that standardized and harmonized plain language options will be available for many of the technical terms that are frequently used in participant-facing documents and materials. In addition, 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, and
• maintained and made freely available to the public by both organizations working together to ensure the content’s quality.

The benefits of using plain language clinical research definitions as a standard are multifold:

• Increasing Understanding
  Using plain language information can increase understanding among patients, participants, and caregivers, as well as among the community of research professionals who have the responsibility of communicating with research participants.
• Increasing Participant Engagement
  Individuals with lower health literacy are less likely to participate in research studies and less trusting of health information from doctors and other healthcare professionals. Clinical research information that is “usable and understandable” has been shown to engage participants. Organizations that attend to health literacy communicate more effectively, extending their reach to people with lower levels of personal health literacy and to different communities, including those historically marginalized and underrepresented. Organizations may benefit from increasing comprehension, trust, recruitment, and, with understandable materials, high-quality patient-reported outcome measures (PROMs).
• Increasing Data Quality and Efficiencies
  Individuals who discontinue participation in research are more likely to have found the consent form difficult to understand, as compared to those who stayed in the study. Decreasing withdrawals and loss-to-follow-up will decrease the incompleteness of data, decrease the time to study completion, and support overall data quality. Further, self-reported health literacy and medical adherence are consistently correlated, also leading to better quality of data. Using standardized plain language consistently across the clinical research life cycle saves time and resources for creators of participant-facing materials by offering specific language to use.

The definitions in the MRCT Center’s Clinical Research Glossary were co-developed with and for patients and industry professionals. Increasing and harmonizing the use of plain language terms and definitions in clinical research materials across the research enterprise supports patients, participants, and their caregivers and allies.

Learn more and access the co-created Clinical Research Glossary

The MRCT Center-CDISC collaboration offers a trustworthy, governed, sustained, and maintained lexicon of plain language clinical research definitions. The pilot Clinical Research Glossary can be found at www.mrctcenter.org/clinical-research-glossary. The expanded collection of terms and definitions will be available both on the MRCT Center and CDISC websites by early 2024. You can learn more about this collaboration and the process of bringing plain language clinical research definitions to the larger research community here.