Listing trial details on ClinicalTrials.gov may meet regulatory requirements, but entries must be written in plain language understandable to the layperson to serve the registry’s purpose of making trials more accessible to the public, experts say.

The Center for Information and Study on Clinical Research Participation (CISCRP) recently undertook a study of CT.gov listings to assess their readability for the average person. Their initial analysis, which used a small sample size of 30 trial listings, found a number of notable gaps, including a lack of summarized outcomes, a lack of causality assessments of adverse events, an overall lack of plain language (including no translations or definitions of technical terms) and an overall lack of patient-centric formatting.

The authors of the study published in Applied Clinical Trials note that sponsors in the U.S. aren’t currently required to provide plain language summaries of trial results as they are in the EU, leaving the U.S. public “with very limited, if any, plain language resources to turn to for information.”

“Usability and readability of the listings are as important as compliance if the public is to receive value from such disclosures,” wrote the authors — CISCRP founder and chairman Ken Getz, Kimbra Edwards, associate director of medical writing, and Elisabeth Moore, medical writer, health communication services.

Patient-centric listings, in addition to being written at an 11- to 13-year-old reading level, should contain the following information, CISCRP says:

• The trial’s title, first presented in plain language;
• Trial identification number;
• Who participated in the trial
  (locations and dates, inclusion/exclusion criteria and participant numbers, demographics and
  baseline characteristics);
• Why the research is needed (the condition, treatments and how this relates to the endpoint questions in the trial);
• What happened in the trial (the treatment groups, indication of whether there was a placebo, dosages and treatment frequency, definition of placebo and the study design);
• What the results were (primary endpoints and secondary endpoints and whether they were met, definition of the difference between primary and secondary endpoints, adverse reactions and serious adverse reactions, adverse events and serious adverse events); and
• Where can the patient learn more (a point of contact to obtain more information on the findings, additional patient-friendly websites, any related publications and plain-language summaries, if they exist, and any technical information, such as protocols or statistical plans).

A follow-up study will see CISCRP apply its framework to a larger sample, the authors said.

Read the CISCRP report here: https://bit.ly/3ps141U.