TrialAssure AI creates plain language summaries for 50,000 drug studies

DETROIT–Generative artificial intelligence is everywhere, including now the pharmaceutical clinical trial industry.

Detroit-based TrialAssure, a company advancing trial results disclosure and data sharing in the pharmaceutical industry, has created and published clinical trial results in plain language summary format, posting directly to TrialResults.com.

The documents were created using clinical data provided by the clinical trial sponsors to the federal registry, using generative AI built into TrialAssure’s Link product.

This includes plain language summaries for every clinical trial that has had results posted on the National Institutes of Health’s (NIH) ClinicalTrials.gov website since 2020 – nearly 50,000 documents.

Plain language summaries, a regulatory requirement elsewhere in the world, are meant to provide the public with the results of a clinical trial in a way that is more easily understood, at a sixth to eighth grade reading level. While still voluntary in the United States, there has been increased public outcry for transparency in the pharmaceutical industry, and these plain language summary documents are required in the European Union under the EU Clinical Trial Regulation No. 536/2014.

This comes at a time when just 12 percent of Americans are considered proficient in their health literacy, according to the National Assessment of Adult Literacy, and most recent research out of the NIH shows that only about 14 percent of plain language summaries are available to clinical trial participants.

Plain language summaries help patients, their families, and the public at large by:

  • providing a better understanding of the clinical study that occurred,
  • giving more context and details around what the individual studies accomplished, or didn’t accomplish, and
  • helping them understand the value of personal contributions to science and empowering clinical trial participants to continue to be involved in clinical trials in the future.

On the TrialResults.com website, the public can learn about specific clinical trials for diseases or conditions of interest. Reading one of the approximately 50,000 plain language summaries available provides a starting point to understand the clinical trial at a high level – just enter a disease, condition, or study number in the search bar. The study sponsor will always be listed in the summary, making it easy for individuals to find direct and additional information on the sponsor website.

The plain language summary documents will be released on TrialResults.com in the following five groupings by condition and/or disease:

  • Oncology (available now)
  • Metabolic
  • Mental Health and Neurological
  • Respiratory
  • All others

To be notified when additional summaries are posted, email connect@trialassure.com to be added to the mailing list.

Reviewing the ClinicalTrials.gov record for further supporting data and understanding is recommended and a link will be available on TrialResults.com for each record. It should be emphasized that a physician should be consulted before making any healthcare decisions.

Search the database at www.trialresults.com.

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