Nearly 50,000 clinical trial results submitted to the American trial registry since 2020 have been made available in simple language that is comprehensible to non-experts.
The clinical trial results disclosure and data sharing company TrialAssure produced the summaries using generative artificial intelligence and made them available online at TrialResults.com.
According to the press release:
“While still voluntary in the United States, these plain language summary documents are required in the European Union under the EU Clinical Trial Regulation.”
“Most recent research out of the NIH shows that only about 14 percent of plain language summaries are available to clinical trial participants.”
“When manually drafting a plain language summary in the pharmaceutical industry, it takes approximately 20 hours per document to write from scratch. TrialAssure was able to reduce this workload to less than one day. Time, effort and cost no longer remain an excuse for transparency.”
The company cautions that while the use of AI to produce the initial summary can save time, “the use of AI is not a complete replacement of a skilled human writer”. Also, the AI may struggle to summarise results that are not in the structured data format available on ClinicalTrials.gov. The company welcomes feedback from researchers.
TrialAssure plans to add more trial summaries in the future, and to automatically generate a plain language summary whenever a new record is made available on ClinicalTrials.gov, on a daily basis.
Patients can enter a disease, condition, or study number in the search bar.
TranspariMED does not receive funding from TrialAssure or from any other industry source. We are publishing the blog as we consider this new information portal to be of interest to patients and to the wider medical research community.