Center for Information and Study on Clinical Research Participation (CISCRP) has officially published a landmark article named “Considerations for the Use of Artificial Intelligence in the Creation of Lay Summaries of Clinical Trial Results”
According to certain reports, the stated document is markedly structured to address both the opportunities and risks associated with using artificial intelligence (AI) during development of plain language communications for clinical trial results.
To understand the significance of such a development, we must take into account how Lay summaries (LS) have proven themselves as essential tools when it comes to translating complex clinical trial results into a language archetype which is clear, accurate, and accessible for patients, caregivers, and the broader community.
Now, thanks to the evolution of AI technologies, the potential for streamlining LS creation, improving efficiency, and expanding access to trial results is greater than ever before, but having said so, without thoughtful integration and oversight , AI-generated content can significantly bolster risk inaccuracies, cultural insensitivity, as well as loss of public trust.
Against that, CISCRP brings forth a specialized framework for biopharma sponsors, CROs, and medical writing vendors, a framework which offers clear, best practices for integrating AI responsibly, while simultaneously maintaining compliance with wider lay summary regulations, and at the same time, improving efficiency at scale.
Talk about the whole value proposition on a slightly deeper level, we begin from the article’s bid to reveal that human oversight remains a critical component in the bigger scheme of things. Similarly, prompt engineering also continues to hold significant importance moving forward.
You see, going by the available details, specific prompts, including instructions on tone, reading level, terminology, structure, and disclaimers are tipped to play a decisive role between usable and unusable drafts.
CISCRP’s report also called for full transparency in the context of AI’s involvement. This involves disclosing when and how AI was used, something which can really go the distance to build public trust and achieve compliance with emerging regulations, such as the EU Artificial Intelligence Act.
Hold on, we still have a couple of bits left to unpack, considering we haven’t yet touched upon the part focused on robust governance frameworks. The stated part basically preaches policies that can effectively address bias, privacy, and compliance associated with ongoing monitoring of AI systems.
Rounding up highlights would be the prospect of patient and public involvement, spanning patient perspectives in review processes to improve relevance and comprehension.
Founded in 2004, CISCRP’s rise up the ranks stems from educating the public, supporting sponsors in clinical trial transparency, and engaging patients. This the organization does through services like plain language summary development, patient advisory boards, and global educational programs.
The scale of CISCRP’s operations can also be understood once you consider it works, at the moment, across more than 45 countries to strengthen trust and improve health literacy.
“This considerations document is the result of thoughtful collaboration among industry, academia , and CISCRP.” said Kimbra Edwards, Senior Director of Health Communication Services at CISCRP. “By combining human expertise with AI innovation, we can ensure that clinical trial information remains transparent, accurate, and truly patient-centered.”
