New AI tool offers real-time insights into clinical trial participant behavior

Cognivia has launched Cognivia Signal, an AI-powered platform designed to provide real-time insights into clinical trial participant behavior. The system aims to help trial sponsors identify participants at risk of dropout and understand drivers of placebo response, supporting more efficient trial management.

The platform combines proprietary questionnaires with machine learning algorithms to deliver predictive insights as trials unfold. Early validation in a Type 1 Diabetes trial indicated that the system correctly identified 93 percent of participants who later dropped out, highlighting its potential to anticipate and mitigate attrition.

Bert Hartog, PhD, former senior director of clinical innovation at J&J and now a senior clinical innovation consultant, said: “The reasons for patient dropout and placebo response are rooted in complex behavior. The consequences can cost trial sponsors millions each year due to delayed study timelines and patient replacement costs. Cognivia Signal provides access to data that helps sponsors proactively manage some of the biggest hurdles faced in clinical development, allowing them to intervene in a timely and targeted way, reducing drop-out rates, improving study performance, and increasing the likelihood of trial success.”

Cognivia Signal is part of Cognivia’s suite of AI tools, including Placebell and Compl-AI, which aim to reduce behavioral variability in clinical trials. By highlighting risk factors for dropout or non-adherence, the tools are intended to improve the reliability of trial outcomes, reduce placebo-related noise, and enable sponsors to allocate resources more effectively across sites and regions.

Chantal Gossuin, chief operating officer of Cognivia, added: “Cognivia Signal represents a step toward behavior-informed clinical research, where understanding the human factors behind trial data becomes a standard part of the development process.”

The platform addresses a key challenge in drug development: behavioral variability in participants can compromise statistical power and obscure treatment effects. By providing sponsors with actionable insights during the trial, Cognivia Signal seeks to enhance operational efficiency and trial success rates while reducing delays.

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