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Advancements in Clinical Trials: The Launch of Cognivia Signal

In a groundbreaking development for clinical trials, Cognivia, an innovative AI firm based in Belgium, has unveiled its latest product, Cognivia Signal. Designed as the world's first real-time behavioral risk intelligence dashboard, this tool aims to assist clinical trial sponsors in making more informed decisions by effectively managing behavioral variability that often complicates clinical studies.

The Need for Behavioral Insights in Trials

As clinical trials become increasingly complex, understanding the participants' motivations and behaviors is crucial. Traditional methods often fall short in providing the necessary context needed to predict dropout rates or manage placebo responses. Recognizing this gap, Cognivia Signal integrates machine learning algorithms with proprietary questionnaires to generate predictive insights throughout the course of the trial.

Dr. Bert Hartog, former Senior Director of Clinical Innovation at Johnson & Johnson and a consultant for Cognivia, emphasized the considerable cost implications of participant dropout, which can run into millions for trial sponsors due to delays and the need for patient replacements. He acknowledged that Cognivia Signal enables sponsors to preemptively identify those at risk of leaving studies and to understand the behavioral factors contributing to placebo responses.

Key Features of Cognivia Signal

The Cognivia Signal dashboard provides a comprehensive overview of participant behavior, allowing trial sponsors to gain insights into:

• - Emerging dropout risks: Identify where and why the risk of dropout is rising.
• - At-risk demographics: Pinpoint which participants are likely to leave and the underlying reasons.
• - Behavioral predictors: Evaluate behavioral factors that can amplify or diminish placebo responses.

Real-World Validation and Impact

In initial validations, Cognivia Signal demonstrated a remarkable ability to predict 93% of participant dropouts in a Type 1 Diabetes clinical trial. This capability allows sponsors to adjust protocols proactively and ensure a higher rate of participant retention, thereby leading to more reliable trial outcomes.

Chantal Gossuin, Chief Operating Officer of Cognivia, highlighted that the introduction of Cognivia Signal marks a shift towards behavior-informed clinical research. This change proposes that understanding human factors within clinical data will become a standard part of trial development processes, rather than an afterthought.

Broader Implications for Clinical Research

The implementation of Cognivia Signal is anticipated to lead to various enhancements in clinical research, including but not limited to:

• - Improved trial management: Reducing delays and streamlining processes as real-time insights are gathered.
• - Enhanced clarity in efficacy signals: Minimizing placebo-related noise to yield clearer results.
• - Operational efficiency: Facilitating better resource allocation and real-time benchmarking across multiple sites and regions.

Cognivia Signal is also the third product launched by Cognivia aimed at improving clinical trial outcomes, complementing its previous offerings, Placebell and Compl-AI, to deliver real-time insights.

About Cognivia

Cognivia stands at the forefront of transforming clinical research methodologies through AI. Their mission is to empower sponsors to make smarter, more confident decisions in trials by minimizing behavioral variability, a principal factor behind many clinical trials' failures. With AI-powered behavioral models, Cognivia predicts various risks including placebo responses, dropout likelihood, and participant engagement patterns. These insights enhance statistical power and improve the overall reliability of the trials, leading to increased success rates in drug development.

As Cognivia continues to innovate, the launch of Cognivia Signal could revolutionize how clinical trials are conducted, making them more efficient and effective at providing the necessary insights that can lead to successful drug approvals and better patient outcomes.