Tools4Patient recently presented data showing its Placebell predicted placebo response in a Phase II randomized controlled trial (RCT) for osteoarthritis (OA). Placebell is technology using predictive modeling that is proven to reduce the impact of the placebo response in clinical trials under real-world conditions. Data from the Phase II RCT, “Predicting the Placebo Response in OA to Improve the Precision of the Treatment Effect Estimation,” was presented as a late-breaking abstract at the OARSI Connect Virtual World Congress on Osteoarthritis.
The placebo response is a major contributing factor to late-stage clinical trial failures in many therapeutic areas, and Placebell’s predictive method addresses this complex challenge. Placebell combines machine learning-based algorithms with individual patient psychology and personality data to predict the individual placebo response in a patient before the first dose of a drug is administered.
In the study, Tools4Patient applied a Placebell chronic pain model that had been built by meta-analysis that included individual data from 211 placebo-treated patients from several studies conducted by Tools4Patient. The model was pre-specified and used to predict placebo response in all trial patients receiving an intra-articular injection of a novel compound in the sponsored Phase II RCT. Results were compared for five different endpoints in the trial: average pain score, three components of the WOMAC battery focusing on pain, joint stiffness and physical function, and the patient global assessment score.
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