Placebell

Predict each patient's placebo responsiveness using the power of machine learning to increase clinical trial power and success rate

Placebell©™ is a proven solution that mitigates the risk posed by the placebo response in drug development. This approach is robust, low risk and easily adapted to different diseases, study designs and trial logistics. Placebell©™has been shown to effectively reduce clinical data variability and improve assay sensitivity in sponsored randomized controlled clinical trials.

Powerful

Reduce variability in evaluation of treatment efficacy and increase study power.

Low Risk

No mathematical or operational negative impact on the trial or data.

Easily Implemented

Requires only minimal changes to trial design and conduct.

Achievements

WORLDWIDE INVESTIGATOR SITES
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QUESTIONNAIRES COMPLETED BY PATIENTS
CLINICAL TRIALS INITIATED

Approach

The unique power of Placebell©™stems from the ability to understand patients' psychological traits in a sensitive, robust and sophisticated way. Patient psychology is evaluated using the Multi-Dimensional Personality Questionnaires (MPsQ) that is analyzed using machine learning to calculate a single value, the Placebell©™Covariate, for each patient. Including the Placebell©™Covariate in statistical analyses results in a substantial increase in clinical trial power with no risk to the data analysis.

Placebell

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Impact

Employing Placebell©™ in a clinical trial effectively reduces data variability related to the placebo response thus increasing clinical trial power. This ultimately improves the sponsor's ability to demonstrate statistically significant differences in outcomes between treated and placebo groups and improve assay sensitivity of the trial. Over time, Placebell©™ could be used to reduce the number of patients needed to achieve a defined trial power.

Implementation

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All patients are administered our validated Multi-Dimensional Personality Questionnaires (MPsQ) measuring personality traits and expectation, among other factors, only once in the trial. After database lock, the Tools4Patient team quickly calculates the Placebell Covariate, which is a score defining each patient’s relative placebo responsiveness. This can then be used in the statistical analysis to decrease data variability and increase study power.

Application of Placebell©™ In Specific Diseases

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Placebell©™ can be applied to virtually any disease for which the placebo response is significant. These include indications in pain, neurology, psychiatry, dermatology, ophthalmology, women’s health, gastrointestinal disease, inflammation, oncology and others. Tools4Patient has achieved varying levels of validation in indications ranging from chronic pain to psychiatry, ophthalmology and auto-immune disease.

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Tools4Patient

Reducing clinical data variability. Empowering better decision making. Accelerating the launch of therapeutics to market.