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
Every patient's response to placebo is unique and will be influenced by their personality, expectation and environmental factors. Placebell©™ addresses the variability in clinical trial data related to each patient's individual placebo response. Reducing data variability translates to increased trial power and decreased risk of trial failure.
Powerful
Reduce variability in evaluation of treatment efficacy and increase study power.
Low Risk
Placebell©™ employs a covariate approach, which, by definition, reduces the risk of a type 2 error without increasing the risk of a type 1 error. As such, using Placebell©™ in a clinical trial does not compromise data analysis and only decreases the risk of trial failure.
Low Risk
No mathematical or operational negative impact on the trial or data.
Easily Implemented
The Placebell©™ approach is designed to be easily implemented and scalable in industrial interventional clinical trials. The approach involves a single administration of our validated personality questionnaire (MPsQ) and subsequent data transfer - with no other changes to the conduct of the trial.
Easily Implemented
Requires only minimal changes to trial design and conduct.
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.
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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
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
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.
Tools4Patient
Reducing clinical data variability. Empowering better decision making. Accelerating the launch of therapeutics to market.