Predict each patient's placebo responsiveness to increase clinical trial power and reduce the risk of inconclusive trials
Placebell©™ is a novel, innovative solution to the challenges that the placebo response creates in the drug development process. 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 has clear applicability in a wide variety of therapeutic areas.
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
Placebell©™ is designed to predict each clinical trial patient's placebo responsiveness. The approach integrates important patient personality traits (measured by the MPsQ questionnaire) with usual demographic and medical history data to calculate a single value, the Placebell©™ Covariate, for each patient. Including the Placebell©™ Covariate in the statistical analyses results in a substantial increase in clinical trial power with no increased risk of type 1 error.
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Impact
Placebell©™ utilizes a composite covariate approach to reduce the variability related to the placebo response, which is a main source of analytical error in clinical trials. Reducing variability translates into increased clinical trial power, and ultimately improves the sponsor's ability to demonstrate statistically significant differences in outcomes between treated and placebo groups.
Implementation
All patients are administered our validated Multi-Dimensional Personality Questionnaires (MPsQ) measuring personality traits and expectation, among other factors. After database lock, the Tools4Patient team utilizes the questionnaire data and other patient characteristics as inputs in our disease-specific model to calculate the Placebell©™ Covariate – which can then be used in the statistical analysis to decrease data variability and increase study power. Models are calibrated in each disease using Tools4Patient's proprietary AI-based algorithm.
Scientific Collaborations
Placebell©™ can be applied to virtually any disease that experiences a high placebo response. These include chronic pain, neurology, psychiatry, dermatology, ophthalmology, women’s health, gastrointestinal disease, inflammation, oncology and others. Tools4Patient is currently seeking co-development partnerships for the development and validation of Placebell©™ in new indications.
Tools4Patient
Reducing clinical data variability. Empowering better decision making. Accelerating the launch of therapeutics to market.