September 18, 2018

While drug developers have been struggling with the placebo response for decades, Placebell© is the first commercially available technology that enables scientists to control for the placebo response in clinical studies. Tools4Patient (T4P) launched Placebell©™ in late 2017, its innovative tool for the characterization and management of the placebo response in clinical trials. Placebell©™ has been validated in the evaluation of subjects’ individual placebo response as measured by endpoints in peripheral neuropathic pain and is currently undergoing development and validation in other indications. Previous data has demonstrated that this approach substantially reduces variance due to the placebo response, and thus decreases the risk of type 2 error and increases the likelihood of demonstrating statistically significant differences between groups.   

Further to our internal R&D programs to expand Placebell©™ in new disease areas, T4P is building strategic partnerships with biotechnology, pharmaceutical and generic companies who are eager to have first-hand access to Placebell©™ and be at the cutting edge of identifying and controlling the placebo response in their indication.  A limited number of industrial collaborations are available to evaluate the utility of Placebell©™ in areas where the placebo effect is known to confound efficacy demonstration – ranging from neurological and psychiatric disorders to inflammatory and dermatological diseases, among others.  

These specific mutually beneficial collaborations aiming to minimize the risk of the placebo response in sponsor’s clinical development programs are inherently low risk for the sponsor, as inclusion of Placebell©™ does not require modification of core trial design, patient exclusion, or additional pharmacodynamic or safety measurements.  The only requirement is that the Placebell©™ Multi-Dimensional Personality Questionnaire (MPsQ) be administered to each patient once before receiving the first dose of study medication. At database lock, the T4P team will apply the Placebell©™ predictive methodology combining the questionnaire results with patient baseline characteristics to calculate the Placebell covariate. These data will be provided to the sponsor for inclusion in subsequent statistical 

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