Tools4Patient Gosselies, Belgium has launched its Placebell©™ technology, which aims to identify and control for the individual patient placebo response in clinical trials. Placebell©™ is now available to biotechnology, pharmaceutical, generic drug and device companies who seek to improve their ability to evaluate efficacy of experimental therapies by controlling for one of the most confounding and well-documented factors in randomized clinical trials, namely the placebo response.
The Placebell©™ approach takes advantage of decades of observations and scientific research pertaining to the placebo response, and by integrating each patient’s detailed personality traits, disease characteristics, and demographics. In general, data from pilot studies are used to build a model using a machine learning-based algorithm. The model can then be applied to calculate the Placebo-covariate – a single value that describes the likelihood of that patient exhibiting a placebo response, which can then be included in statistical analyses as a covariate.
Validation studies in peripheral neuropathic pain have been completed, including data from patient cohorts from diverse neuropathic pain etiologies. These data demonstrate that Placebell©™ can effectively distinguish between placebo responders and placebo non-responders, and that the Placebo-covariate can explain a substantial amount of the intra-patient variability that is due to the placebo response.
Importantly, incorporating Placebell©™ into a clinical trial is intended to be non-disruptive to the conduct of that trial. The tool requires that our validated questionnaire be administered to trial patients once before the first administration of study medication. “As drug developers with long careers in the pharmaceutical industry, we appreciate the importance of minimizing study procedures in clinical trial that are already complex – both for cost and operational reasons, as well as data integrity”, said Dominique Demolle, Ph.D., Tools4Patient’s CEO.
The launch of Placebell©™ represents a critical step forward for T4P, which aims to develop an extensive portfolio of disease-specific Placebell tools to increase the efficiency of therapeutics and devices development, and help them fill unmet medical needs quicker.