While significant placebo responses rates are often noted in clinical trials for indications like pain and depression, this issue can plague drug development in any therapeutic area – particularly in diseases that rely on subjective or patient-reported outcomes as primary efficacy endpoints. Quality of life (QoL) endpoints, for example, are often used to measure therapeutic efficacy in oncology clinical trials – but also in diseases like schizophrenia, pain, heart failure, inflammatory bowel disease (IBD), allergy and pruritus.
Belgian startup Tools4Patient recently presented data showing its novel technology Placebell©™ predicted placebo response in a Phase 2 randomized controlled trial (RCT) for osteoarthritis (OA). Placebell is the first robust technology using predictive modeling that is proven to reduce the impact of the placebo response in clinical trials under real-world conditions. Data from the Phase 2 RCT, “Predicting the Placebo Response in OA to Improve the Precision of the Treatment Effect Estimation,” was presented as a late-breaking abstract at the OARSI Connect Virtual World Congress on Osteoarthritis on April 29, 2021. This innovation by Tools4Patient is a major advancement for increasing clinical study success and reducing drug development costs and timelines.
Scientific Poster presented on April 2021 at the Osteoarthritis Research Society International Meeting. Purpose In osteoarthritis (OA) randomized clinical trials (RCTs), the magnitude and the variability of the placebo response have a negative influence when testing the statistical superiority of active compounds compared to placebo. Furthermore, the magnitude of this effect has tended to increase