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.
Topic: Placebell©™
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
Patients are central to clinical trials – but the impact of patient psychology on clinical trial results is still poorly understated. In this blog, we discuss why psychology matters and how to better account for it in trial data.
Placebell©™ can be used in OA and similar diseases in which efficacy is characterized using patient-reported outcomes to reduce the interference of the placebo effect and improve assessment of the drug effect. The performance and applicability of PlacebellI©™ has recently been demonstrated in a Phase 2 RCT conducted by a biotech sponsor in subjects with moderate to severe painful knee OA.
Dr. Dominique Demolle, CEO of Tools4Patient, recently presented data at the 16th Annual Scientific Meeting of the International Society for CNS Clinical Trials and Methodology in Washington, DC. The presentation, entitled ““Modeling of Peripheral Neuropathic Pain and Osteoarthritis Placebo Response: Working Towards a Unique Model of the Placebo Response in Chronic Pain?” was authored by Tools4Patient scientist Dr. Samuel
In analgesia randomized clinical trials (RCTs), the magnitude and the variability of the placebo response negatively impacts the ability to demonstrate superiority of active compounds compared to placebo. The first objective of this analysis was to investigate parameters influencing the placebo response in PNP as a way to control for this major confounding factor.