Osteoarthritis trials have relatively a rate of failure due to many factors, including disease heterogeneity, a disconnect between pain improvement and structural improvement, a strong placebo response, and high variability/inaccuracy in patient reporting of pain.
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
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.
Parkinson’s disease (PD) is one of the most common neurodegenerative disorders, as it affects 1-2 per 1000 of the population at any time(1). Although it is primarily a disease of the elderly, individuals have developed PD in their 30s and 40s(2). Gender differences pertaining to the incidence of PD are reflected in a 3:2 ratio of males to females, with a delayed onset in females attributed to the neuroprotective effects of estrogen on the nigrostriatal dopaminergic system(3,4).
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.