Tools4Patient presented data at the MDS Congress 2021 that predicted the placebo response in Parkinson's disease (PD) in a multi-center, multi-national clinical study. This approach–called Placebell©™–to mitigate the negative impact of the placebo response is an effective tool to increase study power of randomized clinical trials (RCTs), resulting in increased success rates and decreased clinical trial timelines and cost.
The predictive, multivariate Placebell model is based on patients' psychological traits and other factors associated with the placebo response (e.g., baseline PD intensity). For this study, 94 subjects with mild to moderate PD received placebo treatment for 3 months in a blinded administration. The placebo response was measured by: MDS-UPDRS part III (primary endpoint); MDS-UPDRS part I, II and IV; IGAC, PGAC; PDQ-39 (PD questionnaire); ESS (Epworth Sleep Scale); FSS (Fatigue Severity Scale). Tools4Patient's proprietary Multidimensional Psychological Questionnaire (MPsQ) was administered once (at baseline) and was used to assess various psychological traits related to the placebo response.
Read more about the presentation and model here.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.