Tools4Patient Develops Predictive Model of the Placebo Response in Parkinson's Disease
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.
Roche’s Susvimo Lands FDA Approval for Diabetic Retinopathy Based on Phase III Pavilion Trial Data
May 22nd 2025One-year results from the Pavilion study showed patients who received Susvimo (ranibizumab) refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
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