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Covariate Adjustment in Randomized Clinical Trials Based on Latest FDA Guidance: Application to composite covariates
In May 2023, the FDA has unveiled its definitive guidance titled “Adjusting for Covariates in Randomized Clinical Trials (RCT) for Drugs and Biological Products”. This guidance marks a pivotal moment…
Video Presentation – Modeling of the Placebo Response in Parkinson’s Disease
Scientific Poster presented on September 2021 at the International Parkinson and Movement Disorder Society Annuel Meeting.
Modeling of the Placebo Response in Parkinson’s Disease
The magnitude and the variability of the placebo response have a confounding influence when testing the superiority of active compounds…
Towards an automated rating of the MDS-UPDRS motor scores
Tools4Patient has developed an IMU-based device where sensors are placed on the tip of the index finger and thumb bilaterally. The device was…
Where Does Placebo Response in Clinical Trials Come From? 6 Influences
Placebo response is a major source of noise in trial data analysis, muddying the results and making it more difficult to detect true treatment effect. We know…
The Importance of Patient Psychology in Health and Clinical Research
When we think about patient characteristics that influence health, disease, and clinical research, we tend to think about things like vital statistics, medical history and genetic makeup…
Clinical Trial Statistical Analysis: How to Minimize Noise
The main objective of most clinical trials is to evaluate efficacy and safety of an experimental treatment. To do this, statisticians compare the response of the drug-treated…
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