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Covariate Adjustment in Randomized Clinical Trials Based on Latest FDA Guidance: Application to Composite Covariates
In May 2023, the US Food and Drug Administration (FDA) released its final guidance titled “Adjusting for Covariates in Randomized Clinical Trials (RCT) for Drugs and Biological Products”. It is difficult to overstate the importance of this guidance as baseline covariate adjustment is an integral part of any statistical analysis of RCTs. Covariate…
Using the Placebell Covariate to Manage Placebo Response in Clinical Trials
Erica Smith, Chief Business Officer at Cognivia, introducing Placebell©™a tool that can be used to manage the placebo response in clinical trials.
Video Presentation – Towards an automated rating of the MDS-UPDRS motor scores
Scientific poster presented on September 2021 at the International Parkinson and Movement Disorder Society Annual Conference.
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.
Predict placebo response using patient psychology to increase trial power
Advanced methods like AI and machine learning are uniquely poised to help scientists uncover the full spectrum of patient placebo responsiveness in a clinical trial. Learn more about this approach by attending our webinar, which explains how a solution like Placebell©™ leverages a time-tested predictive…
Predicting the placebo response in OA to improve the precision of the treatment effect estimation
The current abstract is the result of a collaboration between Unity biotechnology and Tools4 patient As you know, the placebo response is one of the major sources of variability in randomized clinical trials As a result, many trials fail due to a high placebo response. Unfortunately, this is also true in OA studies. However, within Tools4Patient, we have developed…
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