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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…
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…
The placebo response in drug development. Part 4: Irritable Bowel Disease
As in many other diseases (e.g. pain, osteoarthritis, rheumatoid arthritis, Parkinson’s Disease, etc ), patients participating in clinical trials for IBD treatments may experience a pronounced placebo…
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…
How to Increase Clinical Study Power with Covariate Adjustment
Adjustment for covariates helps clinical trial statisticians demonstrate differences in drug effect between groups of people. In this blog, we discuss what this means and how it…
Minimizing Evaluation Error in Osteoarthritis Pain
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,…
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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