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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…
Expectations of Improvement in Clinical Trials: site or patient related?
There are multiple techniques to account for these expectations in studies, including site stafftraining, subject training before the start of the study, and applying an adjustment covariate.
The FDA highlights the tools to enhance the precision of primary analyses in clinical trials.
The FDA released its final guidance regarding the use of covariates to improve the precision of statistical analyses in clinical trials on 26 May 2023. It is…
The Placebo response in drug development Part 6: Allergy & immunology
The placebo response is widely known to compromise evaluation of pain endpoints and has been suggested to contribute to as much as ~2/3 of the measured treatment…
Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials
Cognivia team members contribute critical elements to a recent paper published in Innovations in Clinical Neuroscience. Cognivia co-authored a…
Accounting for the high reduction of power due to floor effect in design of randomised controlled trials
Purpose Outcomes in Randomized Controlled Trials (RCT) are often computed as changes from baseline of finite scales (e.g.,…
The Placebo response in drug development Part 5: Pain
Placebo-controlled clinical trials are the gold standard in drug development, in part to ensure that the efficacy of a new therapy exceeds the placebo response in the…
The next frontier in clinical research & patient management
We’re proud to be leading the charge into the next era of drug development.
Cognivia helps clinical trials reduce data variability, empower decision-making, and accelerate the launch of new therapies.
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