Grab your favorite coffee. This is where you’ll find all the substance you require, and more.
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…
Mitigating the Placebo Response in Phase II & III Clinical Trials
Phase II and III trial failure due to unexpectedly large placebo response rates is still all too common. In this blog, we explain what this means and…
Prediction of placebo response in Osteoarthritis improves estimation of the treatment effect: Impact on drug development
Placebell©™ can be used in OA and similar diseases in which efficacy is characterized using patient-reported outcomes to reduce the interference of the placebo effect and improve…
Understanding the Placebo Effect: Increasing Clinical Trial Success
Placebos are used in randomized, placebo-controlled controlled trials, in which one group (or more) receives the active treatment and the other group receives the placebo control. This…
The placebo response – a phenomenon related to the placebo group or to the individual patient?
Historically, interpretation of clinical trials relies on “assay sensitivity”, or the sensitivity to detect clinically meaningful differences between endpoints measured in the group of patients given active…
From covariates to confounding factors: the danger of having too many covariates
Clinical trials typically evaluate efficacy of experimental therapies in heterogeneous patient populations, as patient characteristics vary significantly. These patient characteristics might be prognostic factors that ultimately induce…
Regulatory Guidelines for the Use of Baseline Covariates to Increase Clinical Trial Study Power
Clinical trials data analyses can employ baseline covariates to control for factors that may impact measurement of outcomes – particularly to describe individual patient characteristics that may…
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.
Tell us about your clinical trial below and we’ll be in touch.
"*" indicates required fields