August 14, 2023

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 in the world of clinical research, offering a roadmap to enhanced trial accuracy and heightened assay sensitivity through the strategic use of prognostic covariates. The FDA’s document extends its support by offering practical recommendations for implementing adjusted analyses across linear and nonlinear models.

While the guidance paves the way for innovative solutions, it sheds light on the challenge of covariate selection, a complex yet crucial aspect of analysis. The FDA highlights the potential use of scientific literature or even previous studies to form prognostic covariates.

One of the remarkable applications arising from the FDA’s guidance is the utilization of composite covariates, exemplified by the pioneering Placebell. Developed by Cognivia, Placebell stands as a placebo prognostic covariate that embodies the spirit of innovation endorsed by the FDA’s guidelines.

Join our exclusive webinar on September 6 at 11 a.m EDT to delve into this transformative FDA guidance and discover the immense potential of prognostic covariates. With a decade-long expertise in the development of prognostic covariates and facilitating adjustments for sponsors, this webinar promises to bridge the gap between theory and practice. Learn how to seamlessly translate the FDA’s vital guidance into actionable recommendations for your upcoming trials.

Attendees will gain insights into:

  • A comprehensive review of the new FDA guidance on covariate adjustment in clinical trials
  • Exploring advantages of covariate adjustment with a prognostic composite covariate — maximizing trial efficiency in compliance with the FDA guidance
  • Navigating documentation and operational requirements for implementing analysis adjustment with a prognostic baseline covariate.


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