FDA Offers Direction on Randomized Clinical Trials

FDA Headquarters

A new draft guidance from the Food and Drug Administration (FDA) beefs up some of the recommendations in the International Council for Harmonization (ICH) E9 Statistical Principle for Clinical Trials and provides recommendations for the use of analysis of covariance (ANCOVA) in randomized clinical trials.

The target population for a new drug or biologic usually includes individuals with diverse prognostic factors, and the population studied in clinical trials should reflect this diversity, FDA said. However, baseline differences in prognostic factors impair the detection and estimation of treatment effects. “Incorporating prognostic factors in the statistical analysis of clinical trial data can mitigate this impairment and can result in a more efficient use of data to demonstrate and quantify the effects of treatment,” the agency said in the guidance.

Author: Michael Causey

Related Links:

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes

International Council for Harmonisation guidance for industry entitled E9 Statistical Principles for Clinical Trials