May 23, 2019
The Food and Drug Administration (FDA) has recently released
a new draft guidance entitled, “Adjusting for Covariates in Randomized Clinical
Trials for Drugs and Biologics with Continuous Outcomes – Guidance for
Industry.” This document would build on the ICH guidance for industry, “E9
Statistical Principles for Clinical Trials” by specifying the appropriate uses
of analysis of covariance (ANCOVA) in randomized clinical trials. The draft
guidance is open for public comment until June 24th.
Clinical trials testing investigational drugs and biologics
in rare disease populations are more difficult than in more common diseases.
Rare disease trials must be successful despite smaller sample sizes of patients
who may have had varying disease severity, routine clinical care, and impact on
quality of life prior to enrollment in the trial. Industry sponsors struggle to
balance increasing diversity of trial participants while maximizing a trial’s
statistical power. This new draft guidance includes recommendations for using
ANCOVA to increase power without increasing statistical error.
TRiNDS offers expert data management and biostatistical support to rare disease clinical trials and research studies. Are you struggling with the analysis plans for your study? Contact us to request a quote today.