> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Covariates in Randomized Clinical Trials Guide
- URL: https://www.fdaweb.com/covariates-in-randomized-clinical-trials-guide/
- Published: 2019-04-25T12:00:00.000Z
- Updated: 2026-09-15T01:22:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143955

*Federal Register* notice: FDA has made available a draft guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.” The document says that 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. However, baseline differences in prognostic factors impair the detection and estimation of treatment effects. It says that 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 treatment effects. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-04-25/pdf/2019-08353.pdf?ref=fdaweb.com).