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GUIDANCE DOCUMENT

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry April 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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

Submit Comments by 06/24/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-08470


Docket Number:
2019-08470
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 10 Administration on adjusting for covariates in randomized clinical trials in drug2 development 11 programs. This guidance provides recommendations for adjusting for covariates in randomized 12 clinical trials with continuous endpoints that are appropriate for analysis with normal-theory 13 methods, such as the two-sample t-test. Nonparametric methods, categorical outcomes, and 14 survival methods, among others, are outside the scope of this document, although some of the 15 same principles might apply to those methods as well. 

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 17 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 18 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 19 the word should in Agency guidances means that something is suggested or recommended, but 20 not required.