FDA Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Draft

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Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Draft[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。

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Draft — Not for Implementation 1 Adjusting for Covariates in Randomized Clinical Trials for Drugs 2 and Biologics 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 This guidance represents FDA’s current thinking on adjusting for covariates in the statistical 2

18 analysis of randomized clinical trials in drug development programs. This guidance provides 19 recommendations for the use of covariates in the analysis of randomized, parallel group clinical 20 trials that are applicable to both superiority trials and noninferiority trials. The main focus of the 3

21 guidance is on the use of prognostic baseline factors to improve precision for estimating 22 treatment effects rather than the use of predictive biomarkers to identify groups more likely to 23 benefit from treatment. This guidance does not address use of covariates to control for 24 confounding variables in non-randomized trials or the use of covariate adjustment for analyzing 25 longitudinal repeated measures data. 26 27 This guidance revises the draft guidance for industry Adjusting for Covariates in Randomized 28 Clinical Trials for Drugs and Biologics with Continuous Outcomes issued in April 2019. This 29 revision provides more detailed recommendations for the use of linear models for covariate 30 adjustment and also includes recommendations for covariate adjustment using nonlinear models. 31 32 The contents of this document do not have the force and effect of law and are not meant to bind 33 the public in any way, unless specifically incorporated into a contract. This document is intended 34 only to provide clarity to the public regarding existing requirements under the law. FDA 35 guidance documents, including this guidance, should be viewed only as recommendations, unless 36 specific regulatory or statutory requirements are cited. The use of the word should in Agency 37 guidances means that something is suggested or recommended, but not required. 1

This guidance has been prepared by the Office of Biostatistics in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

The term drug used in this guidance refers to both human drugs and biological products. 3

The term prognostic baseline factors used in this guidance refers to baseline covariates that are likely to be associated with the primary endpoint.

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