FDA Core Patient-Reported Outcomes in Cancer Clinical Trials Draft Guidance for Industry

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Core Patient-Reported Outcomes in Cancer Clinical Trials Draft Guidance for Industry[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。

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Draft — Not for Implementation 1 Core Patient-Reported Outcomes in Cancer Clinical Trials 1 2 Guidance for Industry 3 4 5 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 6 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 7 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 8 applicable statutes an d regulations. To discuss an alternative approach, contact the FDA staff responsible 9 for this guidance as listed on the title page. 10 11 12 13 14 I. INTRODUCTION 15 16 This guidance provides recommendations to sponsors for collection of a core set of patient-

17 reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer 18 clinical trials and related considerations for instrument selection and trial design. A lthough this 19 guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations 20 may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, 21 observer-reported outcome, performance outcome) in cancer clinical trials. R ecommendations 22 supplement previous guidance on use of PRO measures in clinical trials by providing a dditional 23 considerations specific to the cancer clinical trial setting. Guidance specific to PRO endpoints 24 and details of analytic methods are not comprehensively covered. FDA does not endorse any 25 specific PRO measure an d examples within this document are illustrative and should not be 26 construed as endorsements. 27 28 This guidance is specific to registration trials for anti-cancer therapies intended to demonstrate 29 an effect on survival, t umor response, or delay in the progression of a malignancy. 30 Demonstration of a clinically meaningful improvement in patient-reported symptoms or 31 functional impacts alone (i.e., in the absence of evidence of anti-tumor activity) would be more 32 applicable to supportive care drugs and is outside the scope of this guidance. R efer to the 33 guidance for industry Patient-Reported Outcome Measures: Use in Medical Product 34 Development to Support Labeling Claims (PRO guidance) for situations where the PRO endpoint 2 35 will be used as the primary evidence of effectiveness. PRO measurement may not be feasible in 36 all cancer trial populations (e.g., in patients with significant cognitive impairment). 37 38 The contents of this document do not have the force and effect of law and are not meant to bind 39 the public in any way, unless specifically incorporated into a contract. This document is intended 40 only to provide clarity to the public regarding existing requirements under the law. FDA 1 This guidance has been prepared by the Oncology Center of Excellence, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research, in consultation with the Center for Devices and Radiological Health (CDRH) at the FDA. 2 December 2009. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

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