FDA Cancer Clinical Trial Eligibility Criteria Available Therapy in Non-Curative Settings Draft

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Cancer Clinical Trial Eligibility Criteria Available Therapy in Non-Curative Settings Draft[附网盘链接]是Food And Drug Administration于不久前发布的FDA标准，适用于United States。

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Draft — Not for Implementation 1 Cancer Clinical Trial Eligibility Criteria:

2 Available Therapy in Non-Curative Settings

1

3 Guidance for Industry

4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 I. INTRODUCTION 17 18 This guidance provides recommendations to clinical investigators and sponsors regarding the 2

19 inclusion of patients who have not received available therapy (commonly referred to as existing 3

20 treatment options) for their cancer in clinical trials of drugs and biological products for the

21 treatment of cancer in the non-curative setting. For the purpose of this guidance, non-curative is

22 generally defined as 1) unresectable, locally advanced, or metastatic disease in solid tumors or 2) 23 hematologic malignancies with unfavorable long-term overall survival. 24 25 The contents of this document do not have the force and effect of law and are not meant to bind 26 the public in any way, unless specifically incorporated into a contract. This document is intended 27 only to provide clarity to the public regarding existing requirements under the law. FDA

28 guidance documents, including this guidance, should be viewed only as recommendations, unless

29 specific regulatory or statutory requirements are cited. The use of the word should in Agency 30 guidance means that something is suggested or recommended, but not required.

31 32 33 II. BACKGROUND

34 35 For clinical trials of all products regulated under 21 CFR part 312, including drugs, FDA must

36 determine that study subjects are not exposed to an unreasonable and significant risk of illness or

37 injury (312.42(b)(1)(i) and (b)(2)(i)) to allow such trials to proceed. Therefore, eligibility criteria

1

This guidance has been prepared by the Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

Refer to the guidance for industry Expedited Programs for Serious Conditions – Drugs and Biologics (May 2014) for a description of available therapy. 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. 3

References to drugs include drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262).

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