FDA Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs

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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于U.S。

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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION Over the past few decades, FDA has promoted enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved, 2

primarily through broadening eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials intended to 3

support a new drug application or a biologics license application can take to increase enrollment 4

of underrepresented populations in their clinical trials. This guidance considers both demographic characteristics of study populations (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics of populations (e.g., patients with organ dysfunction, comorbid conditions, disabilities, those at the extremes of the weight range, and populations with diseases or conditions with low prevalence). Enrolling 1

This guidance has been prepared by the Office of Medical Policy and the Office of New Drugs 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

For the purposes of this guidance, the term eligibility criteria refers to the requirements for entry into a clinical trial, i.e., the characteristics the participants must or must not have to be able to participate in the study (often referred to as inclusion and exclusion criteria). Eligibility criteria are determined for each study and generally include evidence that a participant has the disease or condition being treated, often for a defined minimum duration, defined severity, and with particular symptoms or signs, and may also include characteristics such as age, sex, medical history, current health status, presence or absence of certain genotypes, blood pressure or other physiologic parameter, and absence of certain diseases. 3

This guidance applies to drugs, including biological products. For the purposes of this guidance, drug or drug product is used to refer to human drugs and human biological products that are regulated as drugs. 4

This guidance applies broadly to all types of drug products, including drugs for the treatment of serious and life-

threatening conditions or diseases for which there is an unmet medical need. 2

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