FDA Cancer Clinical Trial Eligibility Criteria Brain Metastases

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Cancer Clinical Trial Eligibility Criteria: Brain Metastases 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 This guidance is one in a series of guidances that provide recommendations regarding eligibility 2

criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the 3,4

treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with brain metastases. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials. A clinical trial’s eligibility criteria (for inclusion and exclusion) are essential components of the trial, defining the characteristics of the study population. Because there is variability in investigational drugs and trial objectives, eligibility criteria should be developed taking into consideration the mechanism of action of the drug, the targeted disease or patient population, the anticipated safety of the investigational drug, the availability of adequate safety data, and the ability to recruit trial participants from the patient population to meet the objectives of the clinical trial. However, some eligibility criteria have become commonly accepted over time or used as a template across trials without clear scientific or clinical rationale. Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients’ access to clinical trials, and 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

For the purposes of this guidance, references to drugs and drug and biological products 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). 3

Topics of the other three guidances are related to eligibility criteria for patients with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infections; for patients with organ dysfunction or with prior or concurrent malignancies; and regarding minimum age considerations for inclusion of pediatric patients. 4

The recommendations in this guidance do not apply to trials designed specifically to assess the safety and efficacy of investigational drugs for the treatment of primary brain cancers (e.g., glioblastoma) or brain metastases.

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