Description
This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this guidance, older adults are those aged 65 years and older. Specifically, this guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population. The guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials.
Scope & Applicability
Product Classes
4Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Mass balance studies should be conducted for all new molecular entities
development program for drug and biological products
Drugs for the treatment of cancer
Stakeholders
4Expert recommended for input on trial design
Entity responsible for submitting applications under section 524B
Standards for boards protecting human subjects.
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
1Guidance provides considerations for eligibility criteria in trial design.
Related CFR Sections (3)
- 21CFR201.80§ 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1) .
Each section heading listed in § 201.56(d) , if not omitted under § 201.56(d)(3) , shall contain the following information in the following order:Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
See Also (7)
- Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements (Status: Final)
- Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry (Status: Draft)
- Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Draft)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (Status: Draft)