Description
This guidance provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence obtained from one or more multiregional clinical trials (MRCTs) intended to support a marketing application. This guidance expands on principles described in FDA’s existing guidance documents related to this topic by providing additional recommendations for the planning, design, conduct, and analysis of an oncology MRCT that may facilitate FDA’s assessment of applicability of the data to the U.S. population with the cancer being investigated and to U.S. medical practice.
Scope & Applicability
Product Classes
4Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
development program for drug and biological products
Drugs intended to treat cancer in multiregional trials
Sponsors who plan to conduct any aspect of the CDP for an oncology drug outside the U.S.
Stakeholders
2Entity responsible for submitting applications under section 524B
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Regulatory Context
Attributes
5the control arm of the MRCT should be sufficiently large to permit a robust evaluation... compared to the U.S. standard of care
Assessment of consistency between U.S. participants and overall population
Need for guidance to address demographic representativeness in MRCTs
Factors impacting study outcomes and applicability to U.S. patients
Information about biological descent relevant to U.S. population diversity
Related CFR Sections (4)
- 21CFR314.106§ 314.106 Foreign data.
(a) General. The acceptance of foreign data in an application generally is governed by § 312.120 of this chapter .Read full regulation →
- 21CFR312.120§ 312.120 Foreign clinical studies not conducted under an IND.
(a) Acceptance of studies.Read full regulation →
- 21CFR312.58§ 312.58 Inspection of sponsor's records and reports.
(a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at reasonable times, permit such officer or employee to have access to and copy and verify any records and reports relating to a clinical investigation conducted undRead full regulation →
- 21CFR312.68§ 312.68 Inspection of investigator's records and reports.
An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to § 312.62 . The investigator is not required to divulge sRead full regulation →
Related Warning Letters (1)
- 2024-12-03
Sponsor
Applied Therapeutics, Inc.
See Also (8)
- Upper Facial Lines: Developing Botulinum Toxin Drug Products (Status: Draft)
- Clinical Development and Labeling of Anti-Infective Drug Products (Status: Final)
- Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (Status: Final)
- Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry (Status: Final)
- Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry (Status: Draft)
- Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment (Status: Final)