Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings: Guidance for Industry | Guideline Explorer

Description

This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting (i.e., when there is no potential for cure or prolonged/near normal survival). For the purpose of this guidance, non-curative is generally defined as 1) unresectable, locally advanced, or metastatic disease in solid tumors or 2) hematologic malignancies with unfavorable long-term overall survival.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

investigational oncology product

potential toxicities of the investigational oncology product

Biological products

development program for drug and biological products

Investigational cancer drugs

Drugs being evaluated in clinical trials

Stakeholders

2

Clinical investigators

Source of safety information in clinical trials

Regulatory Context

Regulatory Activities

2

early stage dose escalation studies

In early stage dose escalation studies, it may be reasonable to evaluate safety

Clinical trials

Development program for drugs intended for sGERD treatment

Attributes

1

Eligibility criteria

Guidance provides considerations for eligibility criteria in trial design.

Technical Details

Testing Methods

1

pre-specified subgroup analyses

analyses of efficacy may be performed in pre-specified subgroup analyses

Clinical Concepts

6

safety

evaluate safety in all patients

available therapy(ies)

evaluate patients who have received available therapy(ies)

homogeneous patient population

interpretation of efficacy results requires a homogeneous patient population

efficacy results

interpretation of efficacy results requires a homogeneous patient population

Available therapy

Existing treatment options for cancer

Non-curative setting

Unresectable, locally advanced, or metastatic disease or hematologic malignancies with unfavorable survival

Identified Hazards

Hazards

1

toxicities

Emerging information in dose-escalation trials.

Related CFR Sections (2)

21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
21CFR312.42§ 312.42 Clinical holds and requests for modification.
(a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjectRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to ensure that the investigation was conducted according to the investigational plan

21

Failure to submit an Investigational New Drug application (IND)

9

Unapproved new drug

5

Failure to obtain informed consent

5

Misbranded drug

4

Failed to ensure that the investigation was conducted according to the investigational plan

3

Enrollment of subjects who do not meet eligibility criteria

3

Failure to submit INDs for the conduct of clinical investigations

3

unapproved new drugs

2

Failure to retain records required to be maintained

2

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics