Premarketing and Clinical Development Flashcards
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Read the first 7 Premarketing and Clinical Development flashcards as text
Which element is NOT required in an informed consent document under 21 CFR Part 50?
Answer: Identification of the sponsor's legal counsel
21 CFR 50.25 lists required elements of informed consent; identifying the sponsor's legal counsel is not among them.
Under the Common Rule (45 CFR Part 46), which category of research qualifies for exemption from full IRB review?
Answer: Survey research involving adults where responses are recorded anonymously
Anonymous survey research involving adults falls under Common Rule Category 2 exemption when disclosure cannot reasonably place subjects at risk.
A company plans to use a validated biomarker as a primary endpoint in a Phase II trial to support dose selection. What FDA pathway provides formal endorsement of this biomarker's use?
Answer: Biomarker Qualification Program
FDA's Biomarker Qualification Program formally evaluates and endorses a biomarker for a specific context of use in drug development.
According to ICH E9(R1), what does the estimand framework primarily help clinical trial designers specify?
Answer: The precise clinical question a trial is intended to answer, including how intercurrent events are handled
ICH E9(R1) introduced the estimand framework to align the trial objective, design, and analysis by explicitly defining the treatment effect of interest and handling of intercurrent events.
In a two-period crossover PK study, the primary concern with a short washout period is:
Answer: Carryover effect from the first treatment period
A carryover effect occurs when drug from period 1 is still present during period 2, confounding period 2 PK measurements.
Which FDA guidance introduced the concept of 'substantial evidence' and typically requires at least two adequate and well-controlled trials to support efficacy for a New Drug Application?
Answer: 21 CFR 314.126
21 CFR 314.126 defines 'adequate and well-controlled studies' and the evidentiary standard required to demonstrate efficacy in an NDA.
A sponsor seeks to enroll a pregnant woman in a Phase II trial of a new antiviral. Under 21 CFR Part 50 Subpart B, this population is classified as:
Answer: A vulnerable subject requiring additional safeguards
Pregnant women are a vulnerable population under 45 CFR Part 46 Subpart B, requiring additional protections and specific risk-benefit criteria.
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