CATO Associate Protocol Development & Study Design Flashcards

What is the purpose of a feasibility assessment conducted before finalizing a clinical trial protocol?

Answer: To evaluate whether sites can enroll eligible participants and conduct the trial as designed

Feasibility assessments determine whether investigative sites have adequate patient populations, infrastructure, and staff capabilities to successfully execute the protocol as written.

In the context of protocol development, what is a 'stratification factor'?

Answer: A variable used to balance randomization across subgroups to reduce confounding

Stratification factors are variables (e.g., disease severity, age group) used during randomization to ensure treatment arms are balanced with respect to important prognostic characteristics.

Which document describes the preclinical and clinical data on an investigational product to guide safe use in a clinical trial?

Answer: Investigator Brochure

The Investigator Brochure (IB) compiles all available clinical and non-clinical data on the investigational product to guide investigators in conducting the trial safely.

What is the 'intent-to-treat' (ITT) analysis population in a clinical trial?

Answer: All randomized participants analyzed in their assigned treatment group regardless of actual treatment received

The intent-to-treat population includes all randomized participants analyzed according to their randomly assigned treatment, preserving the benefits of randomization and reducing selection bias.

Which risk is most directly mitigated by having a pre-specified Data Monitoring Committee (DMC) for an ongoing trial?

Answer: Risk of continuing a trial that is showing unexpected harm or clear benefit

A DMC (also called DSMB) independently reviews interim safety and efficacy data to recommend stopping or modifying the trial if there is evidence of unexpected harm, clear benefit, or futility.

What does the term 'protocol deviation' refer to in clinical trial operations?

Answer: Any departure from the approved protocol procedures or requirements

A protocol deviation is any unplanned departure from the approved protocol, including variations in study procedures, dosing, or visit schedules, which may or may not affect data integrity or participant safety.

When finalizing a clinical trial protocol, which regulatory body in the United States must grant approval before an investigational drug can be used in human subjects?

Answer: Food and Drug Administration (FDA) via an IND application

In the US, sponsors must submit an Investigational New Drug (IND) application to the FDA and receive authorization (or absence of a clinical hold) before initiating clinical trials with an investigational drug.