Clinical Trials Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Clinical Trials flashcards as text
What is an 'open-label' clinical trial?
Answer: A trial where both participants and investigators know which treatment is being administered
In an open-label trial, both the participant and the investigator are aware of which treatment is being given, in contrast to blinded designs.
What is the primary goal of an adaptive clinical trial design?
Answer: To allow pre-specified modifications to trial elements based on accumulating data
Adaptive designs allow pre-specified modifications (e.g., sample size re-estimation, dose selection) based on interim data while preserving statistical integrity.
Which document formally defines the objectives, design, methodology, and statistical considerations of a clinical trial?
Answer: Clinical study protocol
The clinical study protocol is the master document that defines all aspects of trial conduct including objectives, design, eligibility criteria, endpoints, and statistical methods.
What is 'statistical power' in the context of clinical trial design?
Answer: The probability of detecting a true treatment effect when one exists
Statistical power is the probability of correctly rejecting the null hypothesis (detecting a true effect), commonly set at 80% or 90% in trial design.
What is the Expanded Access (compassionate use) program?
Answer: A pathway allowing seriously ill patients to access investigational drugs outside of clinical trials
Expanded Access allows patients with serious or immediately life-threatening conditions to access investigational drugs outside of clinical trials when no comparable alternatives exist.
In a clinical trial, what is a 'protocol deviation'?
Answer: Any unplanned divergence from the approved study protocol
A protocol deviation is any unplanned departure from the approved study protocol that may or may not affect participant safety or data integrity.
Which principle from the Belmont Report establishes that researchers must maximize benefits and minimize harms to trial participants?
Answer: Beneficence
Beneficence, one of the three Belmont principles, requires researchers to maximize possible benefits and minimize potential harms to research participants.