Clinical Trial Design Flashcards
7 cards from real CCDM 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 Trial Design flashcards as text
What is the role of a Data Safety Monitoring Board (DSMB) in clinical trial design?
Answer: To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination
A DSMB is an independent committee that periodically reviews unblinded interim data to protect participant safety and ensure ongoing trial integrity.
In a stratified randomization scheme, stratification variables are chosen primarily to:
Answer: Ensure balance of key prognostic factors across treatment groups
Stratification ensures that important prognostic factors (e.g., disease severity, age group) are balanced between treatment arms, reducing confounding.
Which endpoint type is defined as a direct measure of how a patient feels, functions, or survives?
Answer: Clinical endpoint
Clinical endpoints directly measure patient outcomes meaningful to patients and clinicians, such as survival, symptom relief, or functional status.
In the context of clinical trial design, what is a 'run-in period'?
Answer: A pre-randomization phase used to assess eligibility, compliance, or baseline response
A run-in period precedes randomization and is used to evaluate patient suitability, wash out prior medications, or assess baseline compliance.
A Bayesian adaptive design differs from a frequentist design primarily in that it:
Answer: Incorporates prior probabilities and updates them with accumulating trial data
Bayesian designs update prior probability distributions with incoming trial data to produce posterior probabilities, enabling more flexible interim decision-making.
Which of the following best describes an 'umbrella trial' design?
Answer: Multiple targeted therapies tested within a single disease based on biomarker subgroups
Umbrella trials test multiple targeted treatments within a single cancer type, assigning patients to therapy arms based on their specific molecular biomarker profile.
What is the primary difference between 'intention-to-treat' (ITT) and 'per-protocol' (PP) analysis populations?
Answer: ITT analyzes all randomized patients regardless of compliance; PP analyzes only patients who completed treatment per protocol
ITT preserves the benefits of randomization by including all randomized patients in their assigned groups, while PP analysis may introduce selection bias by excluding non-compliers.