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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.

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  1. In a crossover trial design, what is the primary purpose of a 'washout period'?

    Answer: To eliminate carryover effects from the previous treatment

    A washout period allows the effects of the first treatment to dissipate before participants receive the next treatment, preventing carryover bias.

  2. Which allocation concealment method is considered the gold standard in randomized controlled trials?

    Answer: Centralized randomization via IVRS/IWRS

    Centralized randomization via Interactive Voice/Web Response Systems (IVRS/IWRS) provides the most robust allocation concealment because the randomization sequence is controlled remotely.

  3. A Phase II dose-finding trial using a '3+3 design' is primarily used to determine which of the following?

    Answer: Maximum tolerated dose (MTD)

    The 3+3 design is a traditional dose-escalation method used in oncology Phase I/II trials to identify the maximum tolerated dose based on dose-limiting toxicities.

  4. What distinguishes an 'adaptive trial design' from a conventional fixed design?

    Answer: It allows pre-specified modifications based on interim data

    Adaptive designs permit pre-specified modifications to trial parameters (e.g., sample size, dose, population) based on accumulating interim data without compromising validity.

  5. In a factorial trial design, two experimental treatments A and B are tested simultaneously. What is the main statistical advantage?

    Answer: It can evaluate both treatments and their interaction in a single trial

    Factorial designs allow evaluation of the individual and combined effects of two or more interventions within a single study, improving efficiency.

  6. Which trial design is most appropriate when blinding participants and investigators is impossible due to the nature of the intervention?

    Answer: Open-label trial

    Open-label trials are used when blinding is not feasible, such as with surgical interventions or behavioral therapies, though they carry a higher risk of performance bias.

  7. A non-inferiority trial is designed to show that a new treatment is:

    Answer: Not worse than the active comparator by more than a pre-specified margin

    Non-inferiority trials aim to demonstrate that a new treatment's efficacy is not worse than a reference treatment by more than a clinically acceptable margin (delta).