#1
Which phase of clinical trials typically involves testing a new drug on a small group of healthy volunteers?
Phase I
ExplanationPhase I trials test safety and dosage in a small group.
#2
Which regulatory body is responsible for approving new drugs in the United States?
FDA (Food and Drug Administration)
ExplanationFDA ensures safety and efficacy before market approval.
#3
Which of the following is an example of a preclinical study?
Animal testing
ExplanationPreclinical studies test drugs in animals.
#4
Which phase of clinical trials involves testing the efficacy and safety of a drug in a larger population?
Phase III
ExplanationPhase III involves large-scale efficacy testing.
#5
What is the primary purpose of a placebo in a clinical trial?
To serve as a standard of comparison for the experimental treatment
ExplanationPlacebos help assess the true effect of the treatment.
#6
What is the purpose of randomization in a clinical trial?
To minimize bias and ensure groups are comparable
ExplanationRandomization helps eliminate selection bias.
#7
What is the purpose of blinding in a clinical trial?
To prevent bias in assessing treatment outcomes
ExplanationBlinding ensures unbiased assessment.
#8
What is the purpose of the Data Safety Monitoring Board (DSMB) in clinical trials?
To review and ensure the safety of participants during the trial
ExplanationDSMB ensures participant safety.
#9
What is the purpose of an Institutional Review Board (IRB) in clinical research?
To ensure the protection of human subjects in research
ExplanationIRB protects participants' rights.
#10
What is the purpose of a protocol in clinical research?
To outline the objectives, design, and methodology of a study
ExplanationProtocol details study parameters.
#11
Which of the following is NOT typically included in the informed consent process for clinical trials?
Participant's insurance information
ExplanationInsurance information is unrelated to consent.
#12
What is the purpose of a crossover trial design?
To compare two or more interventions within the same group of participants
ExplanationCrossover design minimizes confounding factors.
#13
Which type of study design is particularly useful for investigating rare outcomes?
Case-control study
ExplanationCase-control studies are efficient for rare outcomes.
#14
What is the purpose of an interim analysis in a clinical trial?
To assess the accumulating trial data and potentially modify the study
ExplanationInterim analysis informs study adjustments.
#15
What is the primary objective of a dose-finding study in clinical research?
To determine the appropriate dosage range for further testing
ExplanationDose-finding studies establish safe dosages.
#16
What is the purpose of an Investigational New Drug (IND) application in the United States?
To obtain permission to test a new drug in humans
ExplanationIND application permits human testing.