Drug Information Flashcards

Which section of a clinical trial report details how participants were enrolled and the characteristics of the study population?

Answer: Methods

The Methods section describes study design, enrollment criteria, population characteristics, and how the trial was conducted.

A study reports an NNT (Number Needed to Treat) of 10. What does this mean?

Answer: 10 patients must be treated for 1 patient to benefit

NNT of 10 means 10 patients must receive treatment for one additional patient to experience the defined benefit compared to control.

Which statistical measure describes the ratio of risk in the treatment group compared to the control group?

Answer: Relative risk (RR)

Relative risk (RR) is the ratio of the probability of an outcome in the treatment group to the probability in the control group.

What is the primary purpose of blinding in a randomized controlled trial?

Answer: To reduce performance and detection bias

Blinding prevents performance bias (changes in participant/provider behavior) and detection bias (differential outcome assessment) from affecting results.

A 95% confidence interval for a drug's effect on blood pressure is -8 to -2 mmHg. What can be concluded?

Answer: We can be 95% confident the drug lowers blood pressure

A 95% CI of -8 to -2 mmHg, entirely below zero, means we are 95% confident the drug significantly lowers blood pressure.

Which type of bias occurs when patients who drop out of a clinical trial differ systematically from those who complete it?

Answer: Attrition bias

Attrition bias occurs when the characteristics of participants who drop out differ from those who remain, potentially distorting results.

Which study design provides the strongest evidence for establishing causality between a drug exposure and outcome?

Answer: Randomized controlled trial

Randomized controlled trials (RCTs) provide the strongest evidence for causality because randomization controls for known and unknown confounders.