CTA CTA Biostatistics & Study Design

Question 1

Which type of clinical trial design randomly assigns participants to treatment or control groups to minimize bias?

Accepted Answer

Randomized controlled trial (RCT)

Answer

Observational study

Answer

Case-control study

Answer

Cross-sectional study

Question 2

In a double-blind clinical trial, who is unaware of the treatment assignment?

Accepted Answer

Both the participant and the investigator

Answer

Only the participant

Answer

Only the investigator

Answer

Only the sponsor

Question 3

What is a Phase I clinical trial primarily designed to evaluate?

Accepted Answer

Safety and dosing in a small group of healthy volunteers

Answer

Efficacy in a large patient population

Answer

Long-term effectiveness compared to standard treatment

Answer

Post-market surveillance of an approved drug

Question 4

What does the term 'placebo-controlled' mean in a clinical trial?

Accepted Answer

A control group receives an inactive substance identical in appearance to the treatment

Answer

All participants receive the active drug

Answer

The trial uses historical data as a control

Answer

Participants self-select their treatment group

Question 5

Which study design follows a group of participants over time to assess outcomes?

Accepted Answer

Cohort study

Answer

Cross-sectional study

Answer

Case-control study

Answer

Ecological study

Question 6

What is the primary purpose of a Phase III clinical trial?

Accepted Answer

Confirming efficacy and monitoring adverse reactions in a large population

Answer

First-in-human safety testing

Answer

Dose-finding in healthy volunteers

Answer

Post-approval safety surveillance