Clinical Trial Design

Question 1

Why are clinical impressions of the f=efficacy of the drug are often misleading due to:

Answer 1

Bias

Selectivity of doctors memories

Placebo effect

Question 2

The reliability of conclusions depend on:

Answer 2

Trial design

Trial procedure

Trial conduct

Trial analysis

Question 3

What is a blind trial?

Answer 3

A trial where the volunteer does not know which group they are in but the researchers do

Question 4

What is a double-blind trial?

Answer 4

Where neither the volunteers or researchers know which group they are in until the end of the trial.
Removes chance of bias and makes results more reliable.

Question 5

Trials can be:

Answer 5

Double blind
Single blind
Prospective
Retrospective

Question 6

Clinical development phases

Answer 6

Phase 1 - Volunteer studies (around 100 patients)

Phase 2 - clinical investigation to confirm kinetics and dynamics in patients (up to 500 patients)

Phase 3 - formal therapeutic trials where efficacy established and evidence of safety obtained (1000-3000 patients)

Phase 4 - post-marketing surveillance to produce evidence of long term safety