Session 1

Question 1

Define clinical trial?

Purpose of clinical trials?

Answer 1

A planned experiment with patients to elucidate the best future patient treatment

To provide evidence for treatment efficacy (intervention improvement) and safety

Question 2

Non randomised trials?

Issue?

Issue with historical controls?

Answer 2

Some patients with different treatment and compare

Bias clinician and confounding

Less info on bias and confounding and different overall treatment

Question 3

Describe a randomised clinical trial

2 outcomes?

3 outcomes?

Answer 3

Identify and invite eligible patients, randomly/no bias pick patients to have the new treatment and monitor adherence and follow up in identical ways.

Primary (sample size calculation) secondary (side effects/outcomes of interest)

Path-physiological-tumour size
Clinical outcome-death
Patient focused-QOL

Question 4

Benefits of random allocation?

Define confounded?

Issue with known treatment allocation?

Answer 4

No bias or xonfounding

A factor associated with an exposure and independently a risk for a disease

Behavioural effect from patient, non treatment effect of clinician alters their time resources into patients.

Question 5

3 blind trials?

When are blind trials hard?

Answer 5

Named by how many of the three (patient/clinician/accessor) know about the trial

Surgery,psychotherapy

Question 6

Use of placebo?

How to reduce losses to follow up?

Answer 6

To know if change in patient is due to treatment or just receiving healthcare.

Make follow up to minimise inconvenience, maintain contact throughout, honesty about commitment

Question 7

To increase compliance?

Explanatory trial?

Pragmatists?

Answer 7

Simplify instructions and monitor via pill counts

Analysis only those that completed the follow up and compliance so only measures physiological effects.

Analyses on original allocation even if no compliance, so compares effects in clinical practise not just physiological effects.

Question 8

Clinical equipoise and ethical recruitment are important in ethical issues. Describe them?

Answer 8

Uncertainty or ignorance about the better treatment is equipoise

Unethical recruitment e.g pregnant women are high risk of harm

Question 9

Difference between clearance and elimination?

Answer 9

Clearance is volume of blood cleared per unit time

Elimination is amount eliminated per unit time (mg/min)