PHAR0002 : clinical trials & comp medicine

Define clinical trial

scientific investigation that evaluate safety of different therapies in humans

What are the 4 phases of clinical trials?

Phase I : in healthy human volunteers, for drug safety

Phase II : in people with the diseases, for safety & tolerability

Phase III : compare new & current treatment, risks & benefits

Phase IV : after approval to monitor adverse events, marketing

How are clinical trials defined (PICO) ?

Population

Intervention

Control

Outcome

What is an open label clinical trial?

when the health care provider + patient know what drug is being given

What is a placebo-controlled trial?

Some patients get active drug & some get placebo

What is a single blind trial?

only the doctor knows whether the patient is receiving the drug or the placebo

What is a double blind trial?

Where the patients AND researchers don't know if patients have the drug or placebo

What is a parallel arm trial?

standard - A vs B trial

What is a cluster randomised trial?

Randomised by a 'unit' (area, school, family)

What is a cross-over trial?

Where all patients receive drug and placebo

Describe 3 ways to compare treatments

1) Superiority : one drug works better than another

2) Equivalence : no difference between drugs

3) Non-inferiority : Effect of drug is NOT worse (side effects)

What is the placebo effect?

The effect of a treatment that arises from expectations & response to treatment (when an inert drug is given)

What is a complementary medicine?

therapies not taught in established institutions

Give some examples of complementary medicines

Aromatherapy, homeopathy, accupuncture, osteopathy

Describe the profile of a complementary medicine user

- mental health issues

- more women than men

- in active employment / university educated

Why would someone choose alternative medicines?

- given more time & attention

- feel in control / high participation

- 'holistic' approach