Clinical Trials

Method

First time meds are administered to humans

Usually in studies of healthy, informed volunteers

Conducted under supervision of a doctor

Purpose

To determine if new compound is tolerated and if it behaves as predicted

Outcome

If the drug is seemingly non-hamful then the company can make an application with the data to the medicines and health care products regulatory agency for a certificate to go to phase 2 & 3

Method

Drug given to patients with the illness

Different dose levels given to different different patient groups

usually 200 - 400 people

Purpose

To determine if the compound is suitable for further study

Method

Medicine compared to placebo and medication already used to provide a reference standard

Neither doctor nor patient know which meds they are taking (double blind)

much larger patient group used (3000+)

Outcome

Positive results mean the company can submit the drug for marketing