ABSTRACT
Learning objectives Understand the aims of clinical trials and the basic statutory requirements ■ generally stipulated for the design of clinical trials. Be familiar with the terms which describe the aims and set-up of the ■ clinical trial. Know the primary aims of the four different phases of the clinical trial. ■
Clinical trials Are the culmination of all the preliminary experimental pharmacokinetic ■ and pharmacodynamic studies of a treatment, which has been deemed ready for testing in humans. Evaluate: ■
new drugs ❚ new ‘me too’ drugs, e.g. new ❚ β-blockers, antihistamines etc new surgical and medical devices, e.g. new contraceptive devices ❚ whether a new treatment is an improvement on existing treatments ❚ by comparison, two similar treatments for a given medical problem. ❚
Are legal requirements for new surgical or medical interventions in ■ people. Must be carried out under strictly controlled conditions. ■ Must obtain the prior full and informed consent of participating patients ■ or healthy volunteers. Must be supervised by regulatory authorities such as the European ■ Medicines Agency, from whom approval must be obtained before a treatment may be put on the market.
