A clinical trial is a research study designed to answer specific questions about a new treatment. There are very strict rules governing clinical research. Before a new treatment can be tested, the proposed study must be scrutinised by an ethics committee which has the power to advise hospital management on whether the research is appropriate. Ethics committees include clinical experts as well as lay-members.
An approved set of rules, called a protocol, is set out indicating the people that can be approached for the study and the schedule of investigations, treatment and outcome measures to be evaluated.
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