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Sponsored by Synexus, a recruiter for clinical trials
Sponsored by Synexus,
a recruiter for clinical trials
Before any medical treatment can be licenced for use, it must undergo stringent testing in men and women. And before any treatment can be tested in humans it will have undergone extensive investigation in the laboratory and on animals.
Medical research is a highly regulated industry and before any clinical study can be undertaken, approval must be sought from the appropriate regulatory authority. In the UK, this is the Medicines and Healthcare products Regulatory Agency (MHRA).
The researchers conducting the study must draw up a protocol which will include information such as who and how many people will take part in the study, what questions the study aims to answer, what treatments will be compared and how the results will be collected.
The protocol then undergoes independent scientific review and must be approved by an ethics committee before a study can go ahead. These stringent checks are put in place to ensure that the study design is sound and that the research will respect the rights, dignity, safety and wellbeing of the participants.
Once the relevant scientific, regulatory and ethical bodies have approved the protocol, clinical studies in humans can go ahead.
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