How trials are regulated
People running clinical trials have legal obligations that are set out in Medicines for Human Use (Clinical Trials) Regulations 2004.
Conditions include:
- Anyone taking part in a trial must have a full understanding of the objectives of the research, and any risks and potential inconveniences they may experience when taking part. This information will be given to them at a meeting with a member of the research team.
- A point of contact must be provided so patients can obtain more information about the trial.
Before a clinical trial of a new medicine can begin, all of the following needs to be in place:
- The science the research is based on must be reviewed by experts.
- The researchers must secure funding.
- An organisation, such as a hospital or research institute, must agree to provide a home base for the trial.
- The Medicines and Healthcare Products Regulatory Agency (MHRA) needs to review and approve trials of a medicine and issue a clinical trial authorisation (CTA).
- A recognised ethics committee must review the trial and allow it to proceed.
The MHRA inspects sites where trials take place to make sure they're conducted in line with good clinical practice (an international quality standard).
Industry trials
All trials are regulated, whether or not they take place within the NHS. The Association of the British Pharmaceutical Industry (ABPI) has issued revised guidelines on phase one trials.
Read more about the phases of trials.
Trials of other treatments
The Department of Health's Research governance framework for health and social care describes how researchers and others are expected to work within a framework of ethical and scientific standards. This applies to all health and social research. It includes:
- promoting good practice
- reducing adverse incidents and ensuring lessons are learned
- preventing poor performance and misconduct