How are clinical trials planned?
Ideas for clinical trials come from researchers, usually doctors, nurses and other specialists. They will produce a full, detailed plan for the trial, which is called a protocol.
Clinical trial protocol
A protocol gives the reasons for doing the research and is carefully designed to safeguard the health of the participants. It should include the following:
- the background to the trial and why it should be done
- how the study will be carried out, including numbers of patients needed and which patients can be included
- the procedure or treatments to be given
- what tests the patients will have and when
- how, when and what information will be collected
- how the results will be assessed.
Rules for clinical trials
When planning a clinical trial, researchers must follow certain rules:
- the protocol is put forward for independent scientific review by people who are suitably qualified to assess it
- the research must be ethical
- as far as possible, any foreseeable risks must be no greater than the risks of the present treatment or illness.
Research Ethics Committees
Each clinical trial is carefully regulated by a Research Ethics Committee (REC). The REC is there to provide an effective safeguard for patients and to judge the wisdom and relevance of each project. No clinical trial can be undertaken without the approval of its REC.
An REC is made up of doctors, scientists, nurses and non-medical people, such as lawyers and members of the public.
If a trial is thought to be inappropriate or unethical, approval won’t be given and the research will not be allowed to go ahead. The REC can also ask for changes to the trial. If the research team wants to make changes to an already-approved trial, they must get the permission of the REC.
The research team will report unexpected side effects of the treatment or medication to the REC.
At the end of the trial the REC will require a summary of results. The REC may also ask to review any articles based on the results of the trial before they are published.