Clinical trials are strictly regulated, to try to make them ethical and safe. Here’s our guide to the rules, how trials are approved, and the types of organisation that support them.
Regulation around clinical trials is tight. Generally speaking, the rules are there to ensure that every phase of a trial is run safely, ethically and with the full consent of everyone taking part.
Under the law, researchers must ensure that you fully understand the objectives of the research, along with any risks and inconveniences you may experience, when you take part in a clinical trial.
They must give you this information at a meeting with a member of the research team; and they must also provide a point of contact so you can find out more when you need to.
These rules form part of the Medicines for Human Use (Clinical Trials) Regulations 2004.
For more information on what else you might want to find out before a trial starts, see our section on what you need to know.
Researchers must ensure you understand the objectives of the research when you take part in a clinical trial
In addition, before a clinical trial of a new medicine can take place:
Experts must review the science on which the research is based
The researchers must secure funding for the trial
An organisation, such as a hospital or research institute, must agree to provide a home base for the trial. A recognised ethics committee must review and approve the trial and allow it to proceed (see below for more info on how trials are approved)
The Medicines and Healthcare Products Regulatory Agency (MHRA) also inspects sites where trials take place, to make sure they're conducted in line with good clinical practice.
Clinical trials have to go through a rigorous process before they are approved:
The protocol – that is, the overall plan for the trial and all its phases – should be approved by a group of researchers not involved in the trial. This is called independent scientific review or peer review.
An independent research ethics committee will review the protocol. This committee is responsible for looking after your rights, safety, dignity and wellbeing when you take part in NHS research. It can decide whether or not the trial can go ahead. The committee checks – among other things – that:
The potential benefits of a new treatment are likely to outweigh the side effects
Patient information is clear and satisfactory
People will be recruited for the trial in an appropriate way
There will be compensation available if something goes wrong
It will also look at the patient information sheet and the consent form, as well as the protocol, and may ask for changes before it gives the go-ahead.
Researchers aren’t allowed to change the protocol without telling the ethics committee. They must also tell it if there are any serious unexpected side effects.
The ethics committee can stop a trial at any time if it has any concerns about the welfare of people taking part.
When a clinical trial produces a large amount of information over several years, a data monitoring committee will be involved. Such trials will have early warning systems that help identify whether the benefits of a treatment are so good, or the risks so high, that the trial should be stopped early. The role of the committee is to review the data and make this decision.
Each hospital that wants to take part in the trial has a check called a site-specific assessment (SSA). The assessment makes sure that the hospital has the staff, equipment and expertise to carry out the trial. SSAs must be done for all trials of new treatments or procedures.
In certain cases, the research study may require approval from other groups. For example, a trial involving treatments that expose people to radiation would need a certificate from a specialist committee.
In a clinical trial that tests a medicine or medical device, the MHRA must review and approve the trial, and issue a Clinical Trial Authorisation (CTA).
Many different types of organisation support clinical trials. These include:
The Medical Research Council and government departments or agencies
All trials, no matter who funds them, are checked and monitored in similar ways to make sure that the people who take part are protected. Each trial also has a sponsor who is responsible for the conduct of the trial. The sponsor may be the organisation funding the trial or the institution hosting the research, for example, a university.
Many of these organisations involve patients to help decide what research studies will be conducted in the future. It is essential that research takes into account the needs and interests of the people it is trying to help. Specialists are often aware of gaps in knowledge about diagnosis and treatment but patients and their families may also see aspects of care that need further research.
The James Lind Alliance is a Department of Health supported method of enabling clinical research to be determined by those who have close experience of given conditions.