Safety in clinical trials

Medicines and Healthcare Products Regulatory Agency Back to top

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) makes sure trials meet international standards of good practice, which are there to protect people taking part. All serious side effects must be reported.

Research Ethics Committees Back to top

These are independent committees that put the rights, safety, dignity and well-being of research participants at the centre of their decision making. They make sure that patients are fully informed, and that they will be compensated if anything goes wrong. No research can be done in the NHS without their approval.

Monitoring trials and stopping rules Back to top

Before a trial begins, a data monitoring committee is usually set up to monitor patient safety and the effectiveness of the treatment during the trial.

The data monitoring committee can stop a trial if they are concerned that a new drug or treatment is causing harm to a person. For example, they can stop a trial if there are severe side effects. This is unlikely to happen in phase 3 or 4| studies because the new drug or treatment has already been extensively tested during phase 1 and 2 studies. Trials can also be stopped early if the results of the new treatment are much better than the standard treatment. The new treatment can then be used instead of the standard treatment so that everyone in the trial can benefit from it.

Insurance Back to top

The drugs used in clinical trials are made to the highest standards of purity and quality. Drug companies are insured so that if a patient is harmed by some unforeseen event due to the drug, compensation can be paid. It’s rare for patients to be harmed by trial drugs although some may cause unpleasant side effects.

Trials funded by the Department of Health, the UK Medical Research Council or medical charities may not have this kind of insurance, but a payment would be made if something did go wrong. All trials will have a legal sponsor. One of the sponsor’s roles is to make sure that there are arrangements, such as insurance, to protect those taking part against damage or loss. Individual NHS trusts are responsible for insuring themselves against damage caused by local studies. Research ethics committees would refuse approval for trials where there is no insurance or provision for compensation.