Safety in clinical trials
Understandably, anyone who enters a clinical trial will want to know that it’s safe for them to do so. There are a number of ways people are protected before and during a trial.
Medicines and Healthcare products Regulatory Agency (MHRA)
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The UK’s MHRA makes sure trials meet international standards of good practice, which are there to protect the people taking part. All serious side effects must be reported.
Research Ethics Committees
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All research in the UK involving people, whether done in the NHS or the private sector, has to be approved by an ethics committee. These are independent groups 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 are compensated if anything goes wrong.
The committees are often based at local hospitals and must be made up of a mixture of health professionals and other non-medical people. They often include patients, lawyers and members of the public.
Monitoring trials and stopping rules
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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’re 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 trials because new drugs or treatments are extensively tested during phases 1 and 2.
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.
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 harm caused by local trials. Research ethics committees will refuse approval for trials where there is no insurance or provision for compensation.