Whilst the overall aim of carrying out a clinical trial is to improve treatment, the patient’s safety is the primary concern and
will never be compromised in order to achieve the trials’ aims.
Trials are heavily regulated and reviewed to ensure that the scientific rationale behind the trial is sound and of potential benefit to the patient.
We have summarised the role of a few of the various groups involved in ensuring patient safety;
Independent Scientific Review – The plan for a clinical trial is set out in a ‘protocol’.
The protocol is reviewed by a number of independent scientists and experts before the trial is agreed.
Independent Data Monitoring Committees (IDMC) – The committee is set up before a trial begins and
as the name suggests, the members are independent of the trial. Their role is to monitor the patient safety and the
effectiveness of the treatment during the trial. They are able to access interim (before the end of the trial) results
to decide if a clear result has been reached and to ensure that the trial is safe to continue. The committee is able to
recommend that a trial is stopped early if there are too many severe side effects or 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.
Trial Steering Committee (TSC) – This committee includes independent members as well as the researchers
leading the trial, doctors and nurses. Their role is to ensure that the trial is running well and can advise the researchers on the
continuation of it. They may also review any major changes to the protocol and in this case must approve any changes before submission to an ethics committee.
Ethics Committees – No research can be carried out in the NHS without approval from an ethics committee.
These are independent committees that protect the rights, safety, dignity and well-being of trial participants.
They ensure that patients are fully informed and that they will be compensated if anything goes wrong. The committees
will include members of the public, researchers and healthcare professionals.
The committee also need to approve any changes to a trial protocol. Researchers must tell the ethics committee
if participants experience unexpected and serious side effects during the trial.
Medicines and Healthcare Products Regulatory Agency (MHRA) – The MHRA are responsible
for making sure that trials meet international standards of good practice. Research must report all serious side effects to the MHRA.
National and International Guidelines – There are national and international laws and directives in
place to ensure that safety is the primary concern for organisations carrying out research. All organisations that run trials
must ensure that they have insurance in place in case people are harmed during a trial.
The Research Governance Framework sets out standards (designing, conducting, recording and reporting
of clinical trials) of good Clinical Practice in the conduct of health research.