How are clinical trials regulated?

Once researchers have proven a new treatment to have a strong chance of being better than what is currently on the market to treat a specific disease, they must gain permission from the MHRA to begin a clinical trial.

The MHRA (Medicines and Healthcare Products Regulatory Agency), is a government agency in the UK that protects participants during a clinical trial by ensuring the trial is conducted safely.

The governing body which regulates clinical trials in the US is called the FDA, Food and Drug Administration. Approvals must also be gained from an ethics committee to make sure the trial holds up to ethical standards, such as the protection of clinical trial participants, informed consent, and transparency of trial conduct.

The ethics committee of a trial will consists of independent groups of people including; doctors, nurses, other healthcare professionals and members of the public. They review all patient related documents to check whether it is written clearly, and if the information presented is sufficient to make an informed decision about participation.

They also check whether the potential benefits of the study medicine are likely to outweigh the risks – thus, the trial can only go ahead if it has been approved by an ethics committee. Other approvals may also be needed depending on the type of trial and the treatment.

National and international regulations and policies also exist to protect the rights, safety and well-being of individuals taking part in clinical trials.

Good Clinical Practice (GCP) is a set of international ethical and scientific quality standards that informs the law in every country and sets the minimum level of standard for conducting clinical research.

Non-compliance of these standards is against the law, and the MHRA assess compliance with the regulations by conducting inspections – they can either be routinely performed or triggered by suspected violations. If the patients are not adequately protected during a clinical trial, the MHRA has the authority to completely shut down the study.

The sponsor is accountable for the initiation, management and financing of a trial, and they play a key role in providing adequate study oversight.

On-site monitoring visits are conducted to ensure compliance with GCP, the protocol and the regulatory requirements, and although we are based in the UK, we also work with sponsors from the US. This means both the FDA and MHRA can inspect our site, and since marketing authorisation for a new treatment can be provided nationally by the MHRA or centrally by the European Medicines Agency (EMA), inspections can be requested by the EMA.

If you have any questions about the regulatory aspects of our studies, and would like reassurance that what you are about to take part in is safe, you can contact us on

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