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What are clinical trials?

Clinical trials are an essential part of the medical development process. Clinical research provides us with vital information about our bodies and how various medical substances can affect them. Only by using information given to us by clinical research can we develop safer, more effective medications. Although these new therapies can now successfully treat a large number of medical conditions, there are still many illnesses that modern medicine cannot treat.

As a result, new therapeutic methods are always being sought. Clinical researchers are continuing to study, test and develop new therapies. However, before a new medication can be made available to the public, it must travel a very long way. It takes approximately 12 years and £600 million to test, develop and approve a medication. First, the most promising substances are chosen and tested in a research lab. Then clinical trials consisting of four phases test these substances with human volunteers.

The Medicine and Healthcare Regulatory Authority (MHRA) defines a clinical trial as the following:

"A clinical trial is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies."

Who authorizes clinical trials in humans?

Clinical trials are regulated and controlled by law.  All clinical trials testing "substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans" must apply with the Medicine and Healthcare Regulatory Authority (MHRA) for authorisation.

The MHRA makes sure that safe and effective drugs are available to the British population by monitoring the use of medicines within the UK. It also publishes the drug analysis prints (DAP) which contain complete listings of all suspected adverse drug reactions or side effects that have been reported by healthcare professionals and patients to the MHRA

Before a trial is allowed to begin, researchers must submit a protocol (a detailed plan of their proposed research) to a research ethics committee. Safety is rigorously enforced by a number of government authorities, which include:

• Medicine and Healthcare Regulatory Authority (MHRA)
• National Research Ethics Service (NRES) of the National Patient Safety Agency
• European Medicines Agency (EMEA)

Who supervises ethical considerations?

Before the initiation of a clinical trial, applicants are counselled by their local ethics committee. The National Health Service (NHS) states that:

"Researchers have to prepare an information leaflet about their trial for patients. The research ethics committee checks that this is clear and accurate.

All those who take part in a trial are given the leaflet, with an opportunity to take it away and discuss it with friends and relatives.

Until a research ethics committee approves a clinical trial, researchers cannot ask any participants to join it.

The committees are independent both of the researchers whose work they are reviewing and of those who pay for the research."