Supporting clinical research

What are clinical trials?

Any new treatment must be extensively tested to check that it works, is safe and doesn't have unacceptable side effects.

A new treatment may not be better and could even be worse than existing treatment, for example. Most often the treatment is a drug, but it could be a medical device, a surgical or physical procedure, a therapy or an intervention such as health promotion.

New treatments have to be thoroughly tested.  For example, a new drug, is investigated first in the laboratory.  If it looks promising, it is carefully studied in people. Approval has to be sought from the regulatory authority of the member state in which the trial is to be conducted. In the UK, this is the Medicines and Healthcare products Regulatory Agency (MHRA).

The researchers conducting the trial must draw up a plan or protocol which will include information such as who and how many will take part in the trial, what question does the trial aim to answer, what treatments will be compared and how the results will be collected.

The protocol then undergoes an independent scientific review and must also be approved by an ethics committee before the trial can go ahead.
These checks are to ensure that the trial design is sound and that the research will respect the rights, dignity, safety and well being of the participants.

Are there different types of trials?

There are 4 phases of clinical trial. Each treatment being tested has to go through all these phases before it can be used.

• Phase 1:Trials look at whether a trial treatment is safe or has any harmful effects. The research team will also find out the best dose to use.
• Phase 2: Trials look at how well a treatment works. Only a treatment that has got through these 2 phases goes into phase 3 testing.
• Phase 3: Trials test a new treatment against the existing standard treatment. If it gives better results, it may become the new standard treatment.
• Phase 4: Trials are carried out after a drug has been licensed. They collect information about side effects, safety and the long term risks and benefits of a drug.

The researchers may look at the impact a treatment has on you, for example, how often you have to travel to the hospital.  Studies of impact and side effects are sometimes called quality of life studies.  Most well planned trials include a quality of life study.

Usually, a new treatment has to go through a few phase 3 clinical trials before doctors are confident enough to accept it as the new standard treatment. One good trial result could happen by chance or because a trial was not very well designed.

This is not likely if several trials have the same results. Since May 2004, all trials are now required by UK law to meet the standards set by the European Union Clinical Trials Directive. This is designed to ensure that all trials will be carried out to the same standard wherever they take place in Europe.

Not all clinical trials will result in new and better treatment. Some will discover that the treatment being tested does not work. Or that it has side effects that are much worse than with existing treatments. But, this information is also useful for researchers and doctors, and in the end for patients.

Licensing

If a medicine is granted a licence it can be sold in the UK. The licensing body in the UK is the MHRA. It must ensure that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness.

In arriving at a decision whether or not to grant a licence, the MHRA often seeks independent expert advice from bodies such as the Medicines Commission and the Committee on Safety of Medicines. Experts will take into account the nature of the illness to be treated as well as the duration, dosage and formulation of the treatment. Evaluating the beneficial effects of a treatment against the possible harmful effects is complex.