Clinical trials What is a clinical trial?
NHS Forth Valley Diabetes Service
Clinical trials help researchers test the safety and effectiveness of new treatments and compare them with current ones. Clinical trials rely on the participation of volunteers. Some studies will recruit volunteers with no health conditions, and others will need people who have the condition that the drug aims to treat.
Each trial will have its own set of criteria for participating. This may include location, age, gender, length of time since diagnosis, severity of reaction to gluten and other medical conditions.
What research happens before a clinical trial? The first stage of drug development is to understand the disease process and identify a target.
It can diabetes diagnosis nhs years of laboratory work to produce a potential drug that can be tested in humans. Sometimes a drug that has already been licensed for one disease is tested for any benefits and any side effects in another disease.
Phases of a clinical trial For new treatments to be approved and licensed for medical use, they must go through a series of phases: Phase I: The treatment is trialled for the first time on a small group of healthy volunteers to check for side effects and find a safe dosage. Phase II: The treatment is tested on a larger group of people who have the condition the treatment is targeting.
It is usually compared against a placebo non treatment.
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Phase III: This phase assess how effective the new treatment is and how it compares to existing treatments. The treatment is tested in hundreds or thousands of people and can then be licensed for medical use.
Phase IV: This involves following people over a series of years to see how the drug performs in the long term. In total, it can take years to develop, test and license a new treatment. Regulation of clinical trials A government agency called the Medicines and Healthcare products Regulatory Agency MHRA has to review and authorise a clinical trial of a new medicine before it can begin.
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All medical research involving people in the UK has to be approved by an independent research ethics committee. Blinding in clinical trials If you take part in a trial you may be given a new treatment, placebo non treatment or an existing treatment and most often you and the investigator will not know which you have been given.
What might be involved in a clinical trial for a treatment for coeliac disease? Clinical trials exploring new treatments for coeliac disease will most likely involve eating gluten for a short period of time to cause an immune response.
Anyone considering taking part in a clinical trial should not be afraid to ask questions of the investigators and to ensure these have been fully answered to their satisfaction before consenting to take part.
If you sign up to take part in a clinical trial, diabetes diagnosis nhs can chose to stop taking part in the trial at any point without giving a reason. Further general information on clinical trials can be found on the NHS Choices website.
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