What are clinical trials?
A clinical trial is a research study carefully designed to evaluate the effects of a medication, medical treatment or device. Participation in a clinical trial is entirely voluntary and will only take place once all the relevant information has been discussed with you by the research team. Participation may involve using the product on trial, or being part of a control group. The control group are given a placebo or an approved currently available treatment. All participants are carefully monitored throughout the study and all relevant data is collected and recorded. These trials measure the ability of a medicinal product to treat a condition, any possible side effects and ensure that the product reaches the safety standards, set by government agencies around the world. Clinical trials are an important part of the research and development process, essential when making new medications available.
Possible Benefits and Risks
People with diabetes may benefit from taking part in a clinical trial in a number of ways. The monitoring of your diabetes and general health is usually more frequent than it would be in normal practice. You may also benefit from access to the latest diagnostic tests and treatments for diabetes. As you are likely to be in regular contact with your research team, you may learn more about your condition and improved ways of managing it.
It may be that you receive no personal benefit from participation. It is possible you may experience some side effects from the treatment. The possible risks and benefits vary according to each particular trial design and treatments. Your study doctor and nurse will be available to discuss this with you in more detail, before you agree to participate in a specific study.
Who runs the Trials?
We carry out our clinical trials in partnership with fully qualified doctors and nurses around the UK in hospital clinics or GP surgeries. These doctors and nurses will be fully responsible for your care if you choose to participate in any of our research studies. All clinical trials must conform to globally approved scientific and ethical standards before they can proceed. Novo Nordisk trials are conducted in accordance with the Declaration of Helsinki, an international standard describing the rights of patients participating in clinical trials. All Novo Nordisk studies in the UK are also reviewed and approved by the Medicines and Healthcare Regulatory Agency (MHRA), NHS National Research Ethics Service and the NHS Trust for the area where the research will take place. During the trial Novo Nordisk works closely with the research site, to ensure that the study is running correctly and that all participants are being cared for satisfactorily. In addition the Medicines and Healthcare products Regulatory Agency (MHRA) are authorised to inspect either Novo Nordisk, or a research site, at any time to ensure that the clinical trial is being conducted correctly. Additionally, all Novo Nordisk clinical trials are fully conducted in accordance with ICH Good Clinical Practice (GCP), which is an international ethical and scientific quality standard for the conduct of trials.
E.D. Kennedy, et al., Networks offer new opportunies for diabetes research, Prim. Care Diab. (2009) Vol. 4, Issue 1, Pages 3-8 (http://www.primary-care-diabetes.com/article/S1751-9918(09)00117-X/fulltext)