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Innovative treatments are tested in clinical trials.
Learn more about Clinical Trials
What is a clinical trial?
Why test new treatments?
Sometimes, the treatment tested is not new, but the way it is given, the dosage or the combination with other treatments differ. It may also be a treatment already used for one type of condition. Before using it for another type of condition, however, a new study has to be done to see whether the treatment is safe and works for the new type of condition.
What are the main possible benefits of participating in clinical trials?
– The new treatment may have a higher efficacy than the standard treatment
– Participants will be watched carefully by health professionals according to a protocol
– The clinical trial is an experiment and its results will be helpful for all. It will either allow other patients to benefit from a new and useful treatment or avoid researchers to continue their research on a useless or harmful treatment. The results will also help researchers to understand a disease better.
What are the main possible risks of participating in clinical trials?
– The new treatment may have some side-effects that can range from minor and reversible side-effects to life-threatening side-effects. Some side-effects can also appear weeks, months or even years later and include damages to important organs such as heart or kidney or the development of a second condition or disease
– In phase III clinical trials you usually do not know if you receive the new treatment or not.
How can I participate?
What are my rights as a patient?
What are clinical trial phases?
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.
Phase 1 trials aims to determine the safety of a new medication. Usually the medication is given to a few healthy volunteers (usually about 20 to 80 people) and the trial can last for several months. In addition to its safety, this phase also aims to investigate the most appropriate dosage which can be given without any serious side effects and the ideal way for the medication to be administered, for example orally or intravenously.
During phase 2 studies which can last from several months to 2 years, the new medication is given to a larger group of people (usually between 50 and 300 participants) who have the condition or disease for which the medication is being developed. The primary aim for this trial phase is to determine the effectiveness of the medication. More information on the dosage and side effects is also gathered during this phase. Results from phase II studies provides the background for designing the methods for Phase III studies
Phase III trials are carried out in a much larger population, typically involving between 300 to 3000 participants for a period of 1 to 4 years. This phase aims to determine the effect of the new medication in a specific population. Here the new medication is compared to the “standard of care treatment” (i.e. the current treatment for the disease/condition which is being investigated) or a placebo (i.e. a substance that has no therapeutic effect) to ascertain if it is more effective and has less side effects. For this purpose, phase III trials are usually “randomized”, meaning the group of patients chosen to receive either the new medication or standard treatment/placebo happens by chance. It is also common to have these studies double-blinded, which means that neither the participant nor the investigator knows which medication the participant is taking.
Phase IV trials are conducted after the new medication has been approved by the Food and Drug Administration (FDA) or the European Medicine Agency (EMA). This is carried on thousands of volunteers who have the disease condition. Phase IV trials focuses provide more information about the side effects and the safety of the medication, the long-lasting effects and how well the medication works when used extensively in a wider population.
(Source : http://www.nlm.nih.gov).