Guide for patients
What are clinical trials and how do they work?
Clinical trials can help a great many patients by making it possible to discover new medicines, improve existing drugs, and find new uses for the drugs that are already available.
Clinical trials help us to answer specific questions about investigational drugs, such as whether or not they are effective, whether they are an improvement over other treatments, and whether they are safe.
Developing a new drug can take over 10 years, which may be too long for patients who are awaiting treatment. Though long, this period is essential to guaranteeing that all drugs are subjected to rigorous testing.
Before it is brought to market, a new drug must go through the usual stages of clinical research development, called phase I, phase II, and phase III.
Clinical trials are usually performed in a hospital or medical research center using healthy volunteers or patients. Normally, it is not necessary for the volunteers or patients to stay in the hospital or research center throughout the study period, although the effects of the drug are closely monitored by highly qualified staff.
In order for a developmental drug to go on to the next stage, it must be proven to be safe and potentially beneficial for patients. Once a drug has passed the tests included in all of these phases, it is sent to the health authorities for authorization to market the drug to the general public.
Who can take part in a clinical trial?
Thousands of people participate in clinical trials every year. Some studies need healthy people as volunteers, while in other trials the volunteers must have a specific disease or disorder. All volunteers are important, as without them the development of new drugs couldn't go on.
Clinical, or medical, researchers conduct clinical trials by following the study protocol. Researchers are usually doctors, nurses, pharmacists, or other health professionals.
The good clinical practice standard indicates that clinical researchers must have the training and experience necessary to assume the responsibility for executing the study and for ensuring that it is performed properly, be fully qualified as indicated by applicable regulations and provide proof of said qualifications in the form of an updated CV or other relevant documentation upon request by the study sponsor or institutional review board.
All possible measures are taken throughout the clinical trial to guarantee the safety of volunteers and patients. For this purpose, a number of tests are performed, including blood tests, physical examinations, or other procedures such as CT scans or ECGs. In addition, patient reports are taken into consideration.