Controlled tests to determine the effectiveness of new treatment approaches, also called clinical research trials. Clinical research studies can involve new devices such as deep brain stimulation (DBS), new surgeries, or other new procedures for treating medical conditions such as Parkinson’s disease. A clinical pharmacology trial is a type of clinical research study that evaluates the effectiveness of new drugs and is under the oversight of the U.S. Food and Drug Administration (FDA). Clinical research trials follow medical, legal, and ethical guidelines established by federal regulations. Although there is inherent risk in participating in a clinical research study, these guidelines strive to establish an environment in which participant safety and well-being are the defining parameters.
At any given time, there are thousands of clinical research trials taking place at government agencies, research facilities, medical centers and hospitals, and health care practice groups throughout the country. The website www.clinicaltrials.gov, produced and maintained by the National institutes of Health (NiH), provides extensive information about clinical research trials for people who might be interested in participating in them. The website also lists the trials that are currently seeking participants.
The NiH identifies four primary classifications of clinical research trials:
• Treatment trials—studies that are exploring new treatment options, such as new drugs and stem cell therapy, for people who already have a disease such as Parkinson’s.
• Prevention trials—studies that seek ways to prevent people from acquiring or developing diseases such as Parkinson’s, such as coenzyme q-10 supplementation and neuroprotective therapies.
• screening trials—studies that attempt to find practical ways to identify the presence of a disease such as Parkinson’s in its earliest stages, particularly before symptoms signal that the disease has already caused damage.
• Quality of life trials—studies looking for ways to improve and sustain the well-being, aside from health status, of people who have chronic or degenerative diseases such as Parkinson’s.
Regardless of type, clinical research trials all include certain key elements. A clinical research trial starts with a protocol, which is the researchers’ statement of what they expect to find through the study, what benefits and risks are possible for participants, and how the trial will be conducted in details. All participants must receive and sign a statement informed consent, which explains the protocol and the participant’s rights and responsibilities.
Clinical research trials have both benefits and risks, and it is important to understand both fully as well as to have realistic expectations when beginning the trial. Most of the time, the research team provides whatever medical care is necessary as a result of participation in the trial although participants typically continue to receive care through their regular health care providers. People with Parkinson’s who enroll in clinical research trials should notify their doctors and make sure that they do not make any changes in their care without first talking with the researchers.
