What is a clinical study?
Clinical research studies (also called clinical trials) are critical for identifying new ways of treating medical conditions and diseases. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
During a clinical study, researchers may find out whether an investigational drug:
- Is safe to take
- Has manageable side effects
- Works the way it is expected to
- Works less, the same or better than other drugs or placebo
- Behaves in the human body in a certain way (e.g. where is it transported, how quickly is it removed from the body, is there more of it in some organs over others, etc.)
Types of clinical studies
Clinical studies take place over four different phases to check that the potential new treatment is well tolerated and that it works in the anticipated way.
Development of a new drug starts with pre-clinical testing, which is the testing phase before it goes into humans. Then the most promising drugs move on to clinical studies with people. Development of a new medicine typically goes through four phases of testing:
- Phase 1: This is the first time a new medicine is tested in humans, usually healthy volunteers, to see how safe and effective the drug appears and how it is metabolized in the body (e.g. where in the body it goes, how quickly it is removed from the body). These are studies with a smaller number of people, typically between 10 and 100.
- Phase 2: After successful phase 1 testing, the medicine is evaluated in a larger number of people (typically 100 to 500). For most drugs, this is the first time it gets tested in patients to see if it is a promising candidate to treat the disease for which the drug is being developed, and to find out what the best dose is.
- Phase 3: These are larger studies (typically 500 to 5000 patients) to confirm that the drug really works and is safe to take. When a drug has passed the first 3 phases of clinical development, it may be ready for review by regulatory bodies for medicines, who decide whether the drug should be made available to the wider public.
- Phase 4: Even if a drug is approved for public use, it is still monitored. This is achieved through Phase 4 studies in which researchers examine how well the drug works over a longer period of time and in a larger number of patients. These can be several thousand to ten thousands of patients.
The Orchestra Study is a Phase 2 study.
It can take some time, usually years, before a new treatment is made available after a Phase 3 clinical study. That’s because there are rigorous processes to ensure the study drug really does show a benefit, and for the regulatory authorities to check and assess the safety and effectiveness of the potential treatment. You can certainly ask your study team and your own doctor about how this process is going.
Who is involved in clinical studies?
Clinical studies take place in private practices, clinics, hospitals or surgeries, which are called study sites. During a clinical study, you will be supported by a dedicated study team that typically consists of nurses and doctors and can also include study coordinators or other staff involved in the study.
Is participation in a clinical study voluntary?
It is completely up to you to decide if you want to take part in a clinical study. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors or negatively affect benefits to which you are entitled.
By joining a clinical study you might have the opportunity to:
- Better understand your condition
- Have your condition closely monitored
- Help others living with Parkinson’s disease in the future
Interested?See if you qualify