Before a medication or new device for treatment of medical issues is available to the public, the United States Food and Drug Administration (FDA) must review and approve the medication or device for public use. The FDA does this to learn more about the product and make sure it is effective and safe.
To get FDA approval, the company that makes the medication or device is required to conduct clinical research studies. The company will ask people to volunteer for clinical research studies. In these studies, volunteers are given the investigational medication or device and are evaluated by study doctors and staff members. After clinical research studies are completed, the company submits the study information to the FDA. The FDA reviews this information and decides if the investigational medication or device can become available to the public.
Clinical research studies are carried out under the strict supervision of fully qualified doctors, nurses and other healthcare and scientific professionals. Additionally, the Institutional Review Board (IRB), an independent ethics committee comprised of doctors, scientists and members of the community, must also approve the conduct of clinical trials. The main concern is safeguarding safety and rights of study participants.
WHY PARTICIPATE? By being a part of a clinical trial, volunteers can help move research forward. As a participant in a clinical trial, volunteers are making a substantial contribution to finding new and better treatments that may help other patients in the future.
Scientists work constantly to find better ways to treat diseases, but improved treatments can never become a reality without testing in clinical trials with human volunteers. Without the help of volunteers, finding better medicines for devastating disorders is practically impossible.
Some other benefits of participating in a clinical research study include:
Participants may gain access to cutting edge treatments and expert medical care
Any medical exams, tests and/or procedures that participants receive as part of the study will be provided at no cost to them
Free meals and care for the duration of the in-clinic stay
Patients may receive monetary compensation for their time, travel and participation for the duration of the study
Parexel is one of the newest members of the Parkinson’s Resource Organization Wellness Village under the category of Clinical Trials. If a volunteer is interested in learning more about our research studies and finding out if they qualify, go to the Parkinson’s Resource Organization Wellness Village under the category of Clinical Trials and click on PAREXEL.