What is a Clinical Trial?

A Clinical Trial, Research Study or Protocol all mean the same thing.  Before a medication can be sold for the general use in the United States, it must meet stringent guidelines and standards set by the United States Food and Drug Administration (FDA). To meet these standards, a potential drug or medical treatment goes through several phases of testing (often over several years) with individuals who volunteer to participate in the clinical trial or research study. Every prescription drug, medical device and new medical treatment in the United States has been through this testing process. Each clinical trial involves hundreds and sometimes thousands of volunteers. Without volunteers for clinical trials there would be no NEW medical treatments, medical devices and prescription medications.



What are the advantages of participating in a clinical trial?

Rhode Island Mood and Memory Research Institute has its own laboratory so subjects do not have to travel to other facilities for testing. Most of the assessments completed for our various studies are done right here at our East Providence office. Subjects receive study related medical care at no cost to the subject or their insurance company. The medications that patients receive during the course of a trial may be a viable alternative to the course of treatment that a subject is currently under going. Clinical trials often include patient compensation for time and travel.  The quality, frequency, and level of care provided by a clinical trial most often exceeds a subject's expectations.

What can I expect from study visits?

Our first concern is always for the subject's health, privacy, and well-being. New medications are normally tested in four different phases. Each successive phase involves a greater number of people.  When being considered for participation, you will be thoroughly instructed as to what will occur in that particular trial so you can make an informed decision about your participation.  All clinical trials are different depending on the phase and the medical area being investigated. Some of the common assessments during participation may include laboratory testing, blood draws and urine samples, Electrocardiogram (ECG) collection, subject interviews with the study doctor or nurse, vital signs (Blood Pressure, Height, Weight, Pulse) and some form of patient questionnaires. Often MRI's, CT Scans or PET Scans are performed as well.  The cost of these assessments is provided for by the sponsoring pharmaceutical company and is never billed to the subjects' medical insurance company. There is no cost to the participant other than the cost of their time. The collection of data varies by each protocol or research study.



How are clinical trials regulated?

The overall governing body of clinical trials in the United States is the Food and Drug Administration (FDA). All clinical trials must follow stringent guidelines regarding patient safety, privacy, confidentiality, and ethics. All clinical studies are also overseen by an Independent Institutional Review Board (IRB) or an ethics committee. These committees are responsible for reviewing the ethics of clinical trials and are in place for patient safety. These boards review changes, monitor safety data, and grant approvals for all elements of clinical trials. The patient is well protected during their participation and is encouraged to ask questions so they can be informed throughout the trial.

If you have any questions about participating in a clinical trial please call our study staff at 401-435-8950



Visit us on Facebook!