ABOUT CLINICAL TRIALS
The professional staff at the Memory and Wellness Center can provide education and referral information to clients and families who are interested in participating in clinical trials aimed at testing new and more effective treatment options.
Clinical trials are usually conducted in four phases:
PHASE I - Trials involve small numbers of healthy volunteers and focus on drug safety and how the medication is absorbed into the body and then broken down and eliminated.
PHASE II - Trials involve as many as a few hundred volunteers with the targeted problem and focus on the effectiveness of the medication in treatment, as well as safety factors, dose level, and short-term side effects. After a Phase II trial, both the U.S. Food and Drug Administration (FDA) and the researchers know quite a bit about the new medication.
PHASE III - This step involves testing the medication in large numbers of volunteers that continues to test both safety and effectiveness in treating a particular illness. In many cases, the results of this phase will be substantial enough to provide the FDA with the documentation needed to approve the new medication so that doctors may prescribe it to their patients.
PHASE IV - Sometimes, following approval of a new medication, post-marketing studies, or clinical trials, this phase may be performed to follow a medication through its first several years of use to evaluate any long-term effects and discover new uses for the drug.
Clinical Trial FAQ’s
WHAT IS A CLINICAL TRIAL?
A clinical trial is a carefully designed study that is done with people like you who volunteer to receive investigational treatments under close supervision of a physician and other research professionals. Pharmaceutical and biotechnology companies develop the treatment and then select physicians, called investigators, who are qualified to conduct clinical trials.
The clinical testing of a new medication is a step-by-step process that ensures you receive careful monitoring throughout the study. All clinical trials are conducted with the approval of the U.S. Government’s Food and Drug Administration (FDA) and the oversight of an Institutional Review Board (IRB). IRBs are independent committees whose job it is to make sure your rights are fully protected and that you are not exposed to any unnecessary risks. On average, 12 years and millions of dollars of research are invested before a medication is made available to the public.
WHY SHOULD I JOIN A CLINICAL TRIAL?
The primary purpose of most clinical trials is to test the safety and effectiveness of medication. People volunteer to participate in a clinical trial for a number of reasons. Participation in research may allow you to try a new treatment before it is widely available. Through comprehensive evaluation, a clinical trial may offer a degree of assessment and monitoring that you might not get otherwise.
Medical, psychological and behavioral research are our best hope for better understanding of treatments for various illnesses. Although most who take part in research hope to benefit themselves, they may also simply wish to help others, which is a reward in itself.
Further, clinical trials often yield what is known as the “placebo effect,” a psychological phenomenon related to the expectations associated with a pharmacological or non-pharmacological agent being administered in a “blind” or “double-blind” procedure, where participants are not aware of what is being administered to them. The placebo effect, which is evidence-based, may mean indirect benefits, psychological, physical, and otherwise, to a clinical trial participant, based on expectations alone.
WHAT CAN I EXPECT IN A CLINICAL TRIAL?
Once you have volunteered for a study, you will receive a detailed description of your specific clinical trial and what is expected of you. Your history will be reviewed in detail and a thorough evaluation of your condition (including a physical exam and laboratory tests) will usually be performed.
You always have the right to discuss any questions you might have about your treatment with an investigator or any staff member at any time during the course of a clinical trial. As a volunteer, you have the right to leave a study at any time, and for any reason.
It is very important to recognize that participation in a clinical trial in no way replaces general medical care. Personnel involved in offering clinical trials should be willing to work with your health care providers to be sure that your participation in a clinical trial does not interfere with your general medical care.
WHAT HAPPENS AFTER THE CLINICAL TRIAL?
When a clinical trial ends, several things can happen. Sometimes, the pharmaceutical company continues to provide the study medication to those clients who are responding well; other times a client will stop receiving the investigational treatment and may have to wait for the medication to be made available to the public. The specific plan for each study is explained to you by the staff of the trial. Investigators should always explain what treatment options are recommended for each individual volunteer after a trial and help put a good plan in place.
The decision to participate in a clinical trial is a very personal one. Participating in a clinical research trial can be a very satisfying experience, allowing you to potentially help yourself now and others in the future. Without research, treatment cannot improve, and without those who take part, science cannot move forward.
To learn more about clinical trials available in your area, visit: