Issue 8.13
Have you ever wondered about clinical trials? What they are? Who volunteers? What do I experience when part of a clinical trial? These and many other questions I have fielded in my 1000 years of managing clinical trials.
Clinical trials are the study of investigational medications for a certain disease or condition. Before a medication is made available through prescription it is studied to make sure it is safe and effective. The study may be a new medication or an already approved medication that is being approved for a new use. The Food and Drug Administration (FDA) require all prescription medication to go through this type of study. In a study, the researchers and doctors will be comparing the study medication against a standard treatment medication or a placebo. Many studies require that neither the subject nor the doctor know whether the subject is receiving the study treatment, the standard treatment, or in some cases a placebo.
To do this we need volunteers to work with us and the doctors. Many people volunteer because they feel that they receive greater personalized attention during their office visits; which is true because a volunteer is more closely watched and cared for during the study.
People that participate in clinical trials get study medication, study-related medical exams, blood work, other study-related tests i.e. ECG, eye exam, x-ray and, in some cases diet and lifestyle counseling at no charge. Sometimes compensation is available and the screening is confidential. Participating in a clinical trial may give your physician an alternative to the ongoing treatment of your particular disease or condition. Possibly reducing or eliminating the financial burden that may otherwise incur.
As a volunteer you will meet with a study doctor, you will discuss your medical history, do a study-related physical exam and blood work to see if you qualify for the clinical trial. If you qualify for the study and desire to participate you will be given information about the study. This is known as “informed consent”. The informed consent document is NOT a contract and you can leave the study at any time, for any reason.
Clinical Trials are carefully designed and reviewed by independent review boards (ethics review) before they are ever started. Doctors and other health professionals who run these studies comply with all federal regulations. With this in mind you know that great care is taken to protect the volunteers as well as your contribution to medical science.
We currently need volunteers for studies in Type II Diabetes, Celiac Disease, Rheumatic Arthritis, and Vaccines for children ages 12-23 months: MMR and children 4-6 yrs for: MMR.
Please call me today to be part of scientific history. Susan Bilanzich of Chrysalis Clinical Research (435) 656-1704.