By Nadege T. Gunn, M.D.
1. What is clinical research?
If you suffer from a disease that lacks an approved treatment, a clinical research study offers investigational medication to volunteers who are suffering from these conditions. These medications are carefully studied for safety and effectiveness.
2. Will I be a guinea pig?
The simple answer is NO. Before the drugs are ever tried in humans, they are tested rigorously in both animal and simulated human models.
3. Will I be paid any money?
As a clinical trial participant, your time and commitment to advancing medicine is highly appreciated. In most cases, you will be compensated for time and travel.
4. Can I change my mind about participating?
Clinical trial participation is entirely voluntary. You can withdraw at any time.
5. Could I get a placebo?
A placebo is often referred to as an “inactive” medicine or a “sugar pill.” To know if the actual or active medication is working, we must also evaluate those who do not get the medication. However, by being a part of a clinical trial, your chances of getting a medication that could improve your health condition are higher than if you do not participate at all.
6. Why should I participate in a clinical trial?
Because you are a hero and could save a life. Clinical trials do not recruit enough people from Black, Hispanic, or ethnic minority groups. When this happens, we cannot be sure that the drug will work as well in people who were not represented in the clinical trials.
7. Could I be harmed by participating in a clinical trial?
There are risks involved in clinical research, as there are with available drugs and devices.
Because these medications are new, some of the side effects may not be well known. However, most related adverse reactions are temporary and will go away when the study drug is discontinued.
Each study is different, but before you participate you will be given a document called an Informed Consent to review. This document will list all known and possible side effects from the drug(s) and/or study procedures. You will have ample opportunity to review these with the study physicians and have all your questions answered. You may withdraw from a study at any time and are not obligated in any way to participate or remain in a trial.
8. Who authorizes these studies and who do I call if I feel my rights are being violated?
The studies undergo rigorous approval processes by the Food and Drug Administration to ensure the studies are fair, necessary, and appropriate for humans. Also, the Investigational Review Board ensures the rights of human subjects are a priority. You can call the IRB anytime you have concerns about your safety or wellbeing in a clinical trial.
Nadege T. Gunn, M.D., of Waco, is medical director and president of Impact Research Institute. She is a gastroenterologist and hepatologist who focuses mainly on finding therapies for liver-related illnesses. Dr. Gunn is also a Certified Principal Investigator by the Association of Clinical Research Professionals. She is a fellowship-trained gastroenterologist and board certified in both internal medicine and gastroenterology. She has a broad clinical research and community practice background. Dr. Gunn is a member of Prosper Waco’s Access to Health Care working group.