Q. What is a Research Study?
A. A research study (also known as a clinical trial), is a study in which people volunteer to test a new medical treatment. By conducting research studies, we learn whether new medications are safe and effective. Also, currently approved medications may undergo testing for the treatment of new indications. Research studies are needed to develop new medications for many conditions, including: Hypertension, Diabetes, Cholesterol, Arthritis, Migraine’s, Reflux, Insomnia, Alzheimer’s, etc. Once a new drug is found to be safe and effective, it may be approved by the FDA for doctors to prescribe.
Q. Why should I join a research study?
A. By joining a research study you will not only gain access to new research treatments but also make a very important contribution to medical research.
Q. Who can participate in a research study?
A. All research studies have certain requirements which must be met for eligibility. These requirements may include factors such as age, gender, type of disease, current medication use and other medical conditions.
Q. How does a research study work?
A. First you will meet with the study team who will explain and discuss the study with you. Once you decide to join the research study you will receive an informed consent document to read and sign.
Q. Are the research studies supervised?
A. Definitely yes. Research studies are supervised by qualified doctors and researchers who work as a team with other doctors, nurses and health care professionals.
Q. What is the informed consent?
A. The informed consent describes what you can expect from your participation in the study such as the frequency of the study visits, what procedures will be done during the study, any potential benefits and possible risks of participating in the study. After reading it carefully you may discuss it with the study doctor and coordinator. You should ask them questions or request additional information. Once you are satisfied and decide to join, you will be asked to sign the informed consent document.
Q. Once I sign the study starts?
A. After signing the informed consent, you will be required to provide some more information in order to make sure that you meet the requirements for study enrollment. Once eligibility is confirmed you will be enrolled in the study.
Q. What kind of information will you require from me?
A. Different studies have different requirements, but generally during the study you can expect:
Q. What should I pay attention to while considering the study?
A. Before joining the clinical trial, pay attention to the following topics:
Q. Can I consult with my family before deciding?
A. Of course. You may request a copy of the informed consent and discuss it with your physician, family and friends.
Q. Are research studies safe?
A. Researchers, doctors, and other health professionals conduct research studies according to strict rules set by the Food and Drug Administration (FDA). The FDA created these rules to protect clinical trial participants and to make sure they are treated as safely as possible. Research studies are also overseen by medical ethics groups to ensure that study participants are treated appropriately.
Q. What are the benefits of participating in a research study?
A. While participating in the clinical trial you will gain access to in-depth study related materials, you will be entitled to medical care, gain access to new research treatments and above all, you will help others by contributing to medical research.
Q. Can I leave a research study once it has begun?
A. Yes you can. You are free to leave the trial at any time. If you do decide to leave, you should let the study team know and tell them why you are leaving the study. Early study termination procedures will take place to ensure your safe exit.
Q. Where can I get more information about research studies?
A. There are several organizations that offer information about research studies. Here are a few:
