What is a Clinical Study?
A clinical study is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug’s ability to treat a condition, its safety and its possible side effects.
How is a Drug Approved for Testing?
The U.S. Food and Drug Administration (FDA) typically must authorize a drug company’s proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans.
Who is the Institutional Review Board (IRB)?
The IRB is a group of healthcare professionals and members of local community which must review and approve a clinical study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of study participants.
Why should I participate in a clinical trial?
Clinical trial volunteers are an essential part of medical research. Volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of diseases that affect people and the development of new therapies. Volunteers are important to the clinical study phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications for a broad range of health problems.
What are the risks and benefits of clinical trials?
The potential risks and benefits vary from trial to trial. However, if you are interested in volunteering for a specific study potential risks and benefits will be explained to you prior to your consent to participate. You will also be able to ask any questions or concerns you have that are not addressed.
What Can I Expect?
A detailed description of the clinical study and what’s expected of you will be outlined in the consent form. Once you have enrolled in a clinical study, your study physician or research staff member will review your medical history, and you will receive a physical examination. You should feel free to discuss your medical treatment with your investigator or research staff member at any time during the course of your clinical trial. Study volunteers are usually assigned to a specific study group. Sometimes volunteers receive an investigational treatment or study drug, and sometimes volunteers will receive a placebo or a treatment already available. You, your physician and your research staff may not know who is receiving a placebo and who is not. It is important to take all your medication as prescribed, and that you keep all your scheduled visits.
What is Informed Consent?
Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical study. This process allows the volunteer to ask questions and to exchange information freely with the clinical research staff.
What are the costs?
There is never a charge for participating in a research study. Study medication, medical care, and laboratory care is provided at no charge to you or your insurance company. Qualified volunteers may also be compensated for their time and travel.
Can clinical research trial participants see their regular doctor?
Yes. Clinical research trials do not replace normal health care. In fact, study coordinators, with participants’ permission, may update the study participants’ personal doctors regularly.
How long do visits last?
It depends on the clinical trial. You would be provided this information once you have qualified for a particular study.
Can clinical research trial participants leave a trial?
Yes, research study participants may leave the trial at any time for any reason. If you choose to leave the study, you will have the chance to discuss other treatments and care with your own doctor or a doctor from the study. All study materials must be returned, and a termination visit must occur.
What if I have a problem?
If you have any type of questions or problems, you can contact us and a research associate or staff physician will be able to assist you.
What Happens After the Trial?
After a study is complete, all of the information is collected and analyzed. This information determines whether a study drug is working, whether it is safe and whether it has any side effects.