What is a clinical research trial?
A clinical trial is the method required by the Food and Drug Administration (FDA) to test a new treatment or drug for a particular condition in human subjects. The clinical testing of a drug is a step-wise process mandated by the FDA before a new drug is approved. The trial is carefully designed to study whether or not a new drug can benefit patients with certain conditions. All clinical drug studies must be done with the approval of the FDA and oversight by an Institutional Review Board (IRB).
How does a clinical trial work?
A drug must go through many different phases of testing to prove that it is safe to use in patients and is effective to treat a specific medical condition. The first tests on any compound are usually done in animals. Next, the drug is given to a small number of volunteers (Phase I). If the drug appears safe, it is tested in a small number of patients with the disease the drug is intended to treat (Phase II). A Phase III study is the last step before a drug is approved by the FDA. It is designed to demonstrate that the drug is safe and effective in the patient population being treated.
Before a clinical trial can be initiated, the study must be reviewed by an Institutional Review Board (IRB). The IRB is a group of physicians, scientists, and lay people who review medical research in humans to ensure that the study volunteers are informed about the research and that their safety is being monitored.
Your safety is the number one priority in a clinical trial. It is important that you adhere to the instructions provided to you by the investigators. During the course of the study, you should notify the principle investigator if you move, become sick or hospitalized, or for any other reason you think is relevant.
What is a controlled clinical trial?
Many times, it is necessary to do a controlled clinical trial (comparative trial). This type of study is when one group of patients gets the experimental treatment while a similar group gets only standard of care treatments. The group that does not receive the experimental treatment is called the control group and many times will receive a placebo (inactive treatment). To avoid biased data from the investigators, many studies are double-blind. In a double blind study, neither the patient nor the investigator knows whether the patient is receiving active treatment or placebo.
What is informed consent?
Informed consent is a process by which you are fully informed of the nature of the study. This includes your responsibilities, study procedures, potential risks and benefits, and that this information has been explained to you and all your questions have been answered. It has been mandated by the FDA that you sign an informed consent document to indicate your willingness to participate in the study before any study specific procedures/tests occur.
What are your rights?
As a potential study participant, you have the right to:
- Refuse to participate or withdraw from participation at any time.
- Ask questions and have your questions answered to the best of the investigator’s ability.
- Obtain a copy of the informed consent document.
- Be informed of any new findings related to the study that may alter your willingness to participate
Why are clinical trials important?
By participating in a clinical trial, you will help provide information to physicians about new treatments that may help your condition. It is possible that you will receive no benefit from participating in the study; however, others who suffer from your condition may benefit from what is learned in this study and perhaps be lead to new treatment option.
What will happen after the study is completed?
Your participation in the study will continue for a duration specified in the informed consent document. After all patients have completed the study and all information has been collected and analyzed, the investigators will review the data. This information will determine the safety and effectiveness of the experimental treatment. If the study involved a new drug or device, the data will also be reviewed by the FDA.
As a study participant, you may, in some cases, find out whether or not you received study medication. This information may or may not be released to the investigators by the sponsor companies.
The process of getting new treatments approved by the FDA for use in humans will vary widely based upon the results of the study, phase of the study, and review by the FDA. The process of getting a new drug approved takes several years to complete.
Who can I contact for more information?
You have the right and are encouraged to ask any questions concerning the potential and/or known hazards of this study any time during your participation in this trial. If you have any questions in the future, you should contact the principle investigator of the study, whose number is listed in the informed consent document.
In addition, if you have any questions about your rights as a research subject, you can contact the Chairperson of SIU's Institutional Review Board at 217-545-7602 or the Center for Clinical Research at 217-545-9700.