Advances in medicine and science are the results of new ideas and approaches developed through research. Research studies conducted with patients are called clinical trials. Central Baptist Hospital is involved in many clinical trials, including ones for the treatment of stroke. The purpose of a clinical trial is to study the effects and safety of a new medical treatment to determine if the treatment is better than, as good as, or not better than the known standard treatment.

Initially the new treatment is tested in the laboratory. Then tests are done on healthy people who volunteer to participate in studies. Conclusions are drawn from the information obtained, and it is determined whether the new treatment may help people with disease. Clinical trials are then conducted on patients who actually suffer from the disease. The information obtained from patients enrolled in clinical trials is examined for effectiveness and safety and any possible side effects.

Patients take part in clinical trials for a many reasons. Usually, they hope for benefits for themselves. They may hope for a cure of disease, a longer time to live, or a way to feel better. Often they want to contribute to a research effort that may help others.

Patients in a clinical trial are among the first to receive new research treatments before they are widely available. How a treatment will work for a patient can't be known ahead of time. Even standard treatments, although effective in many patients, do not carry sure benefits for everyone. Participation in clinical trials is completely voluntary. Patients should choose if they want to take part in a study or not, only after they understand both the possible risks and benefits.

The treatments in clinical trials can cause side effects and risks depending on the type of treatment and a patient's condition. Side effects vary from vary from patient to patient. Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though efforts have been made to find out what they might be.

Clinical trials have several procedures to protect the safety of people who participate in the study. Several groups have to approve of the procedures involved in every study. Two of these groups are the sponsor of the study (for example, the National Cancer Institute) and the Food and Drug Administration (FDA). A third very important group that monitors research is the Institutional Review Board (IRB).

Every study center, like Central Baptist Hospital, has an IRB that includes doctors, nurses, other healthcare providers, consumers, and members of the clergy who do not have a personal interest in the results of the study. They serve as neutral reviewers and ensure that the study is managed fairly and that no one is likely to be harmed by participating in the study. The IRB approves every study that is done at the study center. Not only does the IRB approve the study when it first starts, but it also monitors the progress of a study over time. The IRB has the authority to stop a study if the members believe that it is in the best interest of the patients participating in the study to do so.

All patients in a clinical trial are carefully monitored during a trial and followed up afterward. Different research studies have different follow-up requirements. Participation in a study may last for several days to several months. All of the requirements of a study are explained in a document known as an informed consent. All patients who participate in a study must sign an informed consent before any research procedures occur. An informed consent explains the purpose of the study, risks involved, potential benefits, what is involved in the study (what you have to do), and that participation is voluntary.

At some point while you are a patient, you may be asked to participate in a research study. Carefully consider the risks and benefits to participation. Don't be afraid to ask questions until you get all of the facts you need to decide. Your participation may help contribute to the study and the future development of new drugs, devices or medical treatment. For more information, contact the Clinical Research Center at (859) 260-4489.

Information adapted from "What Are Clinical Trials All About?" published by the National Institutes of Health, National Cancer Institute and Cardiovascular Research Clinical Trials Brochure by Darla Warren, ARNP, MSN.

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