What is a clinical trial?   Research studies conducted with patients are called clinical trials. A clinical trial is a study conducted with individuals, usually to evaluate a new medication or treatment procedure. Each study is designed to answer scientific questions and to find new and better ways to treat diseases or prevent illnesses. Before a new treatment is tried with patients, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. But this early research cannot predict exactly how a new treatment will work with patients. During a trial, more and more information is gained about a new treatment, its risks, and how well it may or may not work. Standard treatments, the ones now being used, are often the base for building new, hopefully better, treatments. Many new treatments are designed on the basis of what has worked in the past, in efforts to improve on this.

              Why are clinical trials important?  Advances in medicine and science are the results of new ideas and approaches developed through research. New treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available. Through clinical trials, researchers learn which approaches, treatments or medications are more effective than others.

                What is it like to be a patient in a clinical trial?  For some people, myths and fears of experimentation or of being a guinea pig come with the idea of clinical trials. And, surely, there are fears of the unknown. Understanding what is involved can ease some of the anxiety. Patients in a clinical trial, for example, receive their care in the same places that standard treatments are given--at hospitals, clinics, or doctors' offices. Doctors, nurses, social workers and other health professionals from many different specialties may help care for you. They are working together for the patient's good. There is consideration for the patient's privacy and well-being. Patients who join a research study will be watched closely and data on his or her case will be carefully recorded. The patient may receive more examinations and tests than are usually given. (These are to follow the patient's progress as well as to collect study data.) Of course, tests can carry certain risks and benefits or discomforts of their own. Although they can be inconvenient, these tests can assure an extra ounce of observation along the way. During the course of a study, if it is clear that a treatment is not in the patient's best interest, he or she will be removed from the study.

                Who is eligible to participate in a clinical trial?  Every clinical trial is designed to answer a set of research questions. A patient who fits the guidelines for a trial may be eligible to take part. Only individuals who wish take part in a clinical trial. An individual may be interested in or asked to enter a trial. Individuals may be referred to a trial by their doctor. Some patients learn about trials from other sources such as advertisements or referrals from families or friends who are participating in the trial. In any case, a patient must have a reasonable understanding of his or her role in a research study and be freely willing to take part in it. Ask what can be expected when taking part in a trial.

                What is an informed consent?  An informed consent is a patient's voluntary confirmation of willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the patient's decision to participate. Informed consent is documented by means of a written Informed Consent Form that contains relevant information about the trial and that is signed and dated by the patient or the patient's legally acceptable representative.

                What is done to safeguard participants?  The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated or federally funded (at least in part), with built-in safeguards to protect patients. These safeguards include regular review of the protocol (the study plans) and the progress of each study by researchers at other places. For example, federally funded and federally regulated clinical trials must first be approved by an Institutional Review Board (IRB) located either locally or at designated areas around the country. IRB's, designed to protect patients, are made up of scientists, doctors, clergy and other people from the local community. An IRB reviews a study to see that it is well designed with safeguards for patients and that the risks are reasonable in relation to the potential benefits. Any well-run clinical trial, whether federally supported or not, is carefully reviewed for medical ethics, patient safety, and scientific merit by the research institution. Every study should provide for monitoring the data and the safety of patients on an ongoing basis.