General Information About Clinical Trials: What, How & Why?

Clinical Trials
What Is A Clinical Trial?
How Are Clinical Trials Conducted?
Why Are Clinical Trials Important?
Why Would Someone Be Interested In A Clinical Trial?

Clinical Trials

Research studies conducted with subjects are called clinical trials. This information is for you, your family and friends, to explain what clinical trials are and to help you make a decision about entering a trial. This information is meant to supplement what The Center for Health Behavior Research (CHBR) staff tells you. It provides answers to questions asked most often about clinical trials.

We hope this information will help to explain how clinical studies are designed and carried out. You may decide not to take part in trial. The decision to enter a clinical trial is always up to you.

If you are interested in participating in an upcoming clinical trial, please complete the following Subject Interest Questionnaire or call 301-405-0128 and leave a message. Someone from our office will contact you for further information.

What Is A Clinical Trial?

A clinical trial is a study conducted with subjects usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to treat various medical conditions. The search for effective treatments begins with basic research in laboratory studies. The best results of that research are tried in studies involving subjects, hopefully leading to findings that may help many people.

Before a new treatment is tried with subjects, 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 subjects. With any new treatment there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us find out if a promising new treatment is safe and effective. 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 basis for building new, hopefully better treatments. Many new treatments are designed based on what has worked in the past, in efforts to improve on this.

Only subjects who wish to, actually take part in a clinical trial. You may be interested in or asked to enter a trial. Learn as much as you can about the trial, before you make up your mind.

How Are Clinical Trials Conducted?

The investigators who conduct a clinical trial follow a carefully designed treatment plan called a "protocol." This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of subjects as well as to answer research questions.

Some clinical trials test one research treatment in one group of subjects. Other trials compare two or more treatments in separate groups of subjects who are similar in certain ways, such as the extent of their dependence on nicotine. This way, the treatment groups are alike and the results from each can validly be compared.

One of the groups may receive placebo (containing no medication) treatment so the new treatments can be directly compared to it. The group receiving the standard treatment is called the "control" group. The control group is followed as often and carefully as the "treatment" group.

One of the ways to prevent the bias of a subject or doctor from influencing study results is "randomization." This means the subject is selected by chance to be in one group or another. Most clinical trial studies are "double-blind" meaning that neither the subject nor the investigator knows which treatment the patient is receiving.

Knowledge gained from research studies with subjects has been essential to overall progress. Such studies have led to diverse and effective treatments for assisting individuals with various medical conditions.

Why Are Clinical Trials Important?

Advances in medicine and science are the results of new ideas and approaches developed through research. New treatments must be proven to be safe and effective in scientific studies with a certain number of subjects before they can be made widely available. Through clinical trials, researchers learn which approaches are most effective. This is the best way to test a new treatment. A number of standard treatments were first shown to be effective in clinical trials. These help us find new and better treatments.

Why Would Someone Be Interested In A Clinical Trial?

People take part in clinical trials for many reasons. Usually, they hope for benefits for themselves. Often they want to contribute to a research effort that may help others. Based on what researchers learn from laboratory studies, and sometimes earlier clinical studies and standard treatments as well, they design a trial to see if a new treatment will improve on current treatments. The hope is that it will. Often researchers use standard treatments as the building blocks to try to design better treatments.

Many trials have turned out to be better than standard treatments; others have either been not as good as or no better than the treatments already being used. Although there is always a chance that a new treatment will be disappointing, the researchers involved in a study have reason to believe that it will be as good as, or better than, current treatments. Subjects 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 subject in a trial can't be known ahead of time. Even standard treatments, although effective for many individuals, do not carry sure benefits for everyone. Subjects should choose whether to take part in a study, only after they understand both the possible risks and benefits.

Subjects who take part in clinical trials that do prove to be better treatments, have the first chance to benefit from them. All subjects in clinical trials are carefully monitored during a trial and are followed up afterwards. They become part of a network of clinical trials carried out around the country. In this network, physicians, investigators and researchers pool their ideas and experience to design and monitor clinical studies. They share their knowledge from many specialties. Subjects in these studies receive the benefit of their expertise. At research centers, subjects receive care from a special research team.