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How Will Treatment in a Clinical Research Study Differ from Treatment Your Own Doctor Provides?

August 23, 2006

Clinical research often involves providing treatment. Yet, treatment research is different from the care that you would get from your own doctor. Usually, when you go to a doctor, you want help with a particular problem. You count on your doctor to do what is best for you. You know that anything your doctor suggests is meant to make you well.

A treatment research project, however, is different. The investigator wants to learn about your illness, and not just treat you. Of course, a researcher will try very hard to see that you benefit from the treatment research and that any risk will be small. Yet one goal remains the most important: learning how well a new treatment works for someone with your illness.

In research, the design of a study may call for standardized procedures. For instance, when a researcher studies a medicine, or drug, the research plan may require that only the drug under study be available to you. It may mean that you will receive it only in a fixed dose; that is, the researcher cannot tailor the amount of a medication to your immediate needs. Or, standardized procedures may mean that you will receive a medication only in one specific way for example, by a shot or as a pill.

In such a study, or drug trial, the treatment you will receive likely will be based on your random assignment to a particular medication or, sometimes, to an inactive pill (a placebo). You should be told what is known about the relative benefits and risks of each treatment used in the research study. You should also be told what is known about alternative treatments that might be given outside a research project. In contrast, treatment outside of a research study seldom uses random choice of treatment and never uses a placebo; your doctor will always prescribe a treatment that he or she believes would be good for you. However, situations remain where no one may know what treatment is best, and that is one instance where the importance of research is clear.

It should help to know that even investigational treatments are well-tested for safety before their use in a clinical study. Also, remember that you always can decide to withdraw from a study. You, or someone close to you, should know whom to contact if you want to do so at any time.

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