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Clinical Trials: A Guide for Patients

Could Any Problems Arise From Participating In a Clinical Trial?

This will depend on the type of treatment and the patient's condition.

Because the drug or device being studied is new, all of the risks and side effects of the treatment are not known at the beginning of the clinical trial. Since this is the case, there may be unknown side effects, as well as hoped-for benefits. It is important to note that most treatments, as well as the disease or condition itself, have potentially unpleasant effects.

Patients will be informed of any known side effects they could experience, as well as any side effects that occur or become known while they are participating in the trial.

How Would My Treatment Be Different If I Participated in a Clinical Trial?

  • You may receive more examinations and tests than are usually given for your particular condition. The purpose of these tests is to follow your progress and collect study data. Of course, tests can carry certain benefits and risks or discomforts of their own. Although they can be inconvenient, these tests can assure extra observation.
  • Depending on the type of clinical trial, you may be asked to stop or change the medication(s) you are currently taking. You may also be asked to change your diet or any activities that could affect the outcome of the trial.
  • Some clinical trials are double-blind, placebo-controlled. This means that the clinical trial participants may receive the real drug or an inactive substance that looks exactly like the drug (called a placebo). Neither the participant nor the researcher will know which drug they are receiving. This is done to make certain that the real drug is effective.
  • Clinical trial participants are willing volunteers. Even though patients may be asked by their doctors to take part in a clinical trial, it is up to the patient to make the final decision, or to pull out of the trial if they want to.

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