Skip to content

    Clinical Trials

    Font Size
    A
    A
    A

    Topic Overview

    (continued)

    How do clinical trials work? continued...

    After you are accepted by the clinical trial and you give your consent to take part:

    • You will be given a structured program to follow.
    • You will have a schedule of tests, doctor appointments, and treatments.
    • You may be asked to keep a diary of your experience during this time.

    Doctors, nurses, social workers, and other health professionals may be part of your treatment team.

    Be sure to carefully follow instructions. If you don't know what you are supposed to do next, call your doctor. Or call the person responsible for your trial.

    A medicine or treatment must go through three phases before it is approved for use by the U.S. Food and Drug Administration (FDA).

    What happens when the clinical trial is finished?

    After a clinical trial is completed and the results are studied, the FDA decides whether to approve continued development of the medicine. If the medicine that you received remains in development, you may be able to get more doses as an extension of the study.

    If the results of the clinical trial show that the new medicine or combination of medicines works much better than standard treatment, the new medicine may become available to the general public.

    Your treatment team may continue to check on you after your trial is over.

    What are the risks?

    You should be fully informed about the possible risks of the trial before you agree to participate.

    • Although the purpose of trials is to find new and better treatments, the new treatment may not work as well as standard treatments.
    • You may have unpleasant, serious, or even life-threatening side effects from the treatment.
    • The treatment may not work for you.
    • The trial may require more of your time than standard treatment. You may have to:
      • Make more trips to the study site.
      • Have more treatments.
      • Receive your treatment in a hospital.
      • Take more medicine more often or at very specific times.
      • Keep a written diary of your experience.

    How is your safety protected?

    Every clinical trial in the United States must be approved and monitored by an institutional review board (IRB) to make sure that the risks are as low as possible and are worth any potential benefits.

    The ethical and legal rules for medical practice also apply to clinical trials. Most clinical research is regulated by the U.S. government, with specific rules to protect the participants. Clinical trials follow a carefully controlled study plan (protocol) that explains what everyone will do in the study. During the clinical trial, researchers report the results of the trial at scientific meetings, to medical journals, and to government agencies. Your name will remain secret and will not be mentioned in these reports.

    1 | 2 | 3

    WebMD Medical Reference from Healthwise

    Last Updated: November 14, 2014
    This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.
    Next Article:

    Clinical Trials Topics

    Hot Topics

    WebMD Video: Now Playing

    Click here to wach video: Dirty Truth About Hand Washing

    Which sex is the worst about washing up? Why is it so important? We’ve got the dirty truth on how and when to wash your hands.

    Click here to watch video: Dirty Truth About Hand Washing

    Popular Slideshows & Tools on WebMD

    disciplining a boy
    Types, symptoms, causes.
    fruit drinks
    Eat these to think better.
    embarrassed woman
    Do you feel guilty after eating?
    diabetes supply kit
    Pack and prepare.
    Balding man in mirror
    Treatments & solutions.
    birth control pills
    Which kind is right for you?
    Remember your finger
    Are you getting more forgetful?
    sticky notes on face
    10 tips to clear your brain fog.
    Close up of eye
    12 reasons you're distracted.
    Trainer demonstrating exercise for RA
    Exercises for your joints.
    apple slices with peanut butter
    What goes best with workouts?
    Pink badge on woman chest to support breat cancer
    Myths and facts.

    Women's Health Newsletter

    Find out what women really need.