For patients considering participating in clinical trials of investigational drugs or therapies...
In an effort to develop safe and effective drugs or therapies for certain diseases, Procter & Gamble Pharmaceuticals and other pharmaceutical
companies often seek eligible patients to enroll in clinical trials. If you are a patient seeking to participate in such a trial, some basic
concerns you may have are briefly addressed in the following question and answer section. Further down the page are links to three web sites
containing the kind of in-depth information you will need before actually applying to participate in a particular trial.
Some answers to basic questions about Clinical Trials...
What is a clinical trial?
A clinical trial (also called a clinical study) is a medically supervised procedure in which investigational drugs are given to patients for a set
period of time while changes in the patients' disease and overall health are monitored through physical examinations and laboratory tests. Typically,
during the time patients are taking a drug, they make periodic visits to the doctors in charge of the trial. On these visits, patients usually provide
information about how they are feeling, undergo physical examinations, and are given diagnostic tests meant to measure how their condition is
responding to the drug. Clinical trials can vary in length from days to years, depending on how long it takes to measure the effect of the
investigational drug on the disease being treated.
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Why should I volunteer for a clinical trial?
Patients who volunteer to participate in clinical trials make important contributions to advancing the understanding and treatment of diseases. Without
patients willing to participate in such trials it would be impossible to develop ever more effective treatments for disease sufferers. Additionally,
patients who participate in clinical trials may benefit from the therapies being tested, although this is not always the case.
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What are the benefits and risks of participating in a clinical trial?
Participating in a clinical trial involves both benefits and risks. The principal benefit is that you may gain access to an effective treatment for your
disease that is not available to the general public. The main risks are that you may suffer one or more side effects from taking the investigational drug
or that you won't experience any improvement in your health as a result of your participation. Both the potential benefits and the potential risks will
be disclosed and discussed with you before you make a decision whether or not to participate.
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What if I receive a placebo?
Usually, not all patients in a clinical trial receive the investigational drug being tested for efficacy and safety. Some patients in the trial will receive either a placebo (sugar pill) or a control drug, which is a proven effective existing drug which is different from the investigational drug. A placebo is normally used where no proven effective drug exists to treat the disease or when the disease is mild enough that the patient would not be at risk of harm or irreversible injury while taking the placebo. Patients who enroll in clinical trials are assigned to drug treatments in a random way; that is, they cannot choose which drug - placebo, proven effective existing drug, or investigational drug - they will receive. Patients are not told which treatment they are receiving during the trial but generally receive this information after completing their participation.
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Can I quit a clinical trial before I finish?
All patients enrolled in clinical trials are free to discontinue participation at any time without penalty. However, before you take any action, it is
important for you to discuss your decision to drop out with the medical personnel supervising the trial.
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How can I find out if I qualify to be in a clinical trial?
A doctor, because he/she is familiar with a patient's disease and the medications currently available to treat it, can help a patient decide whether
receiving an investigational drug in a clinical trial is in their best interest. The patient's doctor may also know of clinical trials that would be
appropriate. Local newspapers and other media sometimes run ads seeking patients to participate in trials and the Internet is an excellent way to
both learn about and find clinical trials. However, having a certain disease is not the only requirement for participating in a clinical trial.
Patients must also fulfill other requirements related to age, sex, disease severity, general state of health, other medications being taken, etc.,
before they can be enrolled.
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Looking for sources of in-depth information on clinical trial participation?
From Test Tube to Patient: New Drug Development in the United States
This Food and Drug Administration (FDA) site provides patients with the information necessary to make an informed choice about participating in
clinical trials.
For more information click here
ClinicalTrials.gov
This site is a service of the National Institutes of Health. It provides especially comprehensive information for patients interested in
participating in clinical trials.
For more information click here
WomenCanDo.org
A site for women seeking comprehensive information on clinical trials
http://www.womancando.org
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