People participate in clinical research for a variety of reasons.
People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free.
The patient’s rights and safety are protected in two important ways.
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Any physician awarded a research grant by a pharmaceutical company or the NIH must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay people, is charged with examining the study’s protocol to ensure that the patient’s rights are protected, and that the study does not present an undue or unnecessary risk to the patient.
- Second, anyone participating in a clinical trial in the United States is required to sign an “informed consent” form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
Patients Considering Participating in Clinical Research:
Should talk about it with their physicians and medical caregivers. They should also seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.
Other questions to ask:
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How long will the trial last?
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Where is the trial being conducted?
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What treatments will be used and how?
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What is the main purpose of the trial?
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How will patient safety be monitored?
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Are there any risks involved?
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What are the possible benefits?
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What are the alternative treatments besides the one being tested in the trial?
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Who is sponsoring the trial?
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Do I have to pay for any part of the trial?
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What happens if I am harmed by the trial?
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Can I opt to remain on this treatment, even after termination of the trial?
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Where can you get more information about clinical research?
More information about clinical research:
