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How to Enroll in a Drug Study

There are several ways in which patients and their physicians can learn of clinical trials in which they may want to take part. Research subjects are frequently recruited through newspaper ads placed by participating hospitals. Such ads explain what kind of patients are wanted and how they can get further information about the study. Specialists are likely to be aware of new experimental drugs in their field of practice and know which of their colleagues are carrying out clinical trials.

Patients who are thinking about participating in drug test- ing should talk to their physicians, who may in turn con- tact a drug company or teaching hospital for information. (FDA is not permitted to release information about ongoing clinical studies unless the drug sponsor agrees or the information is already public knowledge.) Protecting the right and safety of people who participate in drug testing is a major concern shared by drug sponsors, clinical investigators and FDA. Each design, or protocol, for a clinical trial has to ensure that no participant will be subjected to unnecessary risk or be deprived of needed care merely to find out if a new drug is effective. Once an investigational drug has been shown to save patients lives or prevent their disease from causing irreversible damage, patients in clinical trials cannot be denied that therapy by being given a placebo. On the other hand, once they're properly informed, patients may agree to take part in placebo-controlled studies when their only risk would be discomfort. (For more information about protecting research subjects, see "Protecting 'Human Guinea Pigs"' in the December 1986-January 1987 FDA Cotisiitiier). Those contemplating enrolling in a drug study should be aware of quackery disguised as legitimate clinical research. How can a person tell whether he or she is volunteering for bona fide medical research or is about to be victimized by medical fraud'? A prudent first step would be to ask your doctor about the investigator, the institution, and the drug. If you decide to get in touch with the researchers, ask to see the informed consent form. Insist on meeting with someone in authority to explain the project to you in terms you can understand. Ask questions, and if you are not completely satisfied with the answers, don't agree to participate. Don't sign anything that waives your rights if you are harmed in the course of the study. No legitimate drug sponsor or investigator requires that. Be very suspicious if you are asked to pay for an investigational drug. FDA can allow drug sponsors to recover research and development costs by selling investigational drugs, but only in the later stages of clinical trials and only when it's understood that the sponsor intends to bring the drug to market.

This is not the usual pattern. Ask to see evidence that FDA has both approved the study and given approval of the investigational drug to be sold. See if the drug used in the "clinical trial" is being advertised as effective treatment for people who have the disease. Such advertis- ing violates FDA regulations. If you become aware of what appears to be health fraud masquerading as clinical research, call the nearest FDA office. It's listed in the phone book under U.S. Government. Not everyone may be willing to become a clinical research subject. But, as an industry scientist pointed out, participants in phase 2 and 3 clinical trials are very likely to get excellent care at the hands of people who really know their business. And they just might be involved in an important advance in treatment for their disease."

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