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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”

                    

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."