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If you were a participant in one
of these studies, you would be given a complete physical
examination by a physician. In addition, the results of a chest x-ray, an
electrocardiogram, and blood and serum laboratory studies would be
determined. Only after the results of these examinations were known and your
physical state qualified you for the study would you be allowed to enter
into a research program. You would be fully informed about any study in
which you might participate and would be asked to sign an informed consent
statement.
Studies are conducted on either an in-patient basis in a hospital or an
out-patient basis at the DRAC facility or in a physician's office. There are
strict controls on your medication and possibly also on your diet. You would
be observed by physicians, pharmacist, and nurses - people trained to
recognize drug effects. Because you might miss some time from work and have
transportation expenses due to the frequent visits to the study physician
that are required by the protocol, you would be paid for your participation.
Most of the studies conducted by DRAC are controlled studies in which a
portion of
the patients get a new drug, and a portion get either a positive control drug
(one previously shown to be effective and already approved by the FDA) or a
placebo (an identically-appearing pill that has all the formulation of the
test drug except the actual drug itself.) Placebo therapy plays a very
important role in drug research. If a drug company cannot show that their
new drug for a particular condition is more effective than a placebo then
that drug has very little chance of reaching your pharmacy.
A code to determine
whether a patient is taking a new drug, a positive control drug
or a placebo is used when double-blind studies are conducted. In these
studies neither the patient, DRAC, nor the physician conducting the study
knows what medication the patient is receiving. That information is
available, however, in sealed envelopes should the need for that knowledge
arise. This situation is necessary for the unbiased evaluation of
a new drug.
One would expect that those patients who get a satisfactory response are the
ones who receive the
actual test drug and those who get no relief receive the placebo, but that
isn't always the case. When the code is broken at the end of a study,
sometimes a person with a positive response is found actually to have
received the placebo.
After a new drug is shown to be more effective than a placebo, it is then
studied along with a drug that is
already on the market to see if the new drug is as good as, or better than,
a marketed drug, A new drug does not always have to be better than an
existing marketed drug to be approved by the FDA. The basic charge to the
FDA by Congress is that a new drug must be shown to be safe and effective
for a particular condition. The law does not require that a new drug be
better than one which is already available.
There are numerous complaints about the length of time it takes the FDA to
approve new drugs. The sooner testing can be completed, the sooner a new
drug may be placed on the market. Part of DRAC's service lies
in the fact that a large number of patients with a particular condition can
be entered rapidly into a research study. If a drug company wants 40
patients to be treated with a new drug for high blood pressure, arthritis,
or some other condition DRAC can enter those 40 patients into a study within
a matter of days or weeks by advertising for patients with certain medical
problems.
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