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If
patients qualify for a particular research study, their clinical
course is carefully monitored. Those who are receiving regular medical
attention are encouraged to notify their regular physicians of their
participation in DRAC'S research program. At a patient's request, DRAC will
gladly furnish copies of their records to the patient or to his physician.
DRAC accepts patients for short term drug studies but does not provide any
long term care beyond completion of a particular drug study. Most of the
studies are relatively short, lasting from one to 3 or 4 months.
If the drug DRAC is studying is not effective in a particular patient,
the drug may be withdrawn. lf an intolerable side effect occurs the drug is
withdrawn and the patient is dropped from the study. Patients are also free
to withdraw from a study at any time for their own reasons.
The side effects generally observed by patients
taking a new drug are the same ones usually reported by patients taking a
similar drug that is already on the market. Sometimes it is difficult to
tell if a reported side effect is due to a drug's effect or due to the
diseased condition of the patient.
Other studies conducted by Drug Research and Analysis Corporation include
pharmacokinetic and bioequivalence studies. These studies are usually done
in young, healthy male volunteers, who after taking a single dose of a drug,
have a series of blood samples taken at periodic time intervals to measure
the blood levels of the drug administered. These blood levels are used to
determine such pharmacokinetic parameters as peak blood levels of the drug,
how long after dosing the peak blood level occurs, the half-life of the drug
(how long it takes for the blood level to drop 50% or what it is at any one
time), and how much of the drug is absorbed into the blood. These various
parameters are used to determine whether a particular generic drug produces
equivalent blood levels to a brand name product of the same drug.
In order to provide an incentive for arthritis patients to donate all or
part of their compensation for participation in DRAC's arthritis research
studies to additional research, Dr. Frazer has issued a statement to all
participants that for any part of the stated compensation a patient wishes
to give to The Arthritis Foundation, Drug Research and Analysis will
contribute an additional 50% of the total gift.
When Dr. Frazer was asked how he became involved in drug research, he
stated it was a natural progression of his professional career. He has
earned both the Bachelor of Pharmacy and Doctor of Pharmacy degrees and was
previously employed by the Bureau of Medicine of the Food and Drug
Administration at their headquarters in Washington, D.C. and by an
international research-oriented pharmaceutical company as Assistant Director
of Clinical Pharmacology.
People who would like to participate in DRAC's research studies should
visit its office located at:
1758 Park Place, Suite 200, Montgomery, AL,
36106, or call their office at: 334.265.2700.
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