Clinical TrialsWhat are they and what should you expect if
you participate in one.
|Before any new drug is approved
by the FDA, it must go through an extensive research process called a clinical trial.
Clinical Trials are part of a multi-phased evaluation process utilized to determine the
safety and effectiveness of new medical treatments. Laboratory testing and pre-clinical
evaluation of new treatments may take several years before receiving approval to begin
studies in patient populations. The first studies (Phase I) involve small groups of
"Healthy" volunteers to determine how the medication is actually processed by
the body. If the medication continues to safely show potential benefit, small groups of
patients will be selected to evaluate various dosages (Phase II) to help determine how
much of the medication it may take to provide the maximum benefit while causing the fewest
side effects. With initial safety and effectiveness documented, the medication enters
large scale, multi-center, national or international evaluations (Phase III Clinical
Trials). These clinical trials require enrollment of hundreds of patients for whom the
medicine would be intended once final approval has been obtained. While each study may
only last a few months, the accumulation of sufficient documentation on the safety and
effectiveness of a medication in phase III evaluation may last years. Once the new product
has FDA approval clinical trials may continue in the form of Phase IV studies. Phase IV
trials are generally used for marketing comparisons and dosage modification.
There is a great opportunity for participation in the clinical trial process. Most of the
advertisements in local media are for Phase III studies. If you respond to a request to
participate in a clinical trial, be prepared to provide information about your current
health status. All questions you may have about your participation should be answered
prior to conducting any research related procedures. You may be asked to come into the
clinic to discuss the details of the study. All potential benefits and risks associated
with the study will be explained to in detail. Generally, potential benefits include free
medical care (e.g. physical exams, lab work, and office visits) for the condition being
studied. Medications utilized within the study are provided at no cost to the patient, and
a small monetary compensation is provided to participants at the end of their
The Institute of HealthCare Assessment, Inc. has several studies in need of volunteer
participants. If you would like more information click here.