Clinical Trials

What 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 participation.

The Institute of HealthCare Assessment, Inc. has several studies in need of volunteer participants. If you would like more information click here.



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