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Clinical Trials Research

What is a clinical trial?

A clinical trial is a method of testing different medications/treatments/products to determine which ones are safe and effective. There is a difference between being treated by your health care team and clinical trials. The primary goal of a health care team is to help the patient stay healthy. While a study participant's health is an essential part of clinical trials, the primary goal is to find out which treatments work for the most people.

Clinical trials can be funded by pharmaceutical companies, the National Institutes of Health (NIH) and other funding sources. They can be conducted at universities, doctor's offices and clinics. The research services and research medications/products received in most clinical trials should be free and in some clinical trials, study participants get paid to be involved.

On the Long Road to Approval

Prior to the Food and Drug Administration (FDA) approving medications for sale by pharmaceutical companies, experimental medications must go through phases of testing to determine their safety and effectiveness.

Phase I Clinical Trials: determine safe dosage levels of the medication/treatment/product being studied. The sample size is small ranging from 10-20.

Phase II Clinical Trials: determine safety and effectiveness of the medication/treatment being studied. There are a greater number of participants with a sample size ranging from a few dozen to a few hundred.

Phase III Clinical Trials: determine the long-term benefits from the medication/treatment/product. There are a large number of participants with a sample size ranging from a few hundred to a few thousand participants.

Once the medication/treatment/product has gone through testing phases, the FDA licenses the ones that are safe and effective. At this point the medication/treatment/ product may be prescribed by your physician. Please note that not all drugs go through all phases of testing before they receive approval from the FDA and the ones that are determined as unsafe or ineffective are not licensed.

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Last updated August 6, 2001 (sas)