What is a Clinical Trial?

A clinical trial is a method of testing different medications, treatments and 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, doctors' offices and clinics. The research services, medications and products received in most clinical trials should be free and in some clinical trials, study participants are paid to be involved.

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 or product being studied. The sample size is small, ranging from 10-20 participants.
Phase II Clinical Trials:
Determine safety and effectiveness of the medication or 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 of the medication, treatment or 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 or product has gone through testing phases, the FDA licenses those that are safe and effective. At this point, the medication, treatment or 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 that those that are determined unsafe or ineffective are not licensed.

Courtesy of the National Institute of Allergy and Infectious Diseases