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How does a laboratory discovery evolve into a vaccine to prevent disease or a treatment for disease?
The following is a simplified version of the complicated process that usually takes years to complete.
Working in the laboratory, a St. Jude researcher discovers a drug, vaccine, or other product that might benefit humans. Many tests are run to ensure that it has the desired effect on lab samples.
The product is tested on laboratory animals to find out if it does what is expected. It also helps researchers find what doses should be tried in humans.
The product is made following the U.S. government’s current Good Manufacturing Practices (cGMP). St. Jude has a cGMP Facility on the northwest corner of the campus. After the product has been made, the St. Jude Quality Assurance unit tests and approves it.
During a Phase I clinical trial, about 10 patients are tested to find the best dose and any toxic effects of the product. A Phase II trial involves about 100 patients. It helps decide if the product actually has the desired effect, such as curing the disease with few side effects. A Phase III trial tests the product on hundreds or thousands of patients. In these trials, researchers will see if the product can cure the disease it targets on a regular basis.
The U.S. Food and Drug Administration approves and licenses the product for use. The vaccine or product is distributed and marketed all over the United States.
If you have questions about clinical research at St. Jude, please call the Research Participant Advocate at 595-4644. If you are outside the Memphis area, dial toll-free 1-866-583-3472 (1-866-JUDE IRB). The Research Participant Advocate ensures that patient families understand basic rights regarding clinical research.