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What Are Clinical Trials?
When a new vaccine or drug is developed, it is important that it is tested in humans for both safety and effectiveness. Studies performed on humans are known as clinical trials. The operation of clinical trials is complex and is regulated by the Food and Drug Administration (FDA). Usually, the process starts with testing the safety in a small number of healthy adults. Once shown to be safe in this group, the vaccine or drug is tested for effectiveness and safety in a much larger group, usually adults. If successful, clinical trials are then conducted in targeted vulnerable populations such as children and the elderly. The FDA may license the vaccine or drug based on positive safety and efficacy data generated from the trials. Clinical trials may continue even after licensure to further demonstrate safety and effectiveness.
More information about Clinical Trials and answers to commonly asked questions, are available at ClinicalTrials.gov.
The Department of Pediatrics and Clinical Trials
Many Department of Pediatrics Faculty play an important role in clinical trials. Our utmost concern is for the safety of the infants, children and teens involved in the studies. The work done in our department has helped in the FDA licensure of vaccines that are now commonly given and help prevent death and illness in children every day. In addition, other recent highlights include work with antibiotics, antivirals, sepsis (severe life-threatening infections) and cancer treatments.
The Office of Pediatric Clinical Trials
The Office of Pediatric Clinical Trials has experience performing studies sponsored by either the Centers for Disease Control and Prevention, National Institute of Allergy and Infectious Diseases, or drug companies. The Office is a component of the UTMB Sealy Center for Vaccine Development. The Office of Pediatric Clinical Trials has a large portfolio of studies performed at all phases from the very first-testing-in-humans through post-licensure. The goal is to offer excellent service from the viewpoint of both the participant and the sponsor. Staff and investigators focus on presenting balanced information to insure that the informed consent process is precise, informative and interactive. They are very committed to assuring that subjects and their families fully understand the project, its risks, benefits, expectations and requirements.