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Drs. Aranda and Lieh Lai are testing a variety of drugs for proper use in children. |
One-size does not fit all when it comes to drug dosages, says Jacob Aranda, MD, professor of pediatrics and pharmacology. With $1.4 million from the National Institutes of Health (NIH), Dr. Aranda is establishing the Wayne State University/Detroit Medical Center Pediatric and Newborn Center for Clinical Pharmacology, where he will serve as principal investigator for a series of clinical trials that will help determine which adult-approved drugs are safe and effective for children and at what dosage. Thus, WSU is now a NIH Pediatric Pharmacology Research Unit (PPRU) and a key site of the NIH Network.
Although recent regulations by the Food and Drug Administration (FDA) require that all newly approved drugs be tested for children, approximately 85 percent of the drugs on the market have not yet been labeled for pediatric or newborn patients, said Dr. Aranda. As one of 13 centers selected to participate in this national trial, WSU will collaborate with the FDA, pharmaceutical companies, and other clinical testing sites to ensure proper labeling and education. The WSU NIH/PPRU will conduct studies on any drugs used in the newborn infant and child.
"Wayne State University’s already existing Pediatric Pharmacology Program comprise the bulk of this effort. Their past work will be greatly enhanced and invigorated with this boost from the NIH," said Dr. Aranda. "With this increased support, our faculty members and research teams can make great progress in advancing protocol development, clinical drug trials and research performance." The goal is to ensure that drugs used in children are safe, effective and available.
Mary Lieh Lai, MD, associate principal investigator, said although they need to gather data on a large number of drugs, the FDA has specifically developed a list of the 500 pharmaceutical agents which will take top priority in this research study. "The long-term goal is to eventually have all drugs labeled and approved for use in babies and children," she said.