Did you know…the first clinical trial is believed to have taken place aboard the sailing ship HMS Salisbury in 1747? Surgeon mate James Lind divided 12 men with scurvy into six pairs and experimented with different remedies. The pair treated with citrus fruits made an impressive recovery, leading to the cure of the illness. More than 270 years later, clinical trials and the invaluable medical research they produce continue to lead to useful drugs that improve lives, including the lives of little patients.
Every May, Clinical Trials Day celebrates the enormous benefits clinical trials and clinical research professionals around the world bring to public health and medicine. Paidion, the only CRO (clinical research organization) in the United States specializing in pediatric clinical research, marked the day by noting the advances in medical studies designed to improve the lives of children.
According to Paidion Founder and CEO Barry Mangum, children are no longer “orphaned” by the drug development world. FDA’s first Pediatric Rule in 1994 was rescinded when pharma companies sued, but Congress pushed back with 1997 legislation requiring drug development for most children. The landmark 2012 FDASIA legislation (Food and Drug Administration Safety and Innovation Act) mandates that drugs developed for adults must also be developed for all children, even neonatal patients. This was a big step forward for children, and it’s what Paidion specializes in. “Children are not little adults,” Mangum said. “Because of the maturation of various organ systems, it requires special attention to determine the proper dose and dosing interval. Safety is another major concern requiring medical expertise within any company developing compounds for use in children.”
“I believe that most parents do not realize that over 90% of all drugs used in children today have never been studied in children,” Mangum explained. “In many cases pediatricians have been using the adult doses scaled down to the pediatric patient. This method of dosing has resulted in children often either receiving not enough or too much medication to treat the disease.”
“Paidion is doing the right kind of research for the right reasons,” said Jennifer Price, Senior Director of Clinical Data Management. “Paidion wants to do research the right way, not the way it has always been done,” she pointed out. “There are methods and technologies we can use to collect data that will decrease the time for approval and minimize the number of children we need to study to provide safe, effective treatments. We believe in finding the right treatment for babies and children, and not just modifying products used by adults. It’s what we know, it’s all we do.”
Mangum believes this commitment makes Paidion a logical partner for companies and universities working on pediatric medicine research. “Children matter to us,” Mangum concluded. “We have over 40 years of experience in pediatric clinical drug development and take special pride in knowing that we are the only clinical research company in the United States dedicated to children. Our mission is to ensure that the tiniest babies receive the best care possible from the medications they receive. If we do not perform drug trials with care and accuracy, the patient population will suffer. Our goal is to bring new and important medicines through regulatory approval so that all knowledge can be disseminated, resulting in better outcomes for children.”
PHOTO CUTLINE: Paidion, the only CRO in the US specializing in pediatric clinical research, recently celebrated Clinical Trials Day and the impact of medical studies and clinical research professionals on public health and medicine with its team. From left to right: Barry Mangum, Jennifer Price, Nathan Taylor, Laurie Dunn, Gretchen Yonish, Terri Pearce, Destrey Roberson, Betsy Reid, Marianna Bui, Danielle Addison, Bonnie Phillips and Grecia Esparza.