Medical Devices for Children Often Tested Only in Adults
Authors find disconnect between clinical trials and ‘real world’
According to a new study led by investigators at Harvard Medical School, most medical devices that have been approved recently for use in pediatric patients weren’t tested in children first. Almost all of the devices had been evaluated only in people 18 years of age and older, the researchers found.
The study was published online in Pediatrics.
In 2007, the Pediatric Medical Device Safety and Improvement Act was passed to stimulate the development of pediatric devices.
The researchers identified all high-risk (i.e., class III) devices approved through the premarket approval or humanitarian device exemption pathways for therapeutic use in children between 2008 and 2011. The investigators collected information on clinical trial designs as well as on the age distribution of trial participants. They also identified FDA-mandated postmarketing trials.
The authors found that 22 devices were approved for use in children via the premarket approval pathway and that three were approved via the humanitarian device exemption pathway. Twenty-two (88%) of these devices qualified as pediatric despite minimum approval ages of 18 years or older. (The FDA's Center for Devices and Radiologic Health considers patients 18 to 21 years old as pediatric.) Most devices were approved on the basis of nonrandomized (59%), open-label (68%) studies with surrogate effectiveness end points (77%).
Overall, the authors found that 21 (84%) devices were not studied in patients less than 18 years of age. Postmarketing studies were mandated by the FDA for 19 (76%) devices, but only three (18%) required the enrollment of pediatric patients. Of these three studies, none was completed.
The authors point out that the FDA requires at least one clinical trial that shows a device is safe and effective before approving it for use in patients. However, clinical trials don’t necessarily have to include the same type of patients that will be getting the device in the real world.