Clinical trials addressing high-risk pediatric medical devices used in children.
By Pooja Toshniwal PahariaOct 2 2023Reviewed by Lily Ramsey, LLM In a recent study published in Pediatric Research, researchers performed a scoping evaluation of data from clinical trials addressing high-risk pediatric medical devices used in children.
About the study In the present study, researchers from the Coordinating Research and Evidence for Medical Devices initiative examined clinical trial data on using hazardous medical-grade devices in children. They investigated clinical trial techniques and designs that used medical devices in the high-risk category in children as the study intervention.
The study comprised clinical trial findings on high-risk medical devices in children, including pre- and post-market clinical studies. Based on the FDA, the category included class III items implanted to support or sustain life or entail a potentially unreasonable disease or injury risk. Results A total of 1,692 records were screened, of which only 99 trials were considered for analysis. Most trials were performed in multicenter settings , of which 73% were conducted in a single country, whereas 27% included multinational participants.
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