Workshop to Focus on Trial Designs for Pediatric Cardiovascular Devices

The FDA and NIH will sponsor a public workshop on clinical trial design for pediatric cardiovascular devices from 8 a.m. to 5:30 p.m. Sept. 30 at the Moscone Center in San Francisco. The workshop will focus on efficient, pragmatic trial designs and statistical analysis methods conducive to overcoming the challenges in developing cardiovascular devices for children. The agency will use the information gathered at the workshop to develop guidance on optimal designs for pediatric cardiology device trials.