Researching the safety and effectiveness of new drugs is more challenging in children than adults. Congress sought to boost studies involving pediatric patients by creating legislation that provides economic incentives and adds requirements for such research. Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, a new report from the Institute of Medicine, provides an independent assessment of several aspects of the studies carried out under this legislation, including the ethical challenges and the timeliness and usefulness of the clinical data that has been generated.
Advance copies will be available to reporters only beginning at 11 a.m. EST Tuesday, Feb. 28. The report is embargoed and not for public release before 10 a.m. EST Wednesday, Feb. 29. To obtain an embargoed copy, contact the National Academies’ Office of News and Public Information; tel. 202-334-2138 or e-mail firstname.lastname@example.org. More information on the study is available at http://www.nationalacademies.org/hmd/Activities/Children/PediatricStudiesBPCAPREA.aspx.