Findings from University of Missouri Provides New Data about Orthopedics (The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices)
By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA Investigators publish new report on Orthopedics. According to news reporting originating in Kansas City, Missouri, by NewsRx journalists, research stated, "The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015."
The news reporters obtained a quote from the research from the University of Missouri, "Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, > 70% of studies were deemed 'unclear' in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors."
According to the news reporters, the research concluded: "This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices."
For more information on this research see: The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices. Journal of Bone and Joint Surgery-American Volume, 2017;99(9):711-719. Journal of Bone and Joint Surgery-American Volume can be contacted at: Journal Bone Joint Surgery, 20 Pickering St, Needham, MA 02492, USA (see also Orthopedics).
Our news correspondents report that additional information may be obtained by contacting J.P. Barker, University of Missouri, Sch Med, Dept. of Orthopaed Surg, Kansas City, MO 64110, United States. Additional authors for this research include S.D. Simon and J. Dubin.
Keywords for this news article include: Kansas City, Missouri, United States, North and Central America, Government Agencies Offices and Entities, Orthopedics, University of Missouri.
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