Lessons Learned: What the BMP Trials Controversy Has Taught Us

ORS Clinical Research Forum examines “wrong turns”

Terry Stanton

That the Clinical Research Forum sponsored by the Orthopaedic Research Society (ORS) and devoted to “avoiding wrong turns” in the development of new products and therapies would include the issue of recombinant human bone morphogenetic protein-2 (rhBMP-2) is no surprise. In 2011, rhBMP-2 came into a less-than-flattering spotlight over questions not only about complications associated with its use—much of it off-label—but also about how the original industry-sponsored trials could have reported essentially no adverse events.

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