New Study Tackles Poorly Designed FDA Studies

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One size is a manufacturer’s dream, but it can lead to disaster in orthopedic medicine. Bodies come in every shape, size, disease and comorbidity state. To the extent that clinical trials are designed around homogeneous, not real-world diverse patient populations, how might that affect the efficacy of orthopedic and spine implants and instruments?

An ambitious and significant new study has looked back at 35 years of FDA authorized orthopedic device clinical studies and quantified the role that sex and race played in the clinical trial design.