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Home/Legal & Regulatory and Reimbursement/New Study Tackles Poorly Designed FDA Studies
Legal & Regulatory and Reimbursement Premium

New Study Tackles Poorly Designed FDA Studies

January 24, 2025 1 min read Premium comments

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Poorly Designed FDA Studies
Source: Shutterstock
StudiesPremium#fda#centerfor devicesandradiologicalhealth#underrepresenteddemographicgroups

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?

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Elizabeth Hofheinz, M.P.H., M.Ed.
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