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NEJM endorsement of Real World studies

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Date: 13/5/2011


This week, James Ware, Professor of Biostatistics at the Harvard School of Public Health in Boston and Mary Beth Hamel, writing in the New England Journal of Medicine (NEJM) further endorse the need for good quality pragmatic trials. They say that although randomised clinical trials provide essential, high quality evidence about the benefits and harms of medical interventions, many such trials have limited relevance to clinical practice.

Investigations are often framed in ways which fail to address patients' and clinicians' actual questions about a given treatment and because of the need to prove efficacy the patient population is homogenous with limited and defined treatment regimens - far from the real world population in which the therapy is subsequently given.

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