Review of clinical trial settings of drugs commonly used in primary care and approved between 2005 and 2012

Excerpt

The approval of new drugs by the US Food and Drug Administration (FDA) depends on demonstration of their safety and efficacy through clinical studies. To best inform clinical practice, these pivotal trials would ideally be conducted in care settings where the drugs will ultimately be used. For example, drugs used to treat diabetes mellitus are most frequently prescribed to patients by primary care physicians in office-based settings, yet trials used to support their approval may be conducted among patients receiving care from endocrinologists, in acute care settings and/or in non-US-based healthcare delivery systems 1. Our objective was to characterize the patient populations and settings of pivotal trials supporting FDA approvals from 2005 to 2012 for new drugs used for indications most commonly treated in the primary care setting. …