Clinical and Prophylactic Trials With Assured New Treatment for Those at Greater Risk: I. a Design Proposal
Finkelstien, Michael O.
American Journal of Public Health 1996 May; 86(5): 691-695
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Clinical and Prophylactic Trials With Assured New Treatment for Those at Greater Risk: I. a Design Proposal Finkelstein, Michael O.; Levin, Bruce; Robbins, Herbert (1996-05)OBJECTIVES: The accepted sine qua non for estimating the difference in efficacy between a new and a standard treatment is a randomized controlled clinical trial. Yet in some situations it is either practically or ...
When Ethics Constrains Clinical Research: Trial Design of Control Arms in "Greater Than Minimal Risk" Pediatric Trials de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G (2011-09)For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, ...