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Unformatted text preview: Lecture 3/05/09 Knowledge Production and Clinical Trials Stephen Hilgartner Goals of Clinical Trials? • Establish safety and efficacy of drugs o Efficacious new drugs o Safety of patients o Safety of human subjects • Production of Scientific knowledge • Product Development and marketing • Scientific and business careers • POTENTIALLY CONFLICTING! FDA Regulatory Apparatus • Phase I – dozens of Pts, safety • Phase II – few hundred Pts • Phase III – large number of Pts • Division of Pts into groups: different treatments • Safety, effectiveness, side effects • Statistical analysis • Company submits data, FDA reviews Criticism From Many Directions • “Overregulation” – delay • “Captured by industry” • “Industry focused on marketing” • Problems: e.g., Vioxx o Best-selling drug, heart attacks, pulled in 2004 o Merck agrees to pay $4.85 billion, tens of thousands of lawsuits Expansions of Clinical Trials • Before WWII: HE (Human experimentation) was relatively small scale • Now: HE is a massive enterprise • Increasingly global in scope Regulation of Human Subject Research • Classic role conflict: o Doctor as clinician o Doctor as researcher o Individual context? • Role conflicts in complex institutional context? 4 Policy Frames • Policy frames – these structure understanding the problems policies are intended to address, the solutions, the goals and focus of policy •...
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- Fall '09