lecture 3-05-09 - Lecture Knowledge Production and Clinical...

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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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