Regulatory Benefit-Risk Assessment and Comparative Effectiveness ResearchStrangers, Bedfellows or Strange Bedfellows?

被引:0
作者
Louis P. Garrison
机构
[1] University of Washington,Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy
来源
PharmacoEconomics | 2010年 / 28卷
关键词
Rosiglitazone; Glyburide; Comparative Effectiveness Research; Level Playing Field; Diabetes Drug;
D O I
暂无
中图分类号
学科分类号
摘要
Over the past 5 years, we have witnessed growing interest in both comparative effectiveness research (CER) and regulatory benefit-risk assessment (BRA). Both deal with benefits and harms, although at different stages of the product lifecycle. There are growing pressures for a more systematic and quantitative approach to regulatory BRA. However, there is also a need for CER–beyond the evidence that can reasonably be generated during prelaunch product development.
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页码:855 / 865
页数:10
相关论文
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  • [1] Arrow KJ(1963)Uncertainty and the welfare economics of medical care Amer Econ Rev 53 941-73
  • [2] Garrison LP(2010)Rewarding value creation to promote innovation in oncology: the importance of considering the global product life cycle Oncologist 15 49-57
  • [3] Nissen SE(2004)US Food and Drug Administration Draft guidances for industry on premarketing risk assessment; development and use of risk minimization action plans; and good pharmacovigilance practices and pharmacoepidemiologic assessment [docket nos. 2004D-0187, 2004D-0188 and 2004D-0189] 69 25130-2
  • [4] Wolski K(2007)Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes [published erratum appears in N Engl J Med 2007; 357 (1): 100] N Engl J Medz 356 2457-71
  • [5] Johnson FR(2009)Using conjoint analysis to estimate healthy-year equivalents for acute conditions: an application to vasomotor symptoms Value Healt 12 146-52
  • [6] Hauber AB(2007)Assessing a structured, quantitative health outcomes approach to drug riskbenefit analysis Health Aff 26 684-95
  • [7] Oözdemir S(2002)A comparison of the effects of rosiglitazone and glyburide on cardiovascular function and glycemic contol in patients with type 2 diabetes Diabetes Care 25 2058-64
  • [8] Garrison LP(2002)A Diabetes Outcome Progression Trial (ADOPT): an international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes Diabetes Care 25 1737-43
  • [9] Towse A(2008)Glucose control and vascular complications in veterans with type 2 diabetes N Engl J Med 360 129-39
  • [10] Bresnahan BW(2009)Comparative effectiveness research for antipsychotic medications: how much is enough Health Aff 28 794-808