Mauskopf J, Schulman K, Bell L, Glick H
Glaxo Wellcome Inc., Research Triangle Park, North Carolina, USA.
Pharmacoeconomics. 1996 Mar;9(3):264-77. doi: 10.2165/00019053-199609030-00007.
This article presents an overview of the process and organisational aspects required to support the collection of pharmacoeconomic (PE) data during phase II and phase III clinical trials of pharmaceutical products. The process described requires early involvement of the PE study team in clinical trials design and planning, as well as continuing close collaboration between the PE study team and the clinical study team as the data collection plans are implemented. Adequate resources must be made available for staffing and funding the PE component of data collection and analysis. If the suggested procedures are adequately resourced and implemented, the result should be a comprehensive, complete and accurate database that will allow the PE study team to characterise the economic value of the new drug at the same time as the clinical study team characterise its safety and efficacy. Integrated clinical and economic evaluations are essential for the appropriate use of pharmaceutical products in rapidly changing markets.
本文概述了在药品的II期和III期临床试验期间支持药物经济学（PE）数据收集所需的流程和组织方面。所描述的流程要求PE研究团队在临床试验设计和规划中尽早介入，并且在实施数据收集计划时，PE研究团队与临床研究团队持续密切合作。必须提供充足的资源，用于配备人员以及为数据收集和分析的PE部分提供资金。如果所建议的程序有足够的资源并得以实施，结果应该是一个全面、完整且准确的数据库，这将使PE研究团队能够在临床研究团队描述新药的安全性和有效性的同时，描述其经济价值。在快速变化的市场中，综合临床和经济评估对于合理使用药品至关重要。
