Boyer J G, Pathak D S
Glaxo Inc., Research Triangle Park, NC.
Top Hosp Pharm Manage. 1994 Jan;13(4):1-10.
Establishing the value of a new medicine by applying the tools and methods of pharmacoeconomics has become an important third objective in many clinical trials. The pharmacoeconomic investigator conducting research in clinical trials must understand and conform to the rules and procedures governing the clinical trial process. This article addresses some of the vital yet often overlooked details associated with conducting pharmacoeconomic research in clinical trials. The protocol, the informed consent form, the data collection instruments, the study initiation, and the final study report are all discussed. Additionally, limitations of the study results are reviewed.
通过应用药物经济学的工具和方法来确定一种新药的价值，已成为许多临床试验中的第三个重要目标。在临床试验中开展研究的药物经济学研究者必须理解并遵守临床试验过程的规则和程序。本文讨论了在临床试验中开展药物经济学研究相关的一些重要但常被忽视的细节。文中对试验方案、知情同意书、数据收集工具、研究启动以及最终研究报告都进行了讨论。此外，还对研究结果的局限性进行了回顾。
