Maeda Kazuki, Katashima Rumi, Ishizawa Keisuke, Yanagawa Hiroaki
Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.
Institutional Review Board, Tokushima University Hospital, Tokushima, Japan.
J Clin Med Res. 2015 Dec;7(12):956-60. doi: 10.14740/jocmr2328w. Epub 2015 Oct 23.
Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians' views on PMS with the aim of conducting PMS more effectively.
We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians' attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts.
Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies.
Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure.
药物注册试验对于药物获批至关重要。获批后，需持续努力以确保获批药物的合理使用。在日本，制药公司的上市后监测（PMS）是按照良好的上市后研究规范（GPSP）进行的。尽管全球药物警戒标准已纳入GPSP，但最近人们的注意力集中在将它们区分开来。在本研究中，我们调查了医生对PMS的看法，旨在更有效地开展PMS。
我们回顾性地查阅了日本农村地区的学术医院德岛大学医院机构审查委员会2009年至2013年的记录。然后确定每年进行PMS的次数。接下来，我们在一项横断面研究中，使用为本研究设计的问卷评估医生对药物PMS的态度，包括伦理问题。使用了五分制和两分制量表。问卷于2014年分发给列为PMS合同研究者的221名医生。
221名医生中，103名（46.6%）回复了问卷。约50%的受访者有撰写PMS报告的经验。许多医生认为PMS很重要但负担很重。此外，从研究伦理的角度来看，许多医生认为在目前的PMS框架内，在额外采血、提供图像、监测和对照研究的情况下，未经知情同意收集和提供超出常规临床实践范围的数据是不合适的。
除了工作量等实际因素外，还应关注建立日本PMS系统的伦理基础设施和全球统一系统。鉴于这项单机构研究的局限性，需要进一步研究以收集信息来建立合适的基础设施。
