So D, Joly Y, Knoppers B M
Centre for Genomics and Policy, McGill University, Montreal, Que., Canada.
Public Health Genomics. 2013;16(6):322-35. doi: 10.1159/000355941. Epub 2014 Feb 3.
Data sharing from clinical trials can be key to the development and approval of medicines for rare diseases. Many events during the first half of 2013 have contributed to the movement for increased transparency. These include the development of the European Medicines Agency's new data publication policy, the creation of the AllTrials petition and GlaxoSmithKline's choice to sign it, the launch of GlaxoSmithKline's system for access to patient-level clinical trial data and Roche's commitment to create a similar system, the release of results from the Yale University Open Data Access project's first medicine analysis for Medtronic, and the creation of the Reg4All website.
AIMS/OBJECTIVES: This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline.
GlaxoSmithKline's database of available trials was tabulated and graphs of relevant trial characteristics were produced.
RESULTS/CONCLUSIONS: Due to current transparency initiatives, it is likely that much more data will be made available over the next few years through systems similar to GlaxoSmithKline's. Although some aspects of GlaxoSmithKline's model could limit its usefulness, the data currently listed is diverse and could be promising for researchers interested in rare disease treatment.
临床试验数据共享对于罕见病药物的研发与获批可能至关重要。2013年上半年发生的诸多事件推动了提高透明度的行动。这些事件包括欧洲药品管理局新数据发布政策的制定、“全试验”请愿活动的发起以及葛兰素史克选择签署该请愿书、葛兰素史克患者层面临床试验数据获取系统的推出以及罗氏公司创建类似系统的承诺、耶鲁大学开放数据访问项目对美敦力公司首款药物分析结果的发布以及Reg4All网站的创建。
本文总结了2013年1月至6月期间临床试验透明度方面的主要进展，并分析了葛兰素史克发布的数据集构成。
将葛兰素史克现有试验数据库制成表格，并绘制相关试验特征的图表。
结果/结论：由于当前的透明度倡议，未来几年很可能会通过类似于葛兰素史克的系统提供更多数据。尽管葛兰素史克模式的某些方面可能会限制其效用，但目前列出的数据种类多样，对于关注罕见病治疗的研究人员而言可能很有前景。
