Crowe Daniel
Southboro Medical Group, 24 Newton Street, Southborough, MA 01772, USA.
J Diabetes Sci Technol. 2009 Jan;3(1):154-5. doi: 10.1177/193229680900300117.
Multiple industry-sponsored studies have been published about the accuracy of insulin delivery using prefilled insulin pens. Although the study by Weise and colleagues in this issue of Journal of Diabetes Science and Technology found that the Novo Nordisk device was slightly more accurate than the Sanofi-Aventis device, one can anticipate a Sanofi-Aventis-funded study that may find the opposite, because no internationally acceptable, publicly funded, unbiased scientific organization exists to perform head-to-head comparisons of drugs and devices in an evidence-based manner. Currently, clinicians are left on their own to determine whether a study on this topic was conducted in an accurate, unbiased manner. A fundamental redesign of clinical research could reinvigorate and revolutionize the process by which innovations travel from the bench to the bedside. As we anticipate changes in healthcare in the future, it is imperative that the approval and postmarketing surveillance process is revised to support the practice of true evidence-based medicine.
已经发表了多项由行业赞助的关于使用预填充胰岛素笔进行胰岛素给药准确性的研究。尽管魏斯及其同事在本期《糖尿病科学与技术杂志》上的研究发现,诺和诺德公司的设备比赛诺菲-安万特公司的设备略精确,但可以预期赛诺菲-安万特公司资助的一项研究可能会得出相反的结论,因为不存在一个国际上可接受的、由公共资金支持的、无偏见的科学组织以循证的方式对药物和设备进行直接比较。目前,临床医生只能自行判断关于这个主题的研究是否是以准确、无偏见的方式进行的。临床研究的根本性重新设计可以重振并彻底改变创新从实验室走向临床的过程。随着我们预期未来医疗保健的变化,必须修订批准和上市后监测程序,以支持真正的循证医学实践。