Lose Gunnar
Department of Obstetrics and Gynecology, Glostrup Municipal Hospital, Ndr. Ringvej, 2600, Glostrup, Denmark.
Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jun;18(6):599-601. doi: 10.1007/s00192-007-0318-8. Epub 2007 Mar 24.
The massive introduction of new products from device and drug industries together with a scanty device approval process and a growing scepticism about the reliability of drug trials call for new improved strategies in urogynaecological research. Device companies and physicians have a mutual ethical responsibility of contributing to create clinical data based on the framework of trials in surgery before new surgical products are implemented and disseminated. In respect of the patients' altruism and confidence, which make drug trials possible, the industry and academia have an obligation to conduct and report clinical results in accordance with the highest standards of scientific and ethical integrity.
设备和制药行业大量推出新产品,加上设备审批程序不完善以及对药物试验可靠性的怀疑日益增加,这就需要在泌尿妇科研究中采用新的改进策略。在新的手术产品实施和推广之前,设备公司和医生有共同的道德责任,在手术试验框架的基础上为创建临床数据做出贡献。考虑到患者的利他主义和信任使得药物试验成为可能,行业和学术界有义务按照科学和道德诚信的最高标准开展和报告临床结果。