Clinical Research Facilitators, LLC, 1138 Lake Point Way, Suwanee, GA 30024-8485, USA.
Urol Oncol. 2012 Jul-Aug;30(4 Suppl):S33-9. doi: 10.1016/j.urolonc.2012.01.008.
The impact of innovation and the effectiveness of research on healthcare is nothing short of remarkable; one need only to reflect on the breakthroughs of the past quarter century to understand the accomplishments of physician investigators and the benefits their research have bestowed upon society. Yet the success of any clinical trial relies heavily on the ability of the investigator to understand his/her role in compliant trial conduct, to evaluate the merits of an investigational product, the protocol design, willingness of subjects to participate in clinical trials, and the ability of his/her site to meet sponsor expectations. This article provides basic insight into the challenges and opportunities offered by clinical trial participation, while assisting new and experienced investigators in selecting an appropriate research model for their practice.
创新和研究对医疗保健的影响是非常显著的;人们只需要回顾过去四分之一个世纪的突破,就可以了解医师研究人员的成就以及他们的研究为社会带来的益处。然而,任何临床试验的成功都在很大程度上依赖于研究人员理解其在合规试验中的作用、评估研究产品的优点、方案设计、受试者参与临床试验的意愿以及其研究场所满足赞助商期望的能力。本文提供了对临床试验参与所带来的挑战和机遇的基本了解,同时帮助新的和有经验的研究人员为其实践选择合适的研究模式。