Raymond J, White P, Kallmes D F, Spears J, Marotta T, Roy D, Guilbert F, Weill A, Nguyen T, Molyneux A J, Cloft H, Cekirge S, Saatci I, Bracard S, Meder J F, Moret J, Cognard C, Qureshi A I, Turk A S, Berenstein A
Interventional Neuroradiology Research Unit, Department of Radiology, Université de Montreal, CHUM Notre-Dame Hospital, Montréal, Canada -
Interv Neuroradiol. 2008 Jun 30;14(2):203-8. doi: 10.1177/159101990801400213.
The proliferation of new endovascular devices and therapeutic strategies calls for a prudentand rational evaluation of their clinical benefit. This evaluation must be done in an effective manner and in collaboration with industry. Such research initiative requires organisation a land methodological support to survive and thrive in a competitive environment. We propose the formation of an international consortium, an academic alliance committed to the pursuit of effective neurovascular therapies. Such a consortium would be dedicated to the designand execution of basic science, device developmentand clinical trials. The Consortium is owned and operated by its members. Members are international leaders in neurointerventional research and clinical practice. The Consortium brings competency, knowledge, and expertise to industry as well as to its membership across aspectrum of research initiatives such as: expedited review of clinical trials, protocol development, surveys and systematic reviews; laboratory expertise and support for research design and grant applications to public agencies. Once objectives and protocols are approved, the Consortium provides a stable network of centers capable of timely realization of clinical trials or pre clinical investigations in an optimal environment. The Consortium is a non-profit organization. The potential revenue generated from clientsponsored financial agreements will be redirected to the academic and research objectives of the organization. The Consortium wishes to work inconcert with industry, to support emerging trends in neurovascular therapeutic development. The Consortium is a realistic endeavour optimally structured to promote excellence through scientific appraisal of our treatments, and to accelerate technical progress while maximizing patients' safety and welfare.
新型血管内装置和治疗策略的不断涌现,要求对其临床益处进行审慎且合理的评估。这种评估必须以有效的方式进行,并与行业合作开展。此类研究计划需要组织架构和方法学支持,才能在竞争环境中生存和发展。我们提议组建一个国际联盟,这是一个致力于寻求有效神经血管治疗方法的学术联盟。这样一个联盟将专注于基础科学的设计与实施、装置研发以及临床试验。该联盟由其成员所有并运营。成员均为神经介入研究和临床实践领域的国际领军人物。联盟为行业及其成员带来能力、知识和专业技能,涵盖一系列研究计划,例如:加快临床试验审查、制定方案、开展调查和系统评价;提供实验室专业知识以及对研究设计的支持,并协助向公共机构申请资助。一旦目标和方案获得批准,联盟将提供一个稳定的中心网络,能够在最佳环境中及时开展临床试验或临床前研究。该联盟是一个非营利组织。客户赞助的财务协议所产生的潜在收入将重新用于该组织的学术和研究目标。联盟希望与行业协同合作,支持神经血管治疗发展的新趋势。该联盟是一项切实可行的举措,其结构经过优化,旨在通过对我们的治疗方法进行科学评估来推动卓越发展,并在最大限度保障患者安全和福祉的同时加速技术进步。