Levin Leslie
MaRS EXCITEandUniversity of
Int J Technol Assess Health Care. 2015 Jan;31(4):207-9. doi: 10.1017/S0266462315000422. Epub 2015 Nov 11.
With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.
随着人们越来越意识到政策制定者、卫生技术评估机构、监管机构和支付方与行业在上市前阶段需要积极互动，一种颠覆性的综合方法被提出，该方法将证据收集过程完全转移到这一阶段。为满足监管和覆盖需求及期望而在上市前进行的单一协调研究更有可能高效且成本更低，并为推动而非检验创新提供证据支持。文中简要讨论了加拿大安大略省通过MaRS EXCITE项目正在进行概念验证的此类过程的一个例子。还提供了决策者与行业在上市前进行对话的其他例子，不过这些例子不如全面的证据收集方法有力。
