University of York and Health Technology Assessment International.
Int J Technol Assess Health Care. 2011 Jul;27(3):253-60. doi: 10.1017/S0266462311000262.
The relationship between regulatory approval on the one hand and health technology assessment (HTA) and coverage on the other is receiving growing attention. Those responsible for regulatory approval, HTA, and coverage have different missions and their information requirements reflect these. There is nonetheless an increasingly popular view that improved communication and coordination between these functions could allow them all to be undertaken effectively with a lower overall burden of evidence requirements, thus speeding patient access to new products and reducing unnecessary barriers to innovation. This study summarizes the main points emerging from a recent discussion of this topic at the HTAi Policy Forum.
After considering the roles of the various bodies, stakeholder perspectives and some current practical initiatives, those present at the Forum meeting discussed possible goals and challenges for improved interactions-in general and at specific stages of the product development life cycle. Opportunities for progress were seen in: continuing the dialogue to promote understanding and interaction between the different bodies and stakeholders; working to align scientific advice for manufacturers on the design and data requirements of pre- and post-marketing evaluation of products (specifically phase 2/3 and phase 4 trials for drugs); and extending the current dialogue to include discussion of product development to address unmet health needs.
监管审批与卫生技术评估（HTA）和覆盖范围之间的关系正受到越来越多的关注。负责监管审批、HTA 和覆盖范围的人员有不同的任务，他们的信息需求反映了这一点。然而，人们越来越普遍认为，改善这些职能之间的沟通和协调，可以在降低整体证据要求负担的情况下，更有效地开展这些职能，从而加快患者获得新产品的速度，并减少创新的不必要障碍。本研究总结了 HTAi 政策论坛最近一次讨论这一主题时出现的主要观点。
在考虑了各机构的角色、利益相关者的观点和一些当前的实际举措之后，论坛会议上的与会者讨论了在产品开发生命周期的各个阶段改进互动的可能目标和挑战。有机会取得进展的方面包括：继续对话，促进不同机构和利益相关者之间的理解和互动；努力使制造商就产品上市前和上市后评估（特别是药物的 2/3 期和 4 期试验）的设计和数据要求的科学建议保持一致；将当前的对话扩展到包括讨论产品开发，以解决未满足的健康需求。
