PDF(Pubmed)
Abstract：
The past decade has seen the increasing influence and relevance of real-world data (RWD) and real-world evidence (RWE) in healthcare decision making. The value added by RWD/RWE has prompted the pharmaceutical industry to develop high performing systems and practices to harness the power of evidence generated at the global level. However, this worldwide transformation provides outstanding opportunities to support capability building within local affiliates and to impact key country-level stakeholders through resulting evidence. Therefore, we present an Evidence Blueprint Initiative, which links the global and local (\"glocal\") skills, and furthermore addresses the opportunities and gaps in evidence generation capabilities at the local level. Cross-functional experts were recruited at the local, regional, and global level to define best practices. A framework was developed to characterize the foundational expertise needed and to assess markets\' existing capabilities. Subsequently, targeted roadmaps were developed and implemented to build capabilities in specific areas within each affiliate. The impact from the Blueprint is encouraging, resulting in improved local evidence plans, established evidence teams, enhanced RWD use and strategic implementation of patient centric science in local affiliates. The success of the Blueprint resides in empowering affiliates to realise their local evidence generation ambitions and to match them to their local context. It strengthens and expands the ties between various parts of the organisation and the external environment while building fit-for-future evidence capabilities from local affiliates.
摘要：
在过去的十年中，现实世界数据（RWD）和现实世界证据（RWE）在医疗保健决策中的影响力和相关性日益增强。RWD/RWE的增值促使制药业开发高性能的系统和实践，以利用全球一级产生的证据的力量。然而,这种全球范围的转变为支持当地分支机构的能力建设提供了绝佳的机会，并通过由此产生的证据影响关键的国家一级的利益相关者。因此,我们提出了证据蓝图倡议，它链接了全局和本地(“glocal”)技能，并进一步解决地方一级证据生成能力方面的机会和差距。在当地招募了跨职能专家，区域,和全球层面来定义最佳实践。开发了一个框架来描述所需的基础专业知识并评估市场现有能力。随后，制定并实施了有针对性的路线图，以在每个分支机构的特定领域建立能力。蓝图的影响令人鼓舞，从而改善了当地的证据计划，建立证据小组,在当地分支机构中加强RWD的使用和以患者为中心的科学的战略实施。蓝图的成功在于授权分支机构实现其本地证据生成野心并将其与本地环境相匹配。它加强和扩大组织各部分与外部环境之间的联系，同时从当地分支机构建立适合未来的证据能力。
