Medina Jesús, Sánchez-Covisa Joaquín, Nuevo Javier, Palacios Beatriz, Roncero Ana, Alegría Marta, Gostkorzewicz Joana, Velasco Antonio, Larsen Kristoffer, Moreno Marta, Velasco César, Pérez Domínguez Ana
Biopharmaceuticals Medical, AstraZeneca Farmacéutica Spain, Medical Affairs Department, C. del Puerto de Somport 21-23, Fuencarral-El Pardo, 28050, Madrid, Spain.
AstraZeneca Spain, Corporate Affairs and Market Access Department, Madrid, Spain.
Pharmaceut Med. 2025 Jul 21. doi: 10.1007/s40290-025-00575-w.
The role of Medical Affairs (MA) has shifted from traditional evidence dissemination to an integrated process leveraging real-world data (RWD) and diverse data sources. To adapt and lead this shift, AstraZeneca (AZ) Spain recognized the essential need to identify gaps in evidence-generation capabilities and establish targeted strategies aligned with both global and local priorities. The objective of this work was to assess AZ Spain's current evidence-generation capabilities and identify areas for improvement by using the so-called "Evidence Blueprint" framework. To do this, we conducted a systematic self-assessment following the Blueprint to evaluate performance across ten core areas. An approach to identify gaps and enhance evidence-generation processes was undertaken in four phases: defining capabilities, assessing maturity, developing a roadmap for improvement, and implementing changes. The self-assessment identified five priority areas, including two focused priorities-Innovative Value Strategies/Payer Evidence and RWD Vision and Strategy-as well as three improvement areas-Evidence Planning and Value Team Implementation, Research/Evidence Partnerships, and Patient-Centric Evidence. Tangible actions included the development of processes to assess outcome-based agreements, comprehensive mapping of existing national and regional databases to strengthen RWD strategies, creating a cross-functional strategy for evidence planning, establishing research partnerships leveraging European funding, and adopting patient-centric methodologies such as ethnographic studies and patient-authored publications. The initiatives undertaken by AZ Spain demonstrate the transformative potential of an Evidence Blueprint framework in addressing gaps and enhancing evidence-generation capabilities. By aligning local strategies with AZ's MA 2030 vision, these efforts ensure continuous innovation, improvement of decision-making, and a more substantial contribution to the healthcare ecosystem.
医学事务(MA)的角色已从传统的证据传播转变为利用真实世界数据(RWD)和多种数据源的综合流程。为了适应并引领这一转变,阿斯利康(AZ)西班牙公司认识到,必须找出证据生成能力方面的差距,并制定与全球和本地优先事项相一致的针对性战略。这项工作的目标是通过使用所谓的“证据蓝图”框架,评估AZ西班牙公司当前的证据生成能力,并确定改进领域。为此,我们按照该蓝图进行了系统的自我评估,以评估十个核心领域的表现。我们分四个阶段采取了一种找出差距并加强证据生成流程的方法:定义能力、评估成熟度、制定改进路线图以及实施变革。自我评估确定了五个优先领域,包括两个重点优先事项——创新价值战略/支付方证据以及真实世界数据愿景与战略,以及三个改进领域——证据规划与价值团队实施、研究/证据伙伴关系以及以患者为中心的证据。具体行动包括制定评估基于结果协议的流程、全面梳理现有的国家和地区数据库以加强真实世界数据战略、制定证据规划的跨职能战略、利用欧洲资金建立研究伙伴关系,以及采用以患者为中心的方法,如实情记录研究和患者撰写的出版物。AZ西班牙公司开展的这些举措展示了证据蓝图框架在解决差距和增强证据生成能力方面的变革潜力。通过使本地战略与AZ的医学事务2030愿景保持一致,这些努力确保了持续创新、决策改进以及对医疗生态系统做出更大贡献。