Shaping the Future of Evidence Generation: Real-World Data to Drive Healthcare Transformation and Patient-Centered Decisions.

The increasing complexity of healthcare decision making and the demand for real-world evidence call for a transformation in how Medical Affairs departments generate and communicate evidence. In response, AstraZeneca Spain implemented a structured stakeholder-driven framework aligned with the Clinical Evidence 2030 and Medical Affairs 2030 visions, aiming to deliver high-impact, timely, and tailored insights across each therapeutic area. An ambitious evidence generation vision was developed around two core components: (1) enhanced therapeutic area knowledge leading to improvements in guideline-directed medical therapy for patients and (2) strategic use of evidence for the company, leading to improved efficiency in delivering healthcare innovation for patients. The first component encompasses a broad spectrum of study modalities, such as the generation of real-world data on the use of medicines, health economics and outcomes research, predictive analytics, clinical management, and patient experience studies using diverse data sources, including real-world databases, registries, and electronic health records. Studies address different research questions and data gaps, including disease burden, treatment patterns, economic modeling, patient experience through ethnographic research, and knowledge derived from artificial intelligence-driven analytics. The second component seeks to ensure that the evidence generated is used strategically. First, it should be the basis for the development of a powerful Value Story that conveys the clinical, economic, and humanistic value of a pharmaceutical product and creates confidence in regulators, payers, and prescribers, thereby strengthening its therapeutic positioning. Second, the evidence generated needs to be presented to stakeholders in a dynamic manner, enhancing decision-making processes and fostering real-time engagement with healthcare providers and payers. Here, we present a data visualization tool that was developed to this end, termed ATLAS. Third, results from real-world evidence studies can be used to inform outcome-based agreements with payers. This type of innovative value strategy that goes beyond traditional financial agreements represents a method to ensure that the clinical and economic value delivered by a product is reflected in healthcare pricing and reimbursement models, facilitating broader access and timely patient care. AstraZeneca Spain's evidence generation approach represents a significant contribution to the evolution of Medical Affairs into a strategic driver of healthcare innovation and, ultimately, patient benefit. It implies an effort in the consolidation of unique features such as the increase in robust methodological capabilities and versatility in the design of studies, the leverage of predictive analytics, the development of advanced data visualization tools, the emphasis on patient-centered research, and the collaboration with partners expert in emerging technologies. The ultimate goals of an ambitious evidence generation vision like this are to provide the data needed for decision making at all levels, to identify opportunities to enhance diagnosis, to accelerate access to innovative therapies, and to ensure more patients receive optimal care.