艾昆纬-解锁有效利用现实世界数据的关键（英）

IQVIA Real World Data AssetsNavigate a crucial, complex ecosystem to generate insightsFebruary 2024 editionTable of contentsReal World Data: navigate a crucial, complex ecosystem 1 to generate insightsRWD and its uses 2From Real World Data to Real World Evidence 2Focus on main RWD sources 2Profile of the main Real World Data sources 4Real World Data possible uses 7RWD in a nutshell 9Data type relevance by research question 10Real World Data challenges 11Addressing some of the FAIR principles 11 Data findability 11Data accessibility and interoperability 14Data interoperability and reusability 17Innovative data access and uses 19 Multi country studies 22 Enriched studies 23 Artificial Intelligence and machine learning 25Glossary 28 iqvia.com | 1 Maximizing the potential of Real World Data for insights and evidence generationTraditional Randomized Clinical Trials (RCTs) are widely recognized as a reliable framework for generating evidence on the effectiveness and safety of health technologies for regulatory purposes. However, when alternative sources of evidence, such as Real World Data (RWD) from diverse settings are the only option, the rigid processes of RCTs pose a challenge. Consequently, health authorities and national health systems worldwide are increasingly accepting the need to move beyond relying solely on RCT data.… ALONG WITH CHANGES IN HOW IT IS CREATEDIn the rapidly growing Big Data universe, unprecedented amounts of person-level information contained in Electronic Health Record (EHR) systems contributes to the fastest compound annual growth rate of 36% forecasted till 2025 (growth of volume of health related data).1 The data originates from primary, specialist and hospital care, drug and disease registries, medical devices, digital apps, and other sources of health data which are generated every day. VOLUME IS GROWING IN ABSOLUTE TERMS …36%30%26%25%27%Healthcare2018–2025 data – compound annual growth rate (CAGR)Source: 1 Coughlin et al Internal Medicine Journal article “Looking to tomorrow’s healthcare today: a participatory health perspective”. IDC White Paper,Doc# US44413318, November 2018: The Digitization of the World – From Edge to Core”.ManufacturingFinancialserviceMedia andentertainmentGlobaldatasphereThey include structured data in the form of diagnoses, medication, laboratory test results, etc. with different levels of granularity. They also include unstructured data in clinical narratives, for example all of which likely contain invaluable insights for most research projects along the development lifecycle, some of them becoming essential for regulatory purposes. These datasets are often siloed by country, language, region, hospital and even department. Real World data also originate from a multitude of disease specific contexts and so vary greatly in complexity. As a consequence of this great diversity, it is broadly acknowledged that state-of-the-art tools are needed to make such healthcare data Findable, Acces