Real-World Data (RWD) refers to data collected outside of randomized controlled clinical trials from routine clinical practice or other healthcare sources. These include data from electronic health records (EHR), health insurance claims data, patient registries, wearables, and other real-world care settings. In contrast to traditional study data, RWD reflects the actual use of drugs and therapies under everyday conditions. <\/p>\n
Real-World Data can originate from a variety of sources. Electronic health records (EHR\/EMR) contain structured and unstructured clinical information from routine treatment \u2013 including diagnoses, laboratory findings, medications, and treatment courses. Health insurance and claims data provide information on drug prescriptions, hospitalizations, and outpatient treatments at a population level. <\/p>\n
Patient registries are structured databases that systematically collect information on patient populations with specific diseases or therapies. Additionally, data from wearables, mobile health applications (mHealth), and patient-reported outcome instruments are gaining increasing importance. Social media data and mortality registries complement the spectrum of available RWD sources. <\/p>\n
The analysis of Real-World Data generates Real-World Evidence (RWE) \u2013 clinical evidence on the benefits and risks of medical products derived from the evaluation of RWD. In recent years, the EMA and FDA have significantly expanded the use of RWE in regulatory decision-making processes. In the field of medical devices (EU-MDR 2017\/745), Post-Market Clinical Follow-up (PMCF) studies are a central method for RWD collection after market launch. <\/p>\n
For medicinal products, the EMA permits the use of RWE to support marketing authorization applications, post-approval commitments, and in the assessment of real-world therapeutic effects in rare diseases (Orphan Drugs). EU Regulation 536\/2014 and the EMA guidelines on non-interventional studies define the conditions under which RWD-based studies are recognized for regulatory purposes. <\/p>\n
The analysis of Real-World Data poses high methodological demands, as RWD, unlike study data, was not collected for scientific purposes. Key challenges include confounding, selection bias, missing data, and heterogeneity of data sources. Methods such as propensity score matching, instrumental variable analyses, and multivariable regression models are used to control for confounding. <\/p>\n
Data quality is a critical factor: RWD sources may contain incomplete, erroneous, or inconsistent entries. A structured data governance process, clear definitions of exposure and outcome variables, and a pre-registered study protocol (SAP) are minimum requirements for regulatory usable RWE. The EMA has established concrete quality standards for RWD studies with its “Guidance on registry-based studies” and the DARWIN EU network. <\/p>\n
A central challenge in using Real-World Data is the heterogeneity of data formats and structures. In the EU, the European Health Data Space (EHDS) project focuses on harmonized data standards to enable the cross-border use of health data for research purposes. International standards such as FHIR (Fast Healthcare Interoperability Resources) and OMOP (Observational Medical Outcomes Partnership) Common Data Model enable the harmonization of heterogeneous RWD sources. <\/p>\n
Data protection is a critical factor when using RWD. The GDPR (DS-GVO, EU 2016\/679) applies to the processing of personal health data and defines strict requirements for consent, pseudonymization, and purpose limitation. Data from patient registries must generally be anonymized or pseudonymized before analysis. Ethics committees review data access and planned use, even for purely secondary analytical studies without patient contact. <\/p>\n
For full-service CROs like mediconomics, working with Real-World Data opens up new business areas and expands the spectrum of supported study designs. Non-interventional studies (NIS), registry evaluations, database studies, and post-market surveillance studies are based entirely or partially on RWD. Regulatory support in study planning, protocol development, data collection, and evaluation is a growing area of expertise in the CRO industry. <\/p>\n
Health Technology Assessment (HTA) procedures under EU-HTA Regulation 2021\/2282 increasingly rely on RWE as complementary evidence alongside randomized studies. Sponsors aiming for an early benefit assessment by the G-BA or other national HTA authorities must consider robust RWD strategies already in their clinical development planning. <\/p>\n
What is the difference between Real-World Data and Real-World Evidence?<\/strong><\/p>\n Real-World Data (RWD) refers to raw data from routine clinical practice \u2013 i.e., unprocessed information from patient records, registries, or billing systems. Real-World Evidence (RWE) is the clinical evidence generated through the methodologically sound analysis of this data. In short: RWD is the input, RWE is the output. Only RWE derived from high-quality RWD using appropriate methods is usable for regulatory purposes. <\/p>\n Can RWE replace randomized clinical trials?<\/strong><\/p>\n In most cases, RWE cannot fully replace randomized controlled trials (RCTs), as randomization largely eliminates confounding. However, RWE is suitable as a supplement \u2013 for example, for assessing long-term safety profiles, rare diseases with small patient populations, or for generating hypotheses for RCTs. For certain indications and in conjunction with synthetic control arms, the FDA has already accepted RWE as a primary source of evidence. <\/p>\n Which regulatory guidelines apply to RWD studies in the EU?<\/strong><\/p>\n Key guidelines include the EMA Guidance on registry-based studies (EMA\/REG\/637479\/2020), EU Regulation 536\/2014 for non-interventional studies, and the DARWIN EU quality standards. For medical devices, EU-MDR 2017\/745 regulates PMCF requirements as the most important RWD source after market launch. For HTA purposes, EU-HTA Regulation 2021\/2282 is decisive.<\/p>\n Real-World Data (RWD) refers to data collected outside of randomized controlled clinical trials from routine clinical practice or other healthcare sources. These include data from electronic health records (EHR), health insurance claims data, patient registries, wearables, and other real-world care settings. In contrast to traditional study data, RWD reflects the actual use of drugs and […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6756","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6756","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6756\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6756"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6756"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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