USE OF REAL-WORLD EVIDENCE ON US BRANDED HCP DRUG WEBSITES: AN AI-ENABLED CONTENT ANALYSIS
Author(s)
Keller J. Balsam, BSc1, Justin Yu, PharmD, M.S.2, Yamini Misra, BSc, MBA3, Rachel M. Black, PharmD, MPS4;
1AESARA, Durham, NC, USA, 2AESARA, Chapel Hill, NC, USA, 3AESARA, Houston, TX, USA, 4AESARA, Austin, TX, USA
1AESARA, Durham, NC, USA, 2AESARA, Chapel Hill, NC, USA, 3AESARA, Houston, TX, USA, 4AESARA, Austin, TX, USA
OBJECTIVES: To characterize how pharmaceutical companies present product-specific real-world evidence (RWE) on US healthcare professional (HCP) product websites, including evidence types, intended use cases, and transparency practices.
METHODS: We compiled a broad list of branded drugs marketed in the United States using data from FDA.gov, RxAssist.org, and Drugs.com. An AI-enabled workflow was applied to identify product-specific RWE on publicly accessible HCP product webpages. Identified webpages were subsequently reviewed by a human analyst to confirm findings and extract additional details, including data source, evidence type, and comparator context.
RESULTS: Across 643 unique branded HCP websites, 105 (16%) included product-specific RWE. The most common explicitly stated data types were electronic health records (13%), administrative claims (9%), survey data (3%), multiple data sources (3%), and registry data (1%). However, 58% of websites did not provide sufficient information to identify the underlying data source, and only 35% disclosed the names of data sources used to generate RWE.
In terms of clinical context, 58% of websites linked RWE to efficacy claims only, 17% to safety claims only, and 20% to both efficacy and safety claims. The remaining websites included RWE related to healthcare resource utilization and/or costs (5%). 11% of websites included head-to-head comparisons against one or more specified comparators.
CONCLUSIONS: Product-specific RWE on US branded HCP product websites is most frequently used to support efficacy-related claims, with less frequent application to safety, economic outcomes, or head-to-head comparisons. Substantial variation in the disclosure of data types, data sources, and comparator context suggests inconsistency in how RWE is communicated to clinical audiences. These findings highlight the potential value of more structured frameworks or guidance to support transparent, consistent, and credible communication of RWE in promotional HCP focused settings.
METHODS: We compiled a broad list of branded drugs marketed in the United States using data from FDA.gov, RxAssist.org, and Drugs.com. An AI-enabled workflow was applied to identify product-specific RWE on publicly accessible HCP product webpages. Identified webpages were subsequently reviewed by a human analyst to confirm findings and extract additional details, including data source, evidence type, and comparator context.
RESULTS: Across 643 unique branded HCP websites, 105 (16%) included product-specific RWE. The most common explicitly stated data types were electronic health records (13%), administrative claims (9%), survey data (3%), multiple data sources (3%), and registry data (1%). However, 58% of websites did not provide sufficient information to identify the underlying data source, and only 35% disclosed the names of data sources used to generate RWE.
In terms of clinical context, 58% of websites linked RWE to efficacy claims only, 17% to safety claims only, and 20% to both efficacy and safety claims. The remaining websites included RWE related to healthcare resource utilization and/or costs (5%). 11% of websites included head-to-head comparisons against one or more specified comparators.
CONCLUSIONS: Product-specific RWE on US branded HCP product websites is most frequently used to support efficacy-related claims, with less frequent application to safety, economic outcomes, or head-to-head comparisons. Substantial variation in the disclosure of data types, data sources, and comparator context suggests inconsistency in how RWE is communicated to clinical audiences. These findings highlight the potential value of more structured frameworks or guidance to support transparent, consistent, and credible communication of RWE in promotional HCP focused settings.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PT39
Topic
Real World Data & Information Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas