LEVERAGING REAL-WORLD DATA IN PHARMACEUTICAL INFORMATION TECHNOLOGY: ADVANCING DRUG DEVELOPMENT AND PATIENT CARE
Keywords:
Real-World Data (RWD), Healthcare Analytics, Clinical Decision Support, Regulatory Compliance, Drug DevelopmentAbstract
Integrating Real-World Data (RWD) with pharmaceutical information technology has fundamentally transformed healthcare delivery and drug development processes. This comprehensive article examines how RWD from electronic health records, insurance claims, and patient registries has revolutionized clinical decision-making, regulatory compliance, and patient care outcomes. Implementing RWD has enabled more efficient clinical trial design, enhanced post-market surveillance, and improved therapeutic effectiveness assessment. Healthcare providers have benefited from advanced clinical decision support systems and quality improvement initiatives, while regulatory bodies have strengthened their decision-making processes through enhanced data analysis capabilities. Despite technical challenges in data integration and analytics infrastructure, organizations have developed robust solutions for managing complex healthcare data systems, significantly improving patient care delivery and pharmaceutical research outcomes.
References
Mario Miozza et al., "Digital transformation of the Pharmaceutical Industry: A future research agenda for management studies," Technological Forecasting and Social Change, Volume 207, October 2024, 123580. [Online]. Available: https://www.sciencedirect.com/science/article/pii/S0040162524003767
Woojung Lee et al., "Use of real-world evidence in economic assessments of pharmaceuticals in the United States," J Manag Care Spec Pharm. 2021 Jan. [Online]. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC10390921/
Dr. Tom Joseph Seymour et al., "Electronic Health Records (EHR)," ResearchGate, October 2014. [Online]. Available: https://www.researchgate.net/publication/267226700_Electronic_Health_Records_EHR
Tamar Klaiman et al., "Leveraging Effective Clinical Registries to Advance Medical Care Quality and Transparency," Population Health Management, 4 April 2014. [Online]. Available: https://www.liebertpub.com/doi/10.1089/pop.2013.0021
Michael J. Eckrote et al., "Linking clinical trial participants to their U.S. real-world data through tokenization: A practical guide," Contemporary Clinical Trials Communications, Volume 41, October 2024, 101354. [Online]. Available: https://www.sciencedirect.com/science/article/pii/S2451865424001017
Theodoros G Soldatos et al., "Advancing drug safety science by integrating molecular knowledge with post‐marketing adverse event reports," CPT Pharmacometrics Syst Pharmacol. 2022 Feb 20. [Online]. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC9124355/
Santhosh Kumar Pendyala, "Real-time Analytics and Clinical Decision Support Systems: Transforming Emergency Care," ResearchGate, 2024. [Online]. Available: https://www.researchgate.net/publication/386104558_Real-time_Analytics_and_Clinical_Decision_Support_Systems_Transforming_Emergency_Care
Georg Melzer et al., "Leveraging Real-World Data for the Selection of Relevant Eligibility Criteria for the Implementation of Electronic Recruitment Support in Clinical Trials," Appl Clin Inform. 2021 Jan 13;12(1):17–26. [Online]. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC7806423/
Alison Cave et al., "Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe," Clin Pharmacol Ther. 2019 Apr 10;106(1):36–39. [Online]. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC6617710/#:~:text=Conclusions,across%20the%20product%20life%20cycle
CIOMS Working Group report, "Real-world data and real-world evidence in regulatory decision making," 6 June 2023. [Online]. Available: https://cioms.ch/wp-content/uploads/2020/03/CIOMS-WG-XIII_6June2023_Draft-report-for-comment.pdf
Konstantinos Zisis et al., "Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process," J Pharm Pharm Sci. 2024 Feb 28;27:12302. [Online]. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC10932954/
McKinsey & Company, "Real-world data quality: What are the opportunities and challenges?" January 5, 2023. [Online]. Available: https://www.mckinsey.com/industries/life-sciences/our-insights/real-world-data-quality-what-are-the-opportunities-and-challenges
