Table 1.

RWE Framework case studies

Mundipharma asset and challenge	Research objectives	Outcomes of interest	Data	Proposed study designs
Oral antidiabetic medication • Lack of European data regarding real-world effectiveness and outcomes	Demonstrate product value to inform business strategy and decision-making for providers and payers	Treatment pathways/patterns Effectiveness Resource use	Secondary data analysis	Retrospective, cohort, non-interventional study using data from electronic health/medical records or national registries
Portable, non-opioid analgesic inhaler for moderate-to-severe trauma pain • Lack of evidence regarding outcomes and the impact on resource utilization in real-world settings	Demonstrate product value to inform business strategy, indication selection, and decision-making for providers and payers	Epidemiology Patient experience Resource use Costs	Primary data collection	Retrospective or prospective, cohort, non-interventional study using data from chart review/abstraction, survey or other prospective observational study
Asthma inhaler • Need to demonstrate real-world effectiveness while maintaining some control of patient selection	Demonstrate product value to inform clinical trial planning and decision-making for regulatory agencies, providers, and payers	Treatment pathways/patterns Adherence/switching Safety Effectiveness Resource use	Hybrid (primary data collection supplemented with secondary data analysis)	Pragmatic trial and retrospective, cohort, non-interventional study using data from electronic health/medical records