Table 2.

Uses of RWE to provide insights needed for clinical development

Theme	Understanding patient population	Understanding health care utilization	Understanding disease
Components	Prevalence Incidence Population size Comorbidities Temporal trends Diagnostic journey	Quantity/quality of health care Standard of care Unmet needs Clinical trial sites Adherence/persistence	Natural history Disease progression Disease segmentation Endpoints Sample size
Potential uses	Viability of: ○Clinical development regulatory pathway ○Commercialization	Developing value proposition Benchmarking against competitors Identifying health care disparities	Trial feasibility Trial modeling Trial design Generating hypotheses Effect size

RWE, real‐world evidence.