Table 1.

Conventional application examples of real-world data/real-world evidence from the perspective of clinical development in Japan

Categories	Purpose of use
Development strategy	1. Selection of the target disease 2. Incidence and prevalence of disease 3. Natural course of the disease 4. Background incidence of interesting safety events 5. Pattern of disease treatment 6. Disease burden of patients and caregivers 7. Identifying unmet needs of current therapy
Clinical trial design	1. Identifying unmet needs of current therapy 2. Understanding of potential confounders 3. Supporting documentation for the clinical trial protocol 4. Feasibility study
Promotion of enrolment of study subjects	1. Recruitment of the study subjects to clinical trials
Application dossier	1. Historical control data [14, 96] 2. Supplementary materials
Drug price calculation	1. Cost and health data to support drug pricing decisions
Expansion of indications	1. Application based on public knowledge