Observational study examining the feasibility of generating real-world evidence for new drug applications from the clinical trials database

Observational study examining the feasibility of generating real-world evidence for new drug applications from the clinical trials database - REALISE study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053533

Enrollment

70000

Registered

2024-02-04

Start date

2023-10-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable solid tumors

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Data from patients enrolled in SCRUM-Japan, SCRUM-Japan related studies, ARCAD database studies, and Flatiron health RWD study who did not refuse secondary use of information

Exclusion criteria

Exclusion criteria: Data of patients who refused to consent to the study or who explicitly refused to participate based on the content of the study published for opt-out Data of other patients who were deemed ineligible for inclusion in the study by the investigator

Design outcomes

Primary

Measure	Time frame
comparisons of response rate, progression-free survival, and overall survival between the data bases comparisons of insurances of data reliability between the data bases	—

Countries

Japan

Contacts

Public ContactHideaki Bando

National Cancer Center Hospital East Division of Drug and Diagnostic Development Promotion

hbando@east.ncc.go.jp04-7133-1111

Outcome results