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Characteristics of pre- and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration

Characteristics of pre- and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration: A meta-epidemiological investigation - Accelerated approval of non-cancer drugs by the US FDA

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000039281
Enrollment
73
Registered
2020-02-29
Start date
2020-01-27
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

All the drug indications other than cancer treatment that received accelerated approval by the FDA

Interventions

None listed

Sponsors

Department of Health Promotion and Human Behavior, Kyoto University School of Public Health in the Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All the drug indications that received accelerated approval by the FDA since 1992

Exclusion criteria

Exclusion criteria: The indications approved for cancer treatment

Design outcomes

Primary

MeasureTime frame
Completion of post-approval confirmatory studies—

Countries

Japan

Contacts

Public ContactKenji Omae

Fukushima Medical University Hospital Department of Innovative Research and Education for Clinicians and Trainees (DiRECT)

omae416@fmu.ac.jp0245471471

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026