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Emulation of the KEYNOTE-189 Trial Using Electronic Health Records

NCT05908799 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1854

Last updated 2023-09-13

No results posted yet for this study

Summary

Investigators are building an empirical evidence base supporting the utility of real-world data through the emulation of randomized controlled trials in the oncology setting. The purpose of this work is to demonstrate whether real-world evidence studies can provide reliable conclusions on treatment effectiveness to inform further applications of real-world data in pharmaceutical product label expansion, post-marketing safety, and other purposes that are complementary to RCTs.

Conditions

Interventions

DRUG

Pembrolizumab + Pemetrexed-Platinum

Medication records in EHR database used to define exposure group

DRUG

Pemetrexed-Platinum

Medication records in EHR database used to define comparator group

Sponsors & Collaborators

  • Aetion, Inc.

    lead OTHER

Principal Investigators

  • David Merola, PharmD, PhD · Aetion, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908799 on ClinicalTrials.gov