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EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality

NCT03987633 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200000

Last updated 2025-03-10

No results posted yet for this study

Summary

Health inequality and genetic disparity are a significant issue in the United Kingdom (UK).

This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations.

The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations.

This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK.

The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.

Conditions

Sponsors & Collaborators

  • Future Genetics Limited

    lead OTHER

Principal Investigators

  • Dr Mohammed Kamran · Future Genetics Limited

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2028-02-01
Completion
2030-02-01

Countries

  • United Kingdom

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 NCT03987633 on ClinicalTrials.gov