EMPOWER-1:Multi-site clinical cohort study to reduce health inequality
Research type
Research Study
Full title
EMPOWER-1: A multi-site clinical cohort study to reduce health inequality: identifying ethnic disparities in treatment failures for medicines prescribed to treat diseases that cause significant mortality and morbidity in the UK population
IRAS ID
259782
Contact name
Mohammed Kamran
Contact email
Sponsor organisation
Future Genetics Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 29 days
Research 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
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0296
Date of REC Opinion
16 Jan 2020
REC opinion
Further Information Favourable Opinion