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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: t
View:

• Patients or their relative/family member is diagnosed with the illness being investigated by this study.

• All NHS patients that are associated with a participating study site, but do not fall under the first bullet point above, may participate with a view that they may potentially contribute to a case control population in the research study.

• Subjects agree to:

‣ Gift biological samples, i.e. saliva. Where practical, blood or other biological samples may be voluntarily provided by the patient.

⁃ Provide Consent for access to medical records.

⁃ Complete disease specific, quality of life, and study associated questionnaires.

Locations
Other Locations
United Kingdom
Future Genetics, The Science Centre, Wolverhampton Science Park
RECRUITING
Wolverhampton
Contact Information
Primary
Dr Mohammed Kamran
director@futuregenetics.co.uk
00441216673007
Time Frame
Start Date: 2020-02-01
Estimated Completion Date: 2030-02-01
Participants
Target number of participants: 200000
Treatments
Displaying trait of interest
There are 19 disease areas under investigation. Enrolled patients are segmented into cohorts based on data collected through questionnaires and medical histories. This data-driven approach does not allow for precisely predefined cohorts for the diseases under investigation. Therefore, as a default, the two general predefined cohorts are set as either displaying or not displaying a trait that would form the basis of an investigation.
Not displaying trait of interest
Please see above.
Sponsors
Leads: Future Genetics Limited

This content was sourced from clinicaltrials.gov