NCT03987633Recruiting
EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality
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
Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200000 (estimated)
- First submitted
- 12 Jun 2019
- Start date
- 1 Feb 2020
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Future Genetics Limited
- Diseases
- Prostate cancer, Epilepsy, Chronic kidney disease, Heart failure, Obesity, Coronary artery disease, Stroke, Asthma, Atrial fibrillation, Rheumatoid arthritis, COPD, High blood pressure, Lung cancer, Childhood cancers
- NCT number
- NCT03987633
What you commit to
- Study type: Observational
- Planned participants: 200000
- From 1 Feb 2020 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient lacking capacity, who does not have an illness that is being specifically investigated by this clinical research study.
Other
- Patient does not provide a valid consent for study participation.
- Patient is not registered with the NHS for care.
- Person lacks capacity and where the personal consultee has not advised that the Person may enrol, in accordance with the Mental Health Act 2005.
Who the study is looking for
- 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.
Age in the registry: 6 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Future Genetics, The Science Centre, Wolverhampton Science Park Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.