Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT03987633

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionAtrial Fibrillation, Coronary Heart Disease, Cardiovascular Diseases, Heart Failure, Hypertension, Peripheral Arterial Disease, Stroke, Ischemic, Asthma, Chronic Obstructive Pulmonary Disease, Obesity, Cancer, Chronic Kidney Diseases, Diabetes Mellitus, Dementia, Depression, Epilepsy, Mental Health Disorder, Rheumatoid Arthritis, Blood Pressure, Breast Cancer Risk, Prostate Cancer, Lung Cancers

Full registry criteria

Inclusion Criteria: 1. Patients or their relative/family member is diagnosed with the illness being investigated by this study. 2. 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. 3. Subjects agree to: 1. Gift biological samples, i.e. saliva. Where practical, blood or other biological samples may be voluntarily provided by the patient. 2. Provide Consent for access to medical records. 3. Complete disease specific, quality of life, and study associated questionnaires. Exclusion Criteria: 1. Patient does not provide a valid consent for study participation. 2. Patient is not registered with the NHS for care. 3. Patient lacking capacity, who does not have an illness that is being specifically investigated by this clinical research study. 4. Person lacks capacity and where the personal consultee has not advised that the Person may enrol, in accordance with the Mental Health Act 2005.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Ethnic disparities in treatment failureOngoing review of data, anticipated completion of primary outcome analysis 4 years post launch

Identify ethnic disparities in treatment failures for any of the 19 disease states under investigation. The primary outcome is treatment failure, as measured by the discontinuation of a treatment regimen by a clinician in the absence of the cure of the disease, for the most common treatment in each of the 19 diseases.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Future Genetics, The Science Centre, Wolverhampton Science Park🇬🇧 Wolverhampton, West Midlands, United Kingdom

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Mohammed Kamran, PhDContact

Email · Call 00441216673007