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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	6 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03987633
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Future Genetics Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dr Mohammed Kamran
Principal Investigator Affiliation	Future Genetics Limited
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atrial 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
Study Website:	View Trial Website

Additional Details

This multi-centre real-world study will recruit patients across different National Health Service (NHS) sites based in England, where the overall patient population demographic profile is sufficiently variable to allow for meaningful representation of different ethnicities in the analysis of pooled data-sets. The study addresses the issue of health inequality and genetic disparity in the United Kingdom (UK) by recruiting up to 200,000 patients primarily from the three main ethnic groups in the UK; namely White (Caucasian), African-Caribbean (Black), and South Asian (Asian) populations on a 1:1:1 ratio. Biological samples, medical records, alongside specific questionnaires will be used in data analyses to help identify treatment failures in different populations for the 19 disease areas under investigation, which are a significant cause of morbidity and mortality in the UK. Analysis of patient populations may provide real-world evidence around disease prevalence between and within different ethnic groups. The data may also support hypothesis driven genetic analysis to identify putative bio-markers associated with treatment failure. Data from this study will be published, and findings could better inform clinical practice in the management of diseases that cause significant poor health and death in the different populations that represent the UK.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Wolverhampton, West Midlands, United Kingdom

Status

Recruiting

Address

Future Genetics, The Science Centre, Wolverhampton Science Park

Wolverhampton, West Midlands, WV10 9RU

Site Contact

Mohammed Kamran, PhD

[email protected]

00441216673007

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