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

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ClinicalTrials.gov Identifier: NCT03987633
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Future Genetics Limited

Brief 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.


Condition or disease
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

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Estimated Study Start Date : August 5, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2024

Group/Cohort
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.



Primary Outcome Measures :
  1. Ethnic disparities in treatment failure [ Time Frame: Ongoing 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.


Secondary Outcome Measures :
  1. Ethnic disparities in disease incidence [ Time Frame: Ongoing review of data, anticipated completion of analysis 5 years post launch ]
    Identifying ethnic disparities in disease incidence. The corresponding secondary outcome measure for this is, for each of the 19 diseases under consideration, the diagnosis of the disease. We will use time to diagnosis to examine ethnic disparities in incidence.

  2. Identification of candidate genetic variants associated with observed disparities in treatment failure. [ Time Frame: Ongoing review of data, anticipated completion of analysis 5 years post launch ]
    Another secondary outcome is identifying candidate genetic variants that may underpin observed disparities in treatment failure, for treatments in the 19 diseases under consideration. The corresponding secondary outcome measures used for this are genotypes as identified through whole genome sequencing (WGS) of patient saliva or peripheral blood that are associated with the phenotypes corresponding to the treatment failure previously described as the primary outcome measure.


Biospecimen Retention:   Samples With DNA
Saliva. Where practical, blood or other biological samples may also be voluntarily provided by the patient.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals who are registered as UK NHS patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987633


Contacts
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Contact: Dr Mohammed Kamran 00441216673007 director@futuregenetics.co.uk

Locations
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United Kingdom
Future Genetics Limited Not yet recruiting
Birmingham, West Midlands, United Kingdom, B15 2SQ
Contact: Dr Mohammed Kamran, PhD    00441216673007    director@futuregenetics.co.uk   
Sponsors and Collaborators
Future Genetics Limited
Investigators
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Study Director: Dr Mohammed Kamran Future Genetics Limited

Additional Information:
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Responsible Party: Future Genetics Limited
ClinicalTrials.gov Identifier: NCT03987633     History of Changes
Other Study ID Numbers: EMPOWER-1
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Future Genetics Limited:
genetic disparity
health inequality
genetics
health outcomes
equality

Additional relevant MeSH terms:
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Diabetes Mellitus
Heart Failure
Arthritis, Rheumatoid
Atrial Fibrillation
Lung Diseases
Kidney Diseases
Cardiovascular Diseases
Lung Diseases, Obstructive
Heart Diseases
Pulmonary Disease, Chronic Obstructive
Renal Insufficiency, Chronic
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arrhythmias, Cardiac
Pathologic Processes
Respiratory Tract Diseases