NCT03987633 EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality
| NCT ID | NCT03987633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Future Genetics Limited |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200,000 participants |
| Start Date | 2020-02-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200,000 participants in total. It began in 2020-02-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Dr Mohammed Kamran
STUDY DIRECTOR
Future Genetics Limited
Frequently Asked Questions
Who can join the NCT03987633 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03987633 currently recruiting?
Yes, NCT03987633 is actively recruiting participants. Contact the research team at director@futuregenetics.co.uk for enrollment information.
Where is the NCT03987633 trial being conducted?
This trial is being conducted at Wolverhampton, United Kingdom.
Who is sponsoring the NCT03987633 clinical trial?
NCT03987633 is sponsored by Future Genetics Limited. The principal investigator is Dr Mohammed Kamran at Future Genetics Limited. The trial plans to enroll 200,000 participants.
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