At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 120 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 6 Years and over
- Who
- All
- Number of participants
- 200,000
- Started
- 2020-02-01
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation
- • Clinical study - 200,000 participants
- • Health inequality and genetic disparity are a significant issue in the United Kingdom (UK)
Who can take part?
- • Ages 6 Years and over
- • Diagnosed with atrial fibrillation
Where?
- • Wolverhampton - Future Genetics, The Science Centre, Wolverhampton Science Park
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patients or their relative/family member is diagnosed with the illness being investigated by this study.
- ✓Subjects agree to:
- ✓Gift biological samples, i.e. saliva. Where practical, blood or other biological samples may be voluntarily provided...
- ✓Provide Consent for access to medical records.
- ✓Complete disease specific, quality of life, and study associated questionnaires.
Who cannot take part
- ✗Patient does not provide a valid consent for study participation.
- ✗Patient is not registered with the NHS for care.
- ✗Patient lacking capacity, who does not have an illness that is being specifically investigated by this clinical...
- ✗Person lacks capacity and where the personal consultee has not advised that the Person may enrol, in accordance with...
See the full criteria
Where Is This Study? (1 UK site)
Future Genetics, The Science Centre, Wolverhampton Science Park
Wolverhampton WV10 9RU, United Kingdom
How to Get in Touch
Dr Mohammed Kamran
Sponsor contactCONTACT