Randomised trials in cardiovascular and metabolic disease
Lead Research Organisation:
University of Oxford
Abstract
The aim of this programme is to demonstrate reliably any benefits of treatments that can be widely used in common diseases such as heart disease, diabetes and kidney disease. Even quite modest improvements in outcome in common conditions can lead to important benefits for patients. In order to be sure that treatments really work, large numbers of people usually need to be given the treatment and compared with similar people not given the treatment. The most reliable way to do this is using randomisation, a method whereby the decision about who receives a treatment is determined by chance (like tossing a coin). In order to help provide reliable results, these randomised trials also often involve masking (or blinding) the treatment so that neither the participants nor their doctors or nurses know if they are taking an active or dummy treatment. Over the past several years, we have pioneered ways of running randomised trials involving thousands of people efficiently and cost-effectively to gain reliable information. We have developed a wide experience of using IT and centrally-held health records to streamline the running of large trials. Ongoing studies include testing a cholesterol-lowering drug added to statin therapy in people at high risk of heart problems, a new treatment for kidney disease and testing an established medication to investigate whether it can slow the worsening of eye disease in people with diabetes.
Technical Summary
This programme aims to generate reliable evidence about interventions with potential for significant public health benefit. Treatments with even modest effects in common diseases (such as vascular disease, diabetes or chronic kidney disease) may make significant contributions to reducing morbidity and mortality globally. Building on epidemiological evidence and other data generated in PHRU, CTSU and elsewhere, we aim to deliver large-scale randomised evidence to determine the efficacy and safety of treatments in cardiovascular and metabolic disease. Along with smoking and blood pressure, blood lipids are a major cause of cardiovascular disease, a major cause of morbidity and mortality worldwide. Higher levels of LDL cholesterol and lower levels of HDL cholesterol are associated with higher risks of coronary heart disease. Partly as a result of our large randomised trials (HPS, SEARCH and SHARP) and meta-analyses, statins, which effectively lower LDL cholesterol, are now very widely used for both primary and secondary prevention of cardiovascular disease. However some patients remain at high risk despite statin use, thus additional safe treatments to modify risk are needed. Attention is now turning to newer drugs which modulate lipids by other mechanisms. The effects of such treatments on top of statins are likely to be modest, so large-scale randomised evidence is required to assess their effects reliably, hence the ORION-4 trial of a silencing RNA to PCSK9 (inclisiran) will recruit 15,000 people at high risk of cardiovascular disease. Participants will receive 6-monthly injections of inclisiran or placebo and be followed for at least 5 years at large streamlined clinics based in the UK and USA. Recent trials of sodium glucose co-transporter 2 inhibitors (SGLT2i) have shown they reduce the risk of cardiovascular disease (in particular heart failure) and progression of kidney disease among patients with diabetes. The mechanism by which SGLT2i affect kidney function does not require the presence of diabetes, so an important question in nephrology is whether SGLT2i also reduce the risk of cardiovascular disease and progression of kidney disease among patients with established chronic kidney disease, regardless of whether they have diabetes or not. The EMPA-KIDNEY trial will recruit at least 5000 participants with chronic kidney disease (at least a third with and a third without diabetes) and compare the effect of empagliflozin 10 mg daily versus placebo on a cardiorenal primary outcome. The LENS trial is also comparing an established treatment (fenofibrate) among participants with diabetic eye disease to test the hypothesis (raised by other trials) that fenofibrate may delay the progression of retinopathy.
Over the last several years, PHRU has developed streamlined methods to recruit large numbers of patients and conduct trials efficiently as well as cost-effectively (e.g. ASCEND), including using record linkage to facilitate follow-up, both during the trials (e.g. ASCEND, 3C, LENS) and in the longer-term (e.g. HPS, SEARCH). Such efforts will continue in the next quinquennium (including using the ongoing trials as laboratories for such methodological development) so that the outputs from this programme will not only be reliable answers to important questions in the treatment of cardiovascular and metabolic disease, but also rapidly transferable information on how to conduct such trials for use by the wider trials community.
Over the last several years, PHRU has developed streamlined methods to recruit large numbers of patients and conduct trials efficiently as well as cost-effectively (e.g. ASCEND), including using record linkage to facilitate follow-up, both during the trials (e.g. ASCEND, 3C, LENS) and in the longer-term (e.g. HPS, SEARCH). Such efforts will continue in the next quinquennium (including using the ongoing trials as laboratories for such methodological development) so that the outputs from this programme will not only be reliable answers to important questions in the treatment of cardiovascular and metabolic disease, but also rapidly transferable information on how to conduct such trials for use by the wider trials community.
Organisations
- University of Oxford, United Kingdom (Lead Research Organisation)
- NHS Scotland, United Kingdom (Collaboration)
- Public Health England, Salisbury (Collaboration)
- King's Mill Hospital (Collaboration)
- Northgate Public Services (Collaboration)
- Gloucestershire Royal Hospital (Collaboration)
- Farnham Hospital (Collaboration)
- Hertford County Hospital (Collaboration)
- Regeneron Pharmaceuticals, Inc. (Collaboration)
- Mylan (Collaboration)
- Glenfield Hospital (Collaboration)
- University of Wuerzburg, Germany (Collaboration)
- Doncaster and Bassetlaw Hospitals NHS Foundation Trust (Collaboration)
- Homerton University Hospital (Collaboration)
- Hull Royal Infirmary, United Kingdom (Collaboration)
- University of British Columbia, Canada (Collaboration)
- Public Health Wales NHS Trust, United Kingdom (Collaboration)
- National Institute for Health Research, United Kingdom (Collaboration)
- John Radcliffe Hospital, United Kingdom (Collaboration)
- Birmingham Heartlands Hospital (Collaboration)
- Norfolk and Norwich University Hospitals NHS Foundation Trust (Collaboration)
- NHS England, United Kingdom (Collaboration)
- Bexhill Hospital (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- Associazione Nazionale Medici Cardiologi Ospedalieri (Collaboration)
- Duke University, United States (Collaboration)
- North Ormesby Health Village (Collaboration)
- Eagle Bridge Health and Wellbeing Centre (Collaboration)
- Roche Pharmaceuticals (Collaboration)
- Mid Yorkshire Hospitals NHS Trust (Collaboration)
- Moorfields Eye Hospital (Collaboration)
- Health Intelligence Ltd (Collaboration)
Publications

Brott TG
(2019)
Long-term outcomes of stenting and endarterectomy for symptomatic carotid stenosis: a preplanned pooled analysis of individual patient data.
in The Lancet. Neurology

Chan MS
(2021)
A Biomarker-based Biological Age in UK Biobank: Composition and Prediction of Mortality and Hospital Admissions.
in The journals of gerontology. Series A, Biological sciences and medical sciences

Collins R
(2020)
Randomization versus Real-World Evidence. Reply.
in The New England journal of medicine

Fraser AG
(2020)
Regulating drugs, medical devices, and diagnostic tests in the European Union: early lessons from the COVID-19 pandemic?
in European heart journal

Goonasekera MA
(2020)
LDL-cholesterol reduction in chronic kidney disease: options beyond statins.
in Current opinion in nephrology and hypertension

Haynes R
(2020)
Chronic kidney disease, heart failure and neprilysin inhibition.
in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association


Herrington WG
(2021)
Cardiac, renal, and metabolic effects of sodium-glucose co-transporter 2 inhibitors: a position paper from the European Society of Cardiology ad-hoc task force on sodium-glucose co-transporter 2 inhibitors.
in European journal of heart failure

Herrington WG
(2020)
Kidney disease trials for the 21st century: innovations in design and conduct.
in Nature reviews. Nephrology

Hopewell JC
(2020)
Independent risk factors for simvastatin-related myopathy and relevance to different types of muscle symptom.
in European heart journal
Guideline Title | WHO COVID-19 guidelines |
Description | Influence on international treatmen guidelines for COVID-19 |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Impact | It has been estimated that implementation of RECOVERY dexamethasone result has saved over 1000000 lives globally. |
Description | RECOVERY Trial |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Influenced training of practitioners or researchers |
Impact | The RECOVERY Trial investigates treatments to tackle COVID-19. It is the world's largest such trail and since it began in 2020, it has produced definitive results for a number of treatments that have informed clinical practice around the world. As a result, the deadly impact of COVID has dramatically reduced. |
URL | http://www.recoverytrial.net |
Description | RECOVERY/Phase 2 Therapeutic Trials Reconfiguration |
Amount | £17,999,777 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 11/2020 |
End | 11/2022 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Bexhill Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Birmingham Heartlands Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Doncaster and Bassetlaw Hospitals NHS Foundation Trust |
Department | Diabetes & Endocrine Centre, Doncaster Royal Infirmary |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Eagle Bridge Health and Wellbeing Centre |
Country | United Kingdom |
Sector | Public |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Farnham Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Glenfield Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Gloucestershire Royal Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Hertford County Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Homerton University Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Hull Royal Infirmary |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | John Radcliffe Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | King's Mill Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Mid Yorkshire Hospitals NHS Trust |
Country | United Kingdom |
Sector | Public |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Moorfields Eye Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | NHS England |
Country | United Kingdom |
Sector | Public |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Norfolk and Norwich University Hospitals NHS Foundation Trust |
Country | United Kingdom |
Sector | Public |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | North Ormesby Health Village |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Northgate Public Services |
Country | United Kingdom |
Sector | Private |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Public Health England |
Department | Bristol and Weston Diabetic Eye Screening Programme |
Country | United Kingdom |
Sector | Public |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | ASCEND-Eye Diabetic Eye Screening Programme |
Organisation | Public Health Wales NHS Trust |
Country | United Kingdom |
Sector | Public |
PI Contribution | The ASCEND-Eye study will use linked data from the NHS Diabetic Eye Screening Programme (DESP) to determine whether aspirin or omega-3 fatty acids alter the course of diabetic retinopathy or diabetic maculopathy. Each partnering DESP is facilitating the data linkage by identifying appropriate staff to run a query on their local database, or to facilitate the software provider to extract data on their behalf. |
Collaborator Contribution | academic collaboration |
Impact | n/a |
Start Year | 2019 |
Description | EMPA Kidney regional coordinating centres |
Organisation | Associazione Nazionale Medici Cardiologi Ospedalieri |
Country | Italy |
Sector | Charity/Non Profit |
PI Contribution | 1. Duke Clinical Research Institute, Durham USA: DCRI is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to DCRI. DCRI coordinates all activities for the trial in the US including management of 55 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 2. University of British Columbia, Vancouver Canada. UBC is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UBC. UBC coordinates all activities for the trial in the US including management of 20 clinical centres and recruitment of 500 participants. This collaboration began in 2018 and is ongoing. 3. University of Wurzburg, Wurzburg Germany. UW is the German Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UW. UW coordinates all activities for the trial in Germany including management of 35 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 4. National Centre for CKD Research, Nanjing China. Nanjing is part of the China Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to Nanjing. Nanjing coordinates all activities for the trial in China including management of 25 clinical centres and recruitment of 1000 participants. This collaboration began in 2018 and is ongoing. 5. Associazione Nazionale Medici Cardiologi Ospedalieri which we have a contract with to deliver EMPA-KIDNEY in Italy. ANMCO is overseeing about 20 sites. |
Collaborator Contribution | research collaboration |
Impact | 2020-recruitment phase |
Start Year | 2019 |
Description | EMPA Kidney regional coordinating centres |
Organisation | Duke University |
Department | Duke Clinical Research Institute |
Country | United States |
Sector | Academic/University |
PI Contribution | 1. Duke Clinical Research Institute, Durham USA: DCRI is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to DCRI. DCRI coordinates all activities for the trial in the US including management of 55 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 2. University of British Columbia, Vancouver Canada. UBC is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UBC. UBC coordinates all activities for the trial in the US including management of 20 clinical centres and recruitment of 500 participants. This collaboration began in 2018 and is ongoing. 3. University of Wurzburg, Wurzburg Germany. UW is the German Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UW. UW coordinates all activities for the trial in Germany including management of 35 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 4. National Centre for CKD Research, Nanjing China. Nanjing is part of the China Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to Nanjing. Nanjing coordinates all activities for the trial in China including management of 25 clinical centres and recruitment of 1000 participants. This collaboration began in 2018 and is ongoing. 5. Associazione Nazionale Medici Cardiologi Ospedalieri which we have a contract with to deliver EMPA-KIDNEY in Italy. ANMCO is overseeing about 20 sites. |
Collaborator Contribution | research collaboration |
Impact | 2020-recruitment phase |
Start Year | 2019 |
Description | EMPA Kidney regional coordinating centres |
Organisation | University of British Columbia |
Country | Canada |
Sector | Academic/University |
PI Contribution | 1. Duke Clinical Research Institute, Durham USA: DCRI is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to DCRI. DCRI coordinates all activities for the trial in the US including management of 55 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 2. University of British Columbia, Vancouver Canada. UBC is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UBC. UBC coordinates all activities for the trial in the US including management of 20 clinical centres and recruitment of 500 participants. This collaboration began in 2018 and is ongoing. 3. University of Wurzburg, Wurzburg Germany. UW is the German Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UW. UW coordinates all activities for the trial in Germany including management of 35 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 4. National Centre for CKD Research, Nanjing China. Nanjing is part of the China Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to Nanjing. Nanjing coordinates all activities for the trial in China including management of 25 clinical centres and recruitment of 1000 participants. This collaboration began in 2018 and is ongoing. 5. Associazione Nazionale Medici Cardiologi Ospedalieri which we have a contract with to deliver EMPA-KIDNEY in Italy. ANMCO is overseeing about 20 sites. |
Collaborator Contribution | research collaboration |
Impact | 2020-recruitment phase |
Start Year | 2019 |
Description | EMPA Kidney regional coordinating centres |
Organisation | University of Wurzburg |
Country | Germany |
Sector | Academic/University |
PI Contribution | 1. Duke Clinical Research Institute, Durham USA: DCRI is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to DCRI. DCRI coordinates all activities for the trial in the US including management of 55 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 2. University of British Columbia, Vancouver Canada. UBC is the US Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UBC. UBC coordinates all activities for the trial in the US including management of 20 clinical centres and recruitment of 500 participants. This collaboration began in 2018 and is ongoing. 3. University of Wurzburg, Wurzburg Germany. UW is the German Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to UW. UW coordinates all activities for the trial in Germany including management of 35 clinical centres and recruitment of 1250 participants. This collaboration began in 2018 and is ongoing. 4. National Centre for CKD Research, Nanjing China. Nanjing is part of the China Regional Coordinating Centre for EMPA-KIDNEY paid by a grant from University of Oxford to Nanjing. Nanjing coordinates all activities for the trial in China including management of 25 clinical centres and recruitment of 1000 participants. This collaboration began in 2018 and is ongoing. 5. Associazione Nazionale Medici Cardiologi Ospedalieri which we have a contract with to deliver EMPA-KIDNEY in Italy. ANMCO is overseeing about 20 sites. |
Collaborator Contribution | research collaboration |
Impact | 2020-recruitment phase |
Start Year | 2019 |
Description | Health Intelligence Limited |
Organisation | Health Intelligence Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | Health Intelligence Ltd did not request payment for the script development or data processing. |
Collaborator Contribution | Northgate linked NHS Diabetic Eye Screening data for 11 collaborating DESPs. Those DESPs were: BER Berkshire DESP BRI Bristol and Weston DESP DEV Devon DESP DOR Dorset DESP EAN East Anglia DESP ESX Essex DESP GMN Greater Manchester North DESP GMS Greater Manchester South DESP HIW Hampshire and Isle of Wight NWL North West London DESP PCT Kent and Medway DESP |
Impact | Analyses of all DESP linkage data received are ongoing. Data sharing agreement produced with the input of UnioOx Research Services. Fully executed: 23rd August 2021 |
Start Year | 2020 |
Description | LENS Trial |
Organisation | Mylan |
Country | Global |
Sector | Private |
PI Contribution | conduct of LENS trial |
Collaborator Contribution | Mylan - provision of study treatment (placebo and fenofibrate) NHS Scotland - (i) provision of pseudonymised data for follow up (ii) data to allow invitation of participants |
Impact | n/a |
Start Year | 2019 |
Description | LENS Trial |
Organisation | NHS Scotland |
Country | United Kingdom |
Sector | Public |
PI Contribution | conduct of LENS trial |
Collaborator Contribution | Mylan - provision of study treatment (placebo and fenofibrate) NHS Scotland - (i) provision of pseudonymised data for follow up (ii) data to allow invitation of participants |
Impact | n/a |
Start Year | 2019 |
Description | Northgate Public Services Limited |
Organisation | Northgate Public Services |
Country | United Kingdom |
Sector | Private |
PI Contribution | £18,850 was paid to Northgate for the linkage script development and data processing. This was funded by a BHF CRE awarded to E Sammons. |
Collaborator Contribution | Northgate linked NHS Diabetic Eye Screening data for 15 collaborating DESPs. Those DESPs were: BSW Bath NE Somerset Swindon and Wiltshire DESP SUR Surrey DESP SWL South West London DESP HER Arden Herefordshire and Worcestershire DESP NTG North of Tyne and Gateshead DESP MER Central Mersey WRC West Riding and Craven DESP ENH East and North Hertfordshire HUM Humber DESP OXF Oxfordshire DESP SES South East Sussex DESP CHS Cheshire DESP NNT North Nottinghamshire NOT Greater Nottingham YOR North Yorkshire DESP |
Impact | Analyses of all DESP linkage data received are ongoing. A Contract for Professional Services was produced with the input of UnioOx Research Services which outlined the development of a linkage script and the data processing relationship relevant to the data transfers. Fully executed: 27th January 2020 |
Start Year | 2019 |
Description | RECOVERY Trial |
Organisation | National Institute for Health Research |
Department | NIHR Clinical Research Network (CRN) |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | RECOVERY collaborates with NIHR Clinical Research Network who provide staff at many of the hospitals in England and assist with delivery; NHS Blood & Transplant who collected and distributed convalescent plasma for that comparison; Roche (who provided tocilizumab but no funding); Regeneron (who provided REGN-COV2 but no funding); |
Collaborator Contribution | RECOVERY collaborates with NIHR Clinical Research Network who provide staff at many of the hospitals in England and assist with delivery; NHS Blood & Transplant who collected and distributed convalescent plasma for that comparison; Roche (who provided tocilizumab but no funding); Regeneron (who provided REGN-COV2 but no funding); |
Impact | An understanding of the treatments that are effective, or not effective, on COVID-19 |
Start Year | 2020 |
Description | RECOVERY-GSK/Vir |
Organisation | GlaxoSmithKline (GSK) |
Country | Global |
Sector | Private |
PI Contribution | Randomised assessment of sotrovimab in patients with severe COVID-19 |
Collaborator Contribution | Provision of sotrovimab free of charge to sites |
Impact | None to date; trial ongoing. |
Start Year | 2021 |
Description | RECOVERY-Regeneron |
Organisation | Regeneron Pharmaceuticals, Inc. |
Country | United States |
Sector | Private |
PI Contribution | Randomised assessment of casirivimab+imdevimab among 9000 people with severe COVID-19 |
Collaborator Contribution | Provision of casirivimab+imdevimab free of charge to trial sites |
Impact | Lancet publication Regulatory license applications globally. Change in clinical practice. |
Start Year | 2020 |
Description | RECOVERY-Roche |
Organisation | Roche Pharmaceuticals |
Country | Global |
Sector | Private |
PI Contribution | RECOVERY trial randomised assessment of tocilizumab for severe COVID-19. |
Collaborator Contribution | Tocilizumab provided to trial sites free of charge by Roche. |
Impact | Lancet publication. Supported Emergency Use Authorisation and regulatory license applications in over 50 countries to date. |
Start Year | 2020 |
Description | ASCEND Dementia results |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | AHA presentation of the ASCEND Dementia results and associated media activity 15 Nov 2021 - Jane A |
Year(s) Of Engagement Activity | 2021 |
Description | ASCEND PLUS patient group meetings |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Study participants or study members |
Results and Impact | Patient group meetings online on 17 June 2021 (NDPH panel), 26 July 2021 (Research for the Future panel, North of England [1]), 28 July 2021 (Research for the Future panel, North of England [2]), 8 September 2021 (Wales), 27 November 2021 (Scotland), 11 November 2021 (Centre for Ethnic Health Research, Leicester) - to discuss design of ASCEND PLUS trial Creation of ASCEND PLUS Patient Advisory Group; meetings on 6th Sept 2021 and 8th Feb 2022 |
Year(s) Of Engagement Activity | 2021 |
Description | Diabetes and Cardiovascular disease - the Mexican Experience |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Diabetes and Cardiovascular disease - the Mexican Experience. International Diabetes Federation Virtual Conference 2021 Masterclass. 8th December 2021. |
Year(s) Of Engagement Activity | 2021 |
Description | ERA-EDTA Clinical Kidney Journal monthly podcast |
Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Public/other audiences |
Results and Impact | ERA-EDTA Clinical Kidney Journal Monthly Podcast - podcast lead editor: (https://www.era-edta.org/en/education/ckj-journal-club-e-seminars/) - Mar 2021: The complexity of sleep disorders in dialysis patients - Apr 2021: Global Longitudinal Strain by Feature Tracking Cardiovascular MRI Predicts Mortality in Patients with End Stage Kidney Disease - May 2021: Eculizumab discontinuation in atypical haemolytic uremic syndrome: TMA recurrence risk and renal outcomes - June 2021: Rapid decline of anti-SARS-CoV-2 antibodies in patients on haemodialysis: the COVID-FRIAT study - Sept 2021: Cycling during haemodialysis - results from PEDAL and CYCLE-HD - Oct 2021: Management of post-transplant diabetes mellitus: an opportunity for novel therapeutics - Nov 2021: Monitoring anti-PLA2R antibody titres to predict the likelihood of spontaneous remission of membranous nephropathy - Jan 2022: Robot-assisted transplantation |
Year(s) Of Engagement Activity | 2021,2022 |
URL | https://www.era-edta.org/en/education/ckj-journal-club-e-seminars/ |
Description | Genetic analyses link obesity to risk of kidney disease, so what can we do about it? |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Genetic analyses link obesity to risk of kidney disease, so what can we do about it? Kidney Research UK - Driving Discoveries: Celebrating our 60th anniversary. 21st October 2021. |
Year(s) Of Engagement Activity | 2021 |
Description | HRA Ethics Review Workshop |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Scientific adviser |
Year(s) Of Engagement Activity | 2020 |
Description | International Alport Research |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Talk to International Alport Research patient webinar about potential of SGLT-2 inhibitors in Alport Syndrome |
Year(s) Of Engagement Activity | 2021 |
Description | Kidney Care UK webinars |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Webinar series for kidney patients |
Year(s) Of Engagement Activity | 2020,2021 |
Description | NHS Digitrials online engagement events |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Study participants or study members |
Results and Impact | I November 2020 I took part in a series of Zoom events with members of the public to discuss NHS data policies |
Year(s) Of Engagement Activity | 2020 |
Description | ORION-4 press announcement |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | I was involved in some of the press activity around the announcement of the ORION-17 trial, including answering questions for the BHF and the Sun |
Year(s) Of Engagement Activity | 2019 |
Description | Panel Discussant. Session 6: Contactless/decentralized/virtual trials/registry trials in CKD: challenges and opportunities |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Panel Discussant. Session 6: Contactless/decentralized/virtual trials/registry trials in CKD: challenges and opportunities. 6th Kidney Disease Clinical Trialists Workshop. 30th October 2021. |
Year(s) Of Engagement Activity | 2021 |
Description | RECOVERY Participant Panel |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | RECOVERY trial participant panel. |
Year(s) Of Engagement Activity | 2020,2021,2022 |
Description | RECOVERY Trial |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | National and international media coverage as a result of my involvement in the world's largest trial investigating COVID-19 treatments, the RECOVERY Trial |
Year(s) Of Engagement Activity | 2020,2021 |
URL | http://www.recoverytrial.net |
Description | SGLT-2 inhibitor guidelines in CKD. |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | SGLT-2 inhibitor guidelines in CKD. Proposer, chair and speaker for pop-up session at UK Kidney Week October 2021. |
Year(s) Of Engagement Activity | 2021 |
Description | SGLT-2 inhibitors - treatment for diabetic and nondiabetic kidney disease |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | SGLT-2 inhibitors - treatment for diabetic and nondiabetic kidney disease. Royal College of Edinburgh Renal Medicine Online Symposium. 22nd April 2021. |
Year(s) Of Engagement Activity | 2021 |
Description | SGLT2i: an update for nephrologists |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | SGLT2i: an update for nephrologists. Clinical Research Network Kent, Surrey Sussex meeting. 13th October 2021 |
Year(s) Of Engagement Activity | 2021 |
Description | Trials and tribulations of research in nephrology: Historical perspective and hope for patients. |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Trials and tribulations of research in nephrology: Historical perspective and hope for patients. Special Session: Capacity Building: The need for dedicated training programs and innovative trial design. Virtual World Congress of Nephrology (WCN'21), April 15-19, 2021 |
Year(s) Of Engagement Activity | 2021 |
Description | UK Renal Trials Network update session |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | UK Renal Trials Network update session. Proposer and session main chair at UK Kidney Week. October 2021 |
Year(s) Of Engagement Activity | 2021 |
Description | World Congress of Nephrology: SGLT2 Inhibition From the Bench to Clinic |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | World Congress of Nephrology: SGLT2 Inhibition From the Bench to Clinic: All That You Need to Know Clinical Trials Data in Diabetic Nephropathy, Cardiovascular Disease, and Proteinuric CKD. Invited talk for Mar 2022 |
Year(s) Of Engagement Activity | 2022 |