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.

Organisations

Publications

10 25 50

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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

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

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

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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

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

 
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