CTSU resubmission: Proposal to increase capacity for methodological improvements in clinical trials
Lead Research Organisation:
Medical Research Council
Department Name: UNLISTED
Abstract
Oxford University?s Clinical Trial Service Unit already provides methodological advice across the different phases of major clinical trials (design, conduct, analysis and interpretation) to a large number of research groups in Oxford, elsewhere in the UK and internationally. It aims to improve the quality of these trials (e.g. more patients recruited more rapidly; better data quality and study conduct) in order that they generate more reliable evidence about the effects of treatments on mortality and major morbidity. MRC hub funding would be used by the CTSU to increase its leadership role in two main areas. Firstly, providing guidance to clinical experts on the design and conduct of trials (chiefly in vascular and neoplastic diseases); and, secondly, developing efficient and secure IT systems to facilitate the conduct of large-scale trials. More reliable evidence from better trials should lead to substantial improvements in public health.
Technical Summary
The CTSU has had productive collaborations over a long period with clinical trial units and researchers locally, nationally and internationally. There are increasing demands on us for help with the methodological support of clinical trials, and our previous use of core funding to support these activities has been very cost-effective. The MRC?s plan to establish clinical trial hubs recognises the need for this type of work. But, the extent to which the CTSU is currently able to provide such support for trials is severely limited by the available resources. MRC hub funding would allow the CTSU to extend its innovative methodological work on trials. In particular, this funding would be used to support the time of senior scientific staff to help external researchers develop trials that address key clinical questions reliably, and senior IT staff to help develop innovative methods for conducting trials more efficiently and effectively. It would also allow the CTSU to develop further our local and national collaborations with other clinical trials units and to help with streamlining clinical trial regulatory procedures, as well as to increase our capacity for training. MRC hub support would be accessible to external researchers via the CTSU web-site and/or via direct contact with members of the CTSU staff.
In December 2007, the CTSU had a quinquennial review by the MRC, and the review panel gave us the maximum overall rating of 6 out of 6 (?exceptional and at the leading edge internationally?), with a similarly high rating for the unit?s previous methodological support of clinical trials (including the IT and laboratory developments). The review panel recommended an increase in the CTSU?s core funding (which has now been endorsed by the MRC?s Health Services and Public Health Board) and suggested that additional support for our methodological work on trials should be obtained from the present MRC funding call. So, in order that the CTSU can extend its innovative methodological research related to clinical trials, as well as increase the level of support on trial methodology to external clinical researchers and other trials units, we are seeking support of additional posts for these areas of work. As in the past, the value of CTSU?s methodological work on clinical trials should be assessed in terms of the numbers of trials given such support that successfully answer important clinical questions, as well as our impact on improving systems for the recruitment and conduct of trials.
In December 2007, the CTSU had a quinquennial review by the MRC, and the review panel gave us the maximum overall rating of 6 out of 6 (?exceptional and at the leading edge internationally?), with a similarly high rating for the unit?s previous methodological support of clinical trials (including the IT and laboratory developments). The review panel recommended an increase in the CTSU?s core funding (which has now been endorsed by the MRC?s Health Services and Public Health Board) and suggested that additional support for our methodological work on trials should be obtained from the present MRC funding call. So, in order that the CTSU can extend its innovative methodological research related to clinical trials, as well as increase the level of support on trial methodology to external clinical researchers and other trials units, we are seeking support of additional posts for these areas of work. As in the past, the value of CTSU?s methodological work on clinical trials should be assessed in terms of the numbers of trials given such support that successfully answer important clinical questions, as well as our impact on improving systems for the recruitment and conduct of trials.
Organisations
People |
ORCID iD |
Rory Collins (Principal Investigator) |
Publications
Yang R
(2022)
Importance of healthy lifestyle factors and ideal cardiovascular health metrics for risk of heart failure in Chinese adults.
in International journal of epidemiology
Yang J
(2022)
Coarse Grain Consumption and Risk of Cardiometabolic Diseases: A Prospective Cohort Study of Chinese Adults.
in The Journal of nutrition
Study Of The Effectiveness Of Additional Reductions In Cholesterol And Homocysteine (SEARCH) Collaborative Group
(2010)
Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial.
in Lancet (London, England)
Sharp Collaborative Group
(2010)
Study of Heart and Renal Protection (SHARP): randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease.
in American heart journal
SEARCH Collaborative Group
(2008)
SLCO1B1 variants and statin-induced myopathy--a genomewide study.
in The New England journal of medicine
Parish S
(2022)
Effects of aspirin on dementia and cognitive function in diabetic patients: the ASCEND trial.
in European heart journal
Parish S
(2012)
Lipids and lipoproteins and risk of different vascular events in the MRC/BHF Heart Protection Study.
in Circulation
Nazarzadeh M
(2022)
Blood pressure-lowering treatment for prevention of major cardiovascular diseases in people with and without type 2 diabetes: an individual participant-level data meta-analysis.
in The lancet. Diabetes & endocrinology
Nag A
(2022)
Human genetics uncovers MAP3K15 as an obesity-independent therapeutic target for diabetes.
in Science advances
MRC/BHF Heart Protection Study Collaborative Group
(2009)
Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people.
in BMC clinical pharmacology
Mishra A
(2022)
Stroke genetics informs drug discovery and risk prediction across ancestries.
in Nature
Mentzer AJ
(2022)
Identification of host-pathogen-disease relationships using a scalable multiplex serology platform in UK Biobank.
in Nature communications
Kakkoura MG
(2022)
Dairy consumption and risks of total and site-specific cancers in Chinese adults: an 11-year prospective study of 0.5 million people.
in BMC medicine
HPS2-THRIVE Collaborative Group
(2013)
HPS2-THRIVE randomized placebo-controlled trial in 25 673 high-risk patients of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment.
in European heart journal
HPS2-THRIVE Collaborative Group
(2014)
Effects of extended-release niacin with laropiprant in high-risk patients.
in The New England journal of medicine
Hopewell JC
(2013)
Impact of common genetic variation on response to simvastatin therapy among 18 705 participants in the Heart Protection Study.
in European heart journal
Hopewell JC
(2011)
No impact of KIF6 genotype on vascular risk and statin response among 18,348 randomized patients in the heart protection study.
in Journal of the American College of Cardiology
Hopewell JC
(2011)
Lipoprotein(a) genetic variants associated with coronary and peripheral vascular disease but not with stroke risk in the Heart Protection Study.
in Circulation. Cardiovascular genetics
Herrington W
(2014)
The effect of lowering LDL cholesterol on vascular access patency: post hoc analysis of the Study of Heart and Renal Protection.
in Clinical journal of the American Society of Nephrology : CJASN
Heart Protection Study Collaborative Group
(2011)
C-reactive protein concentration and the vascular benefits of statin therapy: an analysis of 20,536 patients in the Heart Protection Study.
in Lancet (London, England)
Heart Protection Study Collaborative Group
(2011)
Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20,536 high-risk individuals: a randomised controlled trial.
in Lancet (London, England)
Haynes R
(2013)
Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol.
in Transplantation research
Haynes R
(2014)
Evaluating the contribution of the cause of kidney disease to prognosis in CKD: results from the Study of Heart and Renal Protection (SHARP).
in American journal of kidney diseases : the official journal of the National Kidney Foundation
Haynes R
(2014)
Effects of lowering LDL cholesterol on progression of kidney disease.
in Journal of the American Society of Nephrology : JASN
Emberson J
(2011)
C-reactive protein in the Heart Protection Study - Authors' reply
in The Lancet
Douaud G
(2022)
SARS-CoV-2 is associated with changes in brain structure in UK Biobank.
in Nature
Conroy MC
(2023)
UK Biobank: a globally important resource for cancer research.
in British journal of cancer
Clarke R
(2023)
Genetically Predicted Differences in Systolic Blood Pressure and Risk of Cardiovascular and Noncardiovascular Diseases: A Mendelian Randomization Study in Chinese Adults.
in Hypertension (Dallas, Tex. : 1979)
Chan KH
(2022)
Tobacco smoking and risks of more than 470 diseases in China: a prospective cohort study.
in The Lancet. Public health
Beševic J
(2022)
New Horizons: the value of UK Biobank to research on endocrine and metabolic disorders.
in The Journal of clinical endocrinology and metabolism
Baigent C
(2011)
Benefits of lowering cholesterol in chronic kidney disease - Authors' reply
in The Lancet
Baigent C
(2008)
Randomization is essential for progress in transplant medicine.
in Transplantation
Alegre-Díaz J
(2022)
Body mass index and COVID-19 mortality: prospective study of 120 000 Mexican adults.
in International journal of epidemiology
Akbari P
(2022)
Multiancestry exome sequencing reveals INHBE mutations associated with favorable fat distribution and protection from diabetes.
in Nature communications
Aguilar-Ramirez D
(2022)
Adiposity and NMR-measured lipid and metabolic biomarkers among 30,000 Mexican adults.
in Communications medicine
3C Study Collaborative Group
(2014)
Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial.
in Lancet (London, England)
3C Study Collaborative Group
(2014)
Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial.
in Lancet (London, England)