Introduction to Trials Unit

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Funding Cancer Research UK, MRC Clinical Trials Unit at UCL, Canadian Cancer Trials Group.

Early Phase Trials Unit.

Patients were randomly assigned (1:1) to biomarker-guided recommendation on antibiotics (intervention group) or routine use of antibiotics (control group) using a web-based randomisation service hosted by Newcastle Clinical Trials Unit.

gov, the Clinical Trials Unit of the International Union Against Tuberculosis and Lung Disease, the UK Medical Research Council Clinical Trials Unit, and the Clinical Trials Registry India for ongoing trials.

Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT Helen Yates,1* Virginia Chiocchia,2 Louise Linsell,2 Nicolas Orsi,3 Edmund Juszczak,2 Kathryn Johnson,4 Philip Chetcuti,4 Claire Illingworth,5 Pollyanna Hardy,6 Vaneesha Monk,7 Simon Newell8† and Mark Turner9 1Department of Neonatal Medicine, Women and Children’s Hospital, Hull Royal Infirmary, Hull, UK 2NPEU Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK 3Women’s Health Research Group, Leeds Institute of Cancer and Pathology, St James’s University Hospital, Leeds, UK 4Leeds Neonatal Service, Leeds General Infirmary, Leeds, UK 5Patient and public involvement representative 6Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK 7Department of Paediatrics, University of Oxford, John Radcliffe Hospital, Oxford, UK 8Leeds Teaching Hospitals NHS Trust, Leeds, UK 9Neonatal Unit, Liverpool Women’s Hospital, Liverpool, UK *Corresponding author Helen.

We assessed an integrated, multi-pronged strategy for improving youth’s timely linkage to care carried out in eight adolescent medicine clinical trials units (AMTUs) in the USA.

Material and methods The software was installed in the pharmacy-based Clinical Trials Unit in July 2018.

SETTING Clinical Trials Units in St Olav's Hospital, Trondheim and Rikshospitalet, Oslo, Norway.

In brief, we conducted a survey of 38 United Kingdom–registered Clinical Trials Units, reviewed a cohort of 264 published trials, observed 8 third oversight committee meetings and interviewed 52 trialists.

The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).

He led a highly successful AIDS Clinical Trials Unit at the University of North Carolina and was a respected leader in this national consortium who gained international recognition and respect for his work.

Adopt Clinical Trials Units officially and contractually recognized would be essential to bring back our nation on the top of the world health systems ranking, but yet the Italian research-dedicated infrastructures continue to be a ghost reality, deeply characterized by a continuous professional turnover and by the lack of long-term prospects.

Abbreviations: SUDs: substance use disorders; STIs: sexually transmitted infections; CODs: co-occurring disorders; UEC-INPRFM: clinical trials unit in addiction and mental health-national institute of psychiatry ramón de la fuente muñiz.

TRoMbone aimed to recruit 50 men over a 12-month period and was co-ordinated by the Surgical Intervention Trials Unit at the University of Oxford.

12Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham, UK.

Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres.

Legal entity responsible for the study Medical Research Council-Clinical Trials Unit and University of Manchester.

Early Phase Clinical Trials Unit, Department of Oncology, University of Oxford, United Kingdom.

Outstanding Research Team Prize The prize was awarded to the team of the CHAPAS (Children with HIV in Africa – Pharmacokinetics and acceptability of simple antiretroviral regimens) studies, led by Professor Diana Gibb (MRC Clinical Trials Unit, United Kingdom).

Four main themes around trial set-up were identified from semi-structured interviews: the importance of communication and building relationships, the previous experience of the chief investigator and clinical trials units, a lack of resources and having the time and personnel required to produce trial documentation and to process trial approval requests.

She is an attending physician in the Cutaneous Lymphoma Clinic, Extracorporeal Photopheresis Program, and the Clinical Trials Unit where she participates in multicenter clinical trials for refractory CTCL.

FOCUS4 (colorectal cancer) and STAMPEDE (prostate cancer), run from the Medical Research Council Clinical Trials Unit (CTU) at UCL, are two leading UK examples of clinical trials implementing adaptive platform protocol designs.

The trials unit at University College London has been at the forefront of this work, with ground-breaking trials such as STAMPEDE and FOCUS4.

JOHN ALLOTEY, WOMEN’S HEALTH RESEARCH UNIT, BARTS AND THE LONDON SCHOOL OF MEDICINE AND DENTISTRY, QUEEN MARY UNIVERSITY OF LONDON, LONDON, UK, AND NADINE MARLIN, PRAGMATIC CLINICAL TRIALS UNIT, BARTS AND THE LONDON SCHOOL OF MEDICINE AND DENTISTRY, QUEEN MARY UNIVERSITY LONDON, LONDON, UK.

Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT Mark A Hull,1* Kirsty Sprange,2 Trish Hepburn,2 Wei Tan,2 Aisha Shafayat,2 Colin J Rees,3 Gayle Clifford,4 Richard F Logan,5 Paul M Loadman,6 Elizabeth A Williams,7 Diane Whitham2 and Alan A Montgomery2 on behalf of the seAFOod Collaborative Group 1Leeds Institute of Medical Research, University of Leeds, St James’s University Hospital, Leeds, UK 2Nottingham Clinical Trials Unit, Queen’s Medical Centre, School of Medicine, University of Nottingham, Nottingham, UK 3Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK 4South Tyneside District Hospital, South Tyneside NHS Foundation Trust, South Shields, UK 5Nottingham Digestive Diseases Centre, Queen’s Medical Centre, University of Nottingham, Nottingham, UK 6School of Pharmacy and Medical Sciences, Institute of Cancer Therapeutics, University of Bradford, Bradford, UK 7Department of Oncology & Metabolism, Human Nutrition Unit, The Medical School, University of Sheffield, Sheffield, UK *Corresponding author M.

Dormandy, who became a consultant vascular surgeon at St George’s Hospital in 1973, would later set up a clinical trials unit there for new treatments and comparisons of drug therapy.

SE1 0BW 7Clinical Trials Unit, Medical School, Warwick University Faculty of Health, Social Care and Education, Kingston University and St George’s, University of London, London SW17 0RE 827 Devonshire Way, Croydon, CR0 8BU.

Andrew D Duckworth, Margaret M McQueen, Christopher E Tuck, Jonathan H Tobias, Jeremy Mark Wilkinson, Leela C Biant, Elizabeth Claire Pulford, Stephen Aldridge, Claire Edwards, Chris P Roberts, Manoj Ramachandran, Andrew Richard McAndrew, Kenneth C K Cheng, Phillip Johnston, Nasir H Shah, Philip Mathew, John Harvie, Birgit C Hanusch, Ronnie Harkess, Aryelly Rodriguez, Gordon D Murray, and Stuart H Ralston Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK Edinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, Edinburgh, UK Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK Trauma and Orthopaedic Surgery, University of Manchester, Manchester, UK Oxford University Hospitals NHS Foundation Trust, Headington, UK The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK Norfolk and Norwich University Hospital Foundation Trust, Norwich, UK Ipswich Hospital NHS Trust, Ipswich, UK Royal London Hospital, Barts Health NHS Trust, London, UK Royal Berkshire Hospital Foundation Trust, Reading, UK NHS Ayrshire and Arran, Ayr, UK Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK Warrington and Halton Hospitals NHS Foundation Trust, Warrington, UK Queen’s Hospital, Romford, UK Raigmore Hospital, Inverness, UK South Tees, Hospitals NHS Foundation Trust, Middlesbrough, UK Centre for Genomic and Experimental Medicine, MRC Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK.

Methods The study was carried out at a single phase I clinical trials unit.

Methods: Masked 2 arm, parallel assignment, equivalence RCT (largest to date in screening) with independent trials unit monitoring in people with diabetes aged ≥12 years attending screening in a single English program.

Hillmen Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, United Kingdom; CR-UK Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, United Kingdom; Liverpool Clinical Laboratories, Haemato-Oncology Diagnostic Service, Liverpool, United Kingdom; Liverpool Clinical Laboratories, Department of Blood Sciences, Liverpool, United Kingdom; Department of Haematology, Kent & Canterbury Hospital, Canterbury, United Kingdom; Russells Hall Hospital, Haematology Unit, Dudley, United Kingdom; Department of Oncology, University of Oxford, Oxford, United Kingdom; Department of Haematology, Sandwell Hospital, Birmingham, United Kingdom; Department of Haematology, Maidstone Hospital, Maidstone, United Kingdom; Department of Haematology, University Hospital Southampton, Southampton, United Kingdom; Department of Haematology & Blood Transfusion, Southend Hospital, Southend, United Kingdom; Department of Haematology, Heartlands Hospital, Birmingham, United Kingdom; Department of Haematology, Medway Maritime Hospital, Gillingham, United Kingdom; Department of Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom; Department of Clinical Haematology, Royal United Hospital, Bath, United Kingdom; Department of Haematology, Colchester General Hospital, Colchester, United Kingdom; Oncology Unit, Torbay Hospital, Torquay, United Kingdom; Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.

Feller-Kopman Division of Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City, Utah; Division of Thoracic Surgery, Northwestern Memorial Hospital, Chicago, Illinois; Doctor Evidence LLC, Santa Monica, California; Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; Howard Hughes Medical Institute, University of California San Francisco, San Francisco, California; Children’s Hospital Los Angeles, Los Angeles, California; Department of Medicine and Lung Institute of Western Australia, University of Western Australia, Perth, Western Australia, Australia; Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom; Oxford Respiratory Trials Unity, University of Oxford, Oxford, United Kingdom; Department of Pulmonary, Critical Care, and Sleep Medicine, NYU Langone Medicine Center, New York, New York; Department of Pulmonary and Critical Care Medicine, Duke University School ofMedicine, Durham,North Carolina; Division of Pulmonary andCritical CareMedicine, University of Southern California, Los Angeles, California; and Pulmonary and Critical Care Division, The Johns Hopkins University School of Medicine, Baltimore, Maryland.

We analyzed the overall outcomes and survival of 91 patients enrolled onto one of 14 Phase I and I/II trials for hematological malignancies at a dedicated early phase trials unit within a tertiary hematology unit.

---------------------------------------------------------------------------------------------------------------Implications of Demographic Changes on Familial Care Resources -With illustrative application to Hebei province of China Zhenglian Wang, Xianling Zhang and Yi Zeng ---------------------------------------------------------------------------------------------------------------Applications of multi-state models in hematology: bridging the gap Liesbeth de Wreede (LUMC Department of Medical Statistics and Bioinformatics and DKMS, Clinical Trials Unit) In methodological papers on multi-state models in biostatistical journals, their use is often motivated by applications in the field of hematopoietic stem cell (or bone marrow) transplantation (SCT).

METHODS We did a 52-week, open-label, parallel-group, multicentre, superiority, randomised controlled trial at 15 primary care or hospital-based clinical trials units and primary care practices in New Zealand.

We reviewed these statistics at regular trials unit team meetings.

Systematic review and meta–analysis of randomised trials (RCTs) of surveillance of increasing intensity for recurrence of colorectal cancer was conducted in collaboration with Erasmus University Rotterdam, Cambridge MRC Biostatistics Unit, the Surgical and Interventional Trials Unit (UCL) A ‘Big data’ analysis was conducted to re–examine published NHS data The PulMiCC trial (Pulmonary Metastasectomy in Colorectal Cancer) is an RCT recruiting participants referred for consideration of lung metastasectomy into a registered cohort.

This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre - Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).

Methods Behaviorally infected youth living with HIV ages 13-24 (N = 822) from 14 sites within the Adolescent Medicine Trials Unit (AMTU) were included in the study.

Visually Impaired OLder people’s Exercise programme for falls prevenTion (VIOLET): a feasibility study Nicola Adams,1* Dawn Skelton,2 Cathy Bailey,1 Denise Howel,3 Dorothy Coe,1 Rosy Lampitt,4 Jennifer Wilkinson,4 Tony Fouweather,3 Lex de Jong,2 Sheena Gawler,1 Vincent Deary,1 Joanne Gray,1 Heather Waterman5 and Steve Parry6 1Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK 2Institute of Applied Health Research, School of Health and Life Sciences, Centre for Living, Glasgow Caledonian University, Glasgow, UK 3Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK 4Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK 5Healthcare Sciences, Cardiff University, Cardiff, UK 6Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, UK *Corresponding author nicola.

The trial is coordinated by the CRUK Southampton Clinical Trials Unit.

NADINE MARLIN, PRAGMATIC CLINICAL TRIALS UNIT, BARTS AND THE LONDON SCHOOL OF MEDICINE AND DENTISTRY, QUEEN MARY UNIVERSITY LONDON, LONDON, UK, AND JOHN ALLOTEY, WOMEN’S HEALTH RESEARCH UNIT, BARTS AND THE LONDON SCHOOL OF MEDICINE AND DENTISTRY, QUEEN MARY UNIVERSITY OF LONDON, LONDON, UK.

This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UK CRC-registered clinical trials unit in receipt of NIHR clinical trials unit support funding.

gov, the Clinical Trials Unit of the International Union Against Tuberculosis and Lung Disease, the UK Medical Research Council Clinical Trials Unit, and the Clinical Trials Registry India for ongoing trials.

FUNDING Cancer Research UK, The National Institute for Health Research Health Technology Assessment Programme, The MRC Clinical Trials Unit at UCL.

Cattolica del Sacro Cuore Italy * Andrew Copas, MRC Clinical Trials Unit at UCL United Kingdom of Great Britain and Northern Ireland Kishore Kuma Das, Gauhati Univ.

Legal entity responsible for the study Comprehensive Cancer Trials Unit, Department of Clinical Oncology, The Chinese University of Hong Kong.

The Dominantly Inherited Alzheimer Network (DIAN) Trials Unit (TU) secondary prevention trial, incorporating two treatment arms with the monoclonal antibodies solanezumab and gantenerumab that target amyloid-beta, in individuals from families with autosomal dominant AD (7) completed enrollment and randomization in 2015; analyses to determine whether cognitive benefit was achieved should begin before 2021.

As a consequence of the positive results, AstraZeneca was engaged with the Medical Research Council trials unit to discuss regulatory submission using ICON6 as the single pivotal trial.

Adopt Clinical Trials Units officially and contractually recognized would be essential to bring back our nation on the top of the world health systems ranking, but yet the Italian research-dedicated infrastructures continue to be a ghost reality, deeply characterized by a continuous professional turnover and by the lack of long-term prospects.

This study is being conducted by the Clinical Trials Unit at the University of Sheffield.

This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-based monitoring in pragmatic trials.

This article highlights some of the key barriers to achieving this and makes suggestions on how they can be addressed within clinical trials units registered with the UK Clinical Research Collaboration.

The aim of this UK Clinical Trials Unit (CTU) survey was to identify which digital recruitment and retention tools are being used to support RCTs, their benefits and success characteristics.