Trial Oversight

The Trial Steering Committee (TSC) is responsible for oversight of the trial in order to safeguard the interests of trial patients.

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Trial Oversight

The Trial Steering Committee (TSC) is responsible for oversight of the trial in order to safeguard the interests of trial patients.

Trial Oversight

The Trial Steering Committee (TSC) is responsible for oversight of the trial in order to safeguard the interests of trial patients. The TSC is comprised of a 75% majority of independent and lay members, as well as the Chief Investigator, representatives of Principal Investigators, a representative of the sponsor, the health economist and senior trial statistician. The committee provides advice to the Chief Investigator, UCL Comprehensive Clinical Trials Unit, the funder and sponsor on all aspects of the trial through its Independent Chair. The remit of the TSC is to oversee study conduct and advise the TMG.

The Trial Management Group (TMG) co-ordinates and strategically manages the trial.

The Independent Data Monitoring Committee (IDMC) is the only oversight body that has access to un-blinded accumulating comparative data. The IDMC is responsible for safeguarding the interests of trial patients, monitoring the accumulating data and making recommendations to the TSC on whether the trial should continue as planned.

Trial Management Group

Trial Steering Committee

Independant Data Monitoring Committee

Trial Management Group

The Trial Management Group (TMG) co-ordinates and strategically manages the trial.

Trial Management Group

The Trial Management Group (TMG) co-ordinates and strategically manages the trial.

The Trial Management Group is responsible for the day-to-day management of the trial, including monitoring of all aspects of the conduct and progress of the trial, ensuring that the protocol is adhered to and taking appropriate action to safeguard participants and the quality of the trial itself.

Featured

Mr Andrew Goldberg

Clinical Senior Lecturer in Trauma and Orthopaedics, Consultant Orthopaedic Foot and Ankle Surgeon

Mr Goldberg OBE qualified from St Mary’s Hospital Medical School (Imperial College London) in 1994. He is the Chief Investigator on the TARVA trial.

Dr Paul O'Donnell

Consultant Radiologist

Paul O’Donnell trained in musculoskeletal radiology both at Southampton University Hospitals and the Nuffield Orthopaedic Centre , and was a Consultant in Bristol before moving to the Royal National Orthopaedic Hospital in Stanmore.

Ms Iva Hauptmannova

Head of Research & Innovation Centre

Iva Hauptmannova graduated from University of Westminster in 2002, and received a Master’s degree from King’s College London in Medical Law and Ethics in 2003.

Ms Ekaterina Bordea

Fellow

Ekaterina completed an MSc in Economic Evaluation in Healthcare at City, University of London and holds a PhD in Economics from City, University of London.

Mrs Deidre Brooking

Clinical Research Coordinator

Deirdre is the TARVA Clinical Research Coordinator based at the Royal National Orthopaedic Hosptial. Deirdre has a BSc in Biochemistry from the University of Liverpool and an MSc in Biotechnology from the University of Reading.

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Mrs Karen Alligan

Clinical Nurse Specialist in Foot & Ankle Surgery

Karen is a Clinical Nurse Specialist at the world renowned, Royal National Orthopaedic Hospital NHS Trust in Stanmore.

Mrs Marion Cumbers

Patient Representative

Marion has a background in computer programming, and after the last of her four children went to school, in IT support in education at various levels. She was elected as a parent governor and was later an OFSTED lay inspector for 11 years.

Ms Liz Clark

Clinical Project Manager

Liz graduated from King’s College London with a BSc in Physiotherapy in 2008. Liz worked at the Medical Research Council Clinical Trials Unit at UCL from 2008 – 2016.

Mr James Blackstone

TARVA Trial Manager

James studied American History at the University of East Anglia, graduating with a BA in 2005 and an MA in 2007, before going on to conduct doctoral research at Clare College, Cambridge.

Miss Miriam Pollard

Clinical Data Manager

Miriam is the Data Manager for the TARVA trial. She graduated in 2016 from Bath University with a BSc in Psychology.

Dr Simon Skene

Principal Statistician

Simon Skene has more than 15 years’ experience, combining research and teaching in Statistics with the Open University and Birkbeck College. He holds a BSc in Mathematics and Statistics, MSc in Applied Statistics and Operational Research, and completed his PhD in Medical Statistics at LSHTM in 2008.

Mr Torsten Chandler

Health Economist

Torsten is the Trial Health Economist for the TARVA study. He holds a BA in Economics from the University of Exeter and an MA in Comparative Business Economics from UCL.

Trial Steering Committee

Trial Steering Committee

The Trial Steering Committee (TSC) is responsible for oversight of the trial in order to safeguard the interests of trial patients. The TSC is comprised of a 75% majority of independent and lay members, as well as the Chief Investigator, representatives of Principal Investigators, a representative of the sponsor, the health economist and senior trial statistician. The committee provides advice to the Chief Investigator, UCL Comprehensive Clinical Trials Unit, the funder and sponsor on all aspects of the trial through its Independent Chair. The remit of the TSC is to oversee study conduct and advise the TMG.

Featured

Mr Paul Cooke

Consultant Orthopaedic Foot & Ankle Surgeon

Trial Steering Committee

Mr Paul Cooke is an established international expert in foot and ankle surgery. He qualified in Sheffield in 1977, later gaining FRCS (London) in 1981, and MCh 1990.

Mr Andrew Goldberg

Clinical Senior Lecturer in Trauma and Orthopaedics, Consultant Orthopaedic Foot and Ankle Surgeon

Mr Goldberg OBE qualified from St Mary’s Hospital Medical School (Imperial College London) in 1994. He is the Chief Investigator on the TARVA trial.

Mrs Marion Cumbers

Patient Representative

Marion has a background in computer programming, and after the last of her four children went to school, in IT support in education at various levels. She was elected as a parent governor and was later an OFSTED lay inspector for 11 years.

Dr Stephen Brealey

Trial Coordinator for Methodology

Stephen has a background in Diagnostic Radiography and Health Services Research. His interests include the evaluation of diagnostic tests and interpretation of medical images.

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Mr Nick Welch

Patient and Public Rep.

Nick spent 35 years in the Pharmaceutical Industry working in sales and marketing throughout the EU before retiring in 2006. He joined the British Orthopaedic Association’s Patient Liaison Group in 2006 and has chaired it since 2012.

Ms Caroline Dore

Head of Statistics

Caroline is Head of Statistics at the UCL Clinical Trials Unit. Caroline graduated in Statistics from UCL in 1970 and has more than 40 years experience of collaboration in medical research.

Professor Alison McGregor

Professor of Musculoskeletal Biodynamics

Alison is chair of Musculoskeletal Biodynamics in the Department of Surgery and Cancer, where she manages the Human Performance Group.

Professor Amar Rangan

Professor of Orthopaedic Surgery

Amar is a Consultant Orthopaedic Surgeon in the Shoulder & Elbow Unit of The James Cook University Hospital.

Professor Damian Griffin

Consultant Orthopaedic Surgeon

Damian Griffin is the Professor of Trauma and Orthopaedic surgery at The University of Warwick. He trained at Cambridge, Oxford and in the United States and now has a clinical practice in hip surgery for young adults.

Professor Hamish Simpson

Professor of Orthopaedics & Trauma

Professor Simpson is the George Harrison Law Chair of Orthopaedics at the University of Edinburgh, and Editor-in-Chief of the Bone and Joint Research Journal.

Professor Marion Campbell

Director, Health Services Research Unit

Marion is the Director of the Health Services Research Unit at the University of Aberdeen where she has worked since 1993.

Professor Nachi Chockalingam

Professor of Clinical Biomechanics

Nachi has a doctoral thesis on gait and posture analysis of patients with scoliosis and is the Professor of Clinical Biomechanics at the Faculty of Health Sciences, University of Staffordshire.

Professor Steve Morris

Chair in Health Economics

Steve joined UCL in 2009 and is now the Chair of Health Economics. He has a BA in Economics and Philosophy from the University of Nottingham, an MSc in Health Economics from the University of York, and a PhD in Economics from City University London.

Mr James Blackstone

TARVA Trial Manager

James studied American History at the University of East Anglia, graduating with a BA in 2005 and an MA in 2007, before going on to conduct doctoral research at Clare College, Cambridge.

Mr Torsten Chandler

Health Economist

Torsten is the Trial Health Economist for the TARVA study. He holds a BA in Economics from the University of Exeter and an MA in Comparative Business Economics from UCL.

Independant Data Monitoring Committee

The IDMC is responsible for safeguarding the interests of trial patients, monitoring the accumulating data and making recommendations to the TSC on whether the trial should continue as planned.

Independant Data Monitoring Committee

The IDMC is responsible for safeguarding the interests of trial patients, monitoring the accumulating data and making recommendations to the TSC on whether the trial should continue as planned.

The Independent Data Monitoring Committee (IDMC) is the only oversight body that has access to un-blinded accumulating comparative data. The role of the IDMC is to assess at intervals, the progress of the trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop the trial.

Featured

Professor Justin Cobb

Professor of Orthopaedic Surgery

Justin graduated from Magdalen College Oxford in 1982. After 15 years as a consultant at UCLH, he joined Imperial as chair of orthopaedics in 2005. He is involved in the OsteoArthritis Centre, funded by an £11m grant from the Wellcome Trust and EPSRC.

Professor Linda Sharples

Professor in Statistics

Linda Sharples was appointed Professor of Statistics in the Clinical Trials Research Unit in September 2013. There she leads the Comprehensive Health Research Division which has a focus on musculoskeletal, cardiovascular, skin and dental trials.

Professor Mike Hurley

Professor of Rehabilitation Sciences

Professor Hurley is the research lead for the School of Rehabilitation Sciences. He qualified as a physiotherapist in 1985 and obtained his PhD in 1992.