Volume 12 Supplement 1

Clinical Trials Methodology Conference 2011

Meeting abstracts

Edited by Stephanie McAvoy and Emily Crowe

This conference was sponsored by the Network of Hubs for Trials Methodology Research

Clinical Trials Methodology Conference 2011. Go to conference site.

Bristol, UK4-5 October 2011

Concatenated PDF 12S1

Page 1 of 4

Adaptive designs: current status, future outlook

Authors: Andy Grieve

Citation: Trials 2011 12(Suppl 1):A1

Content type: Invited speaker presentation Published on: 13 December 2011
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An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

Authors: Nigel Stallard

Citation: Trials 2011 12(Suppl 1):A2

Content type: Oral presentation Published on: 13 December 2011
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Flexible trial design in practice – dropping and adding arms in STAMPEDE: a multi-arm multi-stage randomised controlled trial

Authors: Matthew R Sydes, Nicholas D James, Malcolm D Mason, Noel W Clarke, Claire Amos, John Anderson, Johann de Bono, David P Dearnaley, John Dwyer, Gordana Jovic, Alastair Ritchie, Martin Russell, Karen Sanders, George Thalmann and Mahesh KB Parmar

Citation: Trials 2011 12(Suppl 1):A3

Content type: Oral presentation Published on: 13 December 2011
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Optimal design for multi-arm multi-stage clinical trials

Authors: James MS Wason and Thomas Jaki

Citation: Trials 2011 12(Suppl 1):A4

Content type: Oral presentation Published on: 13 December 2011
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Model selection and sample size adaptation: HYPAZ trial

Authors: Simon Bond, Adrian Mander, Duncan Jodrell and Joseph Cheryian

Citation: Trials 2011 12(Suppl 1):A5

Content type: Poster presentation Published on: 13 December 2011
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How Cancer Research UK is adapting to adaptive designs

Authors: Julie Hearn, Nicola Keat, Kate Law and Rowena Sharpe

Citation: Trials 2011 12(Suppl 1):A6

Content type: Poster presentation Published on: 13 December 2011
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The importance of planning for a seamless transition in an adaptive phase II randomised trial

Authors: Andrea Marshall, Janet A Dunn, Julie Fletcher, Helen B Higgins and Christopher J Poole

Citation: Trials 2011 12(Suppl 1):A7

Content type: Poster presentation Published on: 13 December 2011
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Software tools for implementing simulation studies in adaptive seamless designs: introducing R package ASD

Authors: Nick Parsons, Tim Friede, Susan Todd and Nigel Stallard

Citation: Trials 2011 12(Suppl 1):A8

Content type: Poster presentation Published on: 13 December 2011
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Adverse effects

Authors: Stephen JW Evans

Citation: Trials 2011 12(Suppl 1):A9

Content type: Invited speaker presentation Published on: 13 December 2011
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Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report

Authors: Elizabeth N Allen, Karen I Barnes, Adiel Mushi, Isolide Massawe, Sarah G Staedke, Ushma Mehta, Lasse S Vestergaard, Martha M Lemnge and Clare I Chandler

Citation: Trials 2011 12(Suppl 1):A10

Content type: Oral presentation Published on: 13 December 2011
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Anti-epileptic drug harms: issues for meta-analysis

Authors: Catrin Tudur Smith, Arif Shukralla, Sarah Donegan, Karla Hemming, Graham A Powell, Paula Williamson and Anthony Marson

Citation: Trials 2011 12(Suppl 1):A11

Content type: Oral presentation Published on: 13 December 2011
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Adverse event reporting in randomised trials of neuropathic pain: challenges for clinical usefulness of safety data

Authors: Victoria R Cornelius, Odile Sauzet, Salma Ayis, Joy Ross, Paul Farquhar-Smith, Ruth A Branford, John E Williams and Janet L Peacock

Citation: Trials 2011 12(Suppl 1):A12

Content type: Poster presentation Published on: 13 December 2011
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Documentation of adverse events in non-commercial trials of intravitreal injection of anti-VEGF drugs to treat wet age-related macular degeneration (AMD)

Authors: Barnaby C Reeves, Wendy Underwood, Heike Cappel-Porter, Sarah Baos, Chris A Rogers, Michael Arnott, Simon P Harding, Usha Chakravarthy and Alex E Foss

Citation: Trials 2011 12(Suppl 1):A13

Content type: Poster presentation Published on: 13 December 2011
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Using biomarkers prospectively in adaptive clinical trials

Authors: Donald A Berry

Citation: Trials 2011 12(Suppl 1):A14

Content type: Invited speaker presentation Published on: 13 December 2011
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Data modeling methods in clinical trials: experiences from the clinical trial methods in neurodegenerative diseases project

Authors: Athanasios Anastasiou, Emmanuel Ifeachor and John Zajicek

Citation: Trials 2011 12(Suppl 1):A15

Content type: Oral presentation Published on: 13 December 2011
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Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications

Authors: Kinga Malottki, Mousumi Biswas, Jon Deeks, Richard Riley, Charles Craddock and Lucinda Billingham

Citation: Trials 2011 12(Suppl 1):A16

Content type: Oral presentation Published on: 13 December 2011
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Designing a preliminary adaptive study to inform a biomarker trial in Psoriasis

Authors: Andrew T Prevost and Jack Bowden

Citation: Trials 2011 12(Suppl 1):A17

Content type: Oral presentation Published on: 13 December 2011
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Selection of subjects for clinical trials in Alzheimer’s disease and mild cognitive impairment with machine learning analysis of MRI and CSF biomarkers

Authors: Javier Escudero, John P Zajicek and Emmanuel Ifeachor

Citation: Trials 2011 12(Suppl 1):A18

Content type: Poster presentation Published on: 13 December 2011
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Comparing diagnostic tests and biomarkers: trials in people with discordant test results

Authors: Richard Hooper, Karla Díaz-Ordaz, Andrea Takeda and Khalid Khan

Citation: Trials 2011 12(Suppl 1):A19

Content type: Poster presentation Published on: 13 December 2011
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Choice of transformation for modelling non-linear continuous biomarkers

Authors: Deborah D Stocken, Lucinda J Billingham, Philip J Johnson and Nick Freemantle

Citation: Trials 2011 12(Suppl 1):A20

Content type: Poster presentation Published on: 13 December 2011
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Statistical issues in the analysis of non-pharmacological therapy trials with clustering by care-provider or therapy group

Authors: Chris Roberts

Citation: Trials 2011 12(Suppl 1):A21

Content type: Invited speaker presentation Published on: 13 December 2011
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Stratified randomisation: a hidden form of clustering?

Authors: Brennan C Kahan and Tim P Morris

Citation: Trials 2011 12(Suppl 1):A22

Content type: Oral presentation Published on: 13 December 2011
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A review of methodology for sample size calculations in cluster randomised trials

Authors: Clare Rutterford, Sandra Eldridge and Andrew Copas

Citation: Trials 2011 12(Suppl 1):A23

Content type: Oral presentation Published on: 13 December 2011
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Clustering in surgical trials – database of intra-cluster correlations

Authors: Jonathan A Cook, Thomas Bruckner, Graeme S MacLennan and Christoph M Seiler

Citation: Trials 2011 12(Suppl 1):A24

Content type: Poster presentation Published on: 13 December 2011
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Sample size in cluster randomised trials with unequal clusters

Authors: Ivana Holloway and Amanda Farrin

Citation: Trials 2011 12(Suppl 1):A25

Content type: Poster presentation Published on: 13 December 2011
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Sample size determination through power simulation; practical lessons from a stepped wedge cluster randomised trial (SW CRT)

Authors: Munyaradzi Dimairo, Mike Bradburn and Stephen J Walters

Citation: Trials 2011 12(Suppl 1):A26

Content type: Poster presentation Published on: 13 December 2011
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Coping with clustering in sample size calculations

Authors: Rebecca Playle, Mark Kelly, Robert Newcombe and Kerry Hood

Citation: Trials 2011 12(Suppl 1):A27

Content type: Poster presentation Published on: 13 December 2011
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Equivalence and non inferiority trials

Authors: Ralph B D’Agostino Sr

Citation: Trials 2011 12(Suppl 1):A28

Content type: Invited speaker presentation Published on: 13 December 2011
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Is there a danger of “biocreep” with non-inferiority trials?

Authors: Primrose Beryl and Werner Vach

Citation: Trials 2011 12(Suppl 1):A29

Content type: Oral presentation Published on: 13 December 2011
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Choice of randomisation time-point in non-inferiority studies of reduced treatment duration: experience from the SCOT study

Authors: Jim Paul, Tim Iveson, Rachel Midgley, Andrea Harkin, Michelle Masterton, Laura Alexander and Jim Cassidy

Citation: Trials 2011 12(Suppl 1):A30

Content type: Oral presentation Published on: 13 December 2011
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The evolution of and challenges in defining the clinical endpoint in tuberculosis treatment trials with non-inferiority designs

Authors: Patrick PJ Phillips, Angela Crook and Andrew J Nunn

Citation: Trials 2011 12(Suppl 1):A31

Content type: Oral presentation Published on: 13 December 2011
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Challenges of defining a non-inferiority margin: a case study of non-inferiority randomized controlled trials of oral anti-thrombolytic agents for prophylaxis of venous thromboembolic events after orthopedic surgery

Authors: Grace Wangge, Olaf H Klungel, Kit CB Roes, Antonius de Boer, Arno W Hoes and Mirjam J Knol

Citation: Trials 2011 12(Suppl 1):A32

Content type: Oral presentation Published on: 13 December 2011
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The STAR trial: can quality of life benefit offset any survival detriment?

Authors: Fiona Collinson, Janet Brown, Christopher McCabe, Julia Brown, Sandy Tubeuf, Barbara Potrata, Jenny Hewison, Ines Rombach, Peter Selby, Catherine Olivier, Helen Howard and Walter Gregory

Citation: Trials 2011 12(Suppl 1):A33

Content type: Poster presentation Published on: 13 December 2011
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The ABC of non-inferiority margin setting: an investigation of approaches

Authors: Steven A Julious

Citation: Trials 2011 12(Suppl 1):A34

Content type: Poster presentation Published on: 13 December 2011
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Streamlining regulation of clinical trials – update on the Academy of Medical Sciences review and government’s response

Authors: Gary A Ford

Citation: Trials 2011 12(Suppl 1):A35

Content type: Invited speaker presentation Published on: 13 December 2011
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Interim reports for data monitoring committee review vs final reports for regulatory filing

Authors: KyungMann Kim

Citation: Trials 2011 12(Suppl 1):A36

Content type: Oral presentation Published on: 13 December 2011
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A practical solution to ‘Continuing Care Site’ issues in neonatal clinical trials – a pragmatic approach to regulatory and research governance review

Authors: Kayleigh Morgan, Ed Juszczak and Ursula Bowler

Citation: Trials 2011 12(Suppl 1):A37

Content type: Oral presentation Published on: 13 December 2011
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Exploring the ethical and practical challenges of conducting clinical trials in care home settings

Authors: Fiona Wood, Hayley Prout, Arun Acharjya, Jacqueline Nuttall, Kerry Hood and Christopher Butler

Citation: Trials 2011 12(Suppl 1):A38

Content type: Oral presentation Published on: 13 December 2011
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Risk-adapted approaches to the management of clinical trials: guidance from the Department of Health (DH)/Medical Research Council(MRC)/Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Trials Working Group

Authors: Sarah Meredith, Martyn Ward, Gillian Booth, Andrew Fisher, Carrol Gamble, Heather House and Martin Landray

Citation: Trials 2011 12(Suppl 1):A39

Content type: Poster presentation Published on: 13 December 2011
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Using economic modelling to contribute to the prioritisation and design and clinical trials: ready for prime time

Authors: Mark Sculpher

Citation: Trials 2011 12(Suppl 1):A40

Content type: Invited speaker presentation Published on: 13 December 2011
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Analysis of adverse events and quality of life data for an economic evaluation of adjuvant chemotherapy in colorectal cancer: when can we stop collecting?

Authors: Kathleen A Boyd, Andrew H Briggs, Jim Paul, Tim Iveson, Rachel Midgely, Andrea Harkin, Gaynor Bates, Laura Alexander and Jim Cassidy

Citation: Trials 2011 12(Suppl 1):A41

Content type: Oral presentation Published on: 13 December 2011
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What is the value of collecting detailed costing data in clinical trials?

Authors: Helen Dakin, Giselle Abangma and Sarah Wordsworth

Citation: Trials 2011 12(Suppl 1):A42

Content type: Oral presentation Published on: 13 December 2011
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Bayesian analysis of trial-based cost-effectiveness in the presence of missing data: effects of including covariates on efficiency of estimation in the ASTER trial

Authors: Linda Sharples, Christopher Jackson, Ella Wheaton and Robert Rintoul

Citation: Trials 2011 12(Suppl 1):A43

Content type: Oral presentation Published on: 13 December 2011
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HERALD (Health Economics using Routine Anonymised Linked Data)

Authors: Muhammad J Husain, Sinead Brophy, Steven Macey, Leila M Pinder, Mark D Atkinson, Roxanne Cooksey, Ceri J Phillips and Stefan Siebert

Citation: Trials 2011 12(Suppl 1):A44

Content type: Poster presentation Published on: 13 December 2011
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Estimation of cost-effectiveness in randomised controlled trials when not all participants allocated to active intervention receive it

Authors: Chris Metcalfe

Citation: Trials 2011 12(Suppl 1):A45

Content type: Poster presentation Published on: 13 December 2011
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How best to handle the evidence in a cost-effectiveness analysis of TAVI in the UK

Authors: Aileen Murphy, Elizabeth Fenwick, Andrew Briggs and Matthew Neilson

Citation: Trials 2011 12(Suppl 1):A46

Content type: Poster presentation Published on: 13 December 2011
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The influence of CONSORT on the quality of reporting of randomised controlled trials: an updated review

Authors: Lucy Turner, David Moher, Larissa Shamseer, Laura Weeks, Jodi Peters, Amy Plint, Douglas G Altman and Kenneth F Schulz

Citation: Trials 2011 12(Suppl 1):A47

Content type: Oral presentation Published on: 13 December 2011
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What can available randomised controlled trials evaluating monitoring strategies tell us about the design and analysis of future trials?

Authors: Jacqueline Dinnes, Jenny Hewison, Doug Altman and Jon Deeks

Citation: Trials 2011 12(Suppl 1):A48

Content type: Oral presentation Published on: 13 December 2011
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Cochrane systematic reviews as a source of information for practice and trials

Authors: Mike Clarke, Thomas T Clarke and Lorcan Clarke

Citation: Trials 2011 12(Suppl 1):A49

Content type: Oral presentation Published on: 13 December 2011
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Biases in clinical trials with sequential monitoring

Authors: Manjula Schou and Ian C Marschner

Citation: Trials 2011 12(Suppl 1):A50

Content type: Oral presentation Published on: 13 December 2011
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