Volume 12, supplement issue 1, December 2011

Clinical Trials Methodology Conference 2011

Issue editor

McAvoy Stephanie

151 articles in this issue

Adaptive designs: current status, future outlook

Authors
- Andy Grieve
- Content type: Invited speaker presentation
- Open Access
- Published: 13 December 2011
- Article: A1
An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

Authors
- Nigel Stallard
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A2
Flexible trial design in practice – dropping and adding arms in STAMPEDE: a multi-arm multi-stage randomised controlled trial

Authors (first, second and last of 15)
- Matthew R Sydes
- Nicholas D James
- Mahesh KB Parmar
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A3
Optimal design for multi-arm multi-stage clinical trials

Authors
- James MS Wason
- Thomas Jaki
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A4
Model selection and sample size adaptation: HYPAZ trial

Authors (first, second and last of 4)
- Simon Bond
- Adrian Mander
- Joseph Cheryian
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A5
How Cancer Research UK is adapting to adaptive designs

Authors (first, second and last of 4)
- Julie Hearn
- Nicola Keat
- Rowena Sharpe
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A6
The importance of planning for a seamless transition in an adaptive phase II randomised trial

Authors (first, second and last of 5)
- Andrea Marshall
- Janet A Dunn
- Christopher J Poole
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A7
Software tools for implementing simulation studies in adaptive seamless designs: introducing R package ASD

Authors (first, second and last of 4)
- Nick Parsons
- Tim Friede
- Nigel Stallard
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A8
Adverse effects

Authors
- Stephen JW Evans
- Content type: Invited speaker presentation
- Open Access
- Published: 13 December 2011
- Article: A9
Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report

Authors (first, second and last of 9)
- Elizabeth N Allen
- Karen I Barnes
- Clare I Chandler
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A10
Anti-epileptic drug harms: issues for meta-analysis

Authors (first, second and last of 7)
- Catrin Tudur Smith
- Arif Shukralla
- Anthony Marson
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A11
Adverse event reporting in randomised trials of neuropathic pain: challenges for clinical usefulness of safety data

Authors (first, second and last of 8)
- Victoria R Cornelius
- Odile Sauzet
- Janet L Peacock
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A12
Documentation of adverse events in non-commercial trials of intravitreal injection of anti-VEGF drugs to treat wet age-related macular degeneration (AMD)

Authors (first, second and last of 9)
- Barnaby C Reeves
- Wendy Underwood
- Alex E Foss
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A13
Using biomarkers prospectively in adaptive clinical trials

Authors
- Donald A Berry
- Content type: Invited speaker presentation
- Open Access
- Published: 13 December 2011
- Article: A14
Data modeling methods in clinical trials: experiences from the clinical trial methods in neurodegenerative diseases project

Authors
- Athanasios Anastasiou
- Emmanuel Ifeachor
- John Zajicek
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A15
Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications

Authors (first, second and last of 6)
- Kinga Malottki
- Mousumi Biswas
- Lucinda Billingham
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A16
Designing a preliminary adaptive study to inform a biomarker trial in Psoriasis

Authors
- Andrew T Prevost
- Jack Bowden
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A17
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
- Emmanuel Ifeachor
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A18
Comparing diagnostic tests and biomarkers: trials in people with discordant test results

Authors (first, second and last of 4)
- Richard Hooper
- Karla Díaz-Ordaz
- Khalid Khan
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A19
Choice of transformation for modelling non-linear continuous biomarkers

Authors (first, second and last of 4)
- Deborah D Stocken
- Lucinda J Billingham
- Nick Freemantle
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A20
Statistical issues in the analysis of non-pharmacological therapy trials with clustering by care-provider or therapy group

Authors
- Chris Roberts
- Content type: Invited speaker presentation
- Open Access
- Published: 13 December 2011
- Article: A21
Stratified randomisation: a hidden form of clustering?

Authors
- Brennan C Kahan
- Tim P Morris
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A22
A review of methodology for sample size calculations in cluster randomised trials

Authors
- Clare Rutterford
- Sandra Eldridge
- Andrew Copas
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A23
Clustering in surgical trials – database of intra-cluster correlations

Authors (first, second and last of 4)
- Jonathan A Cook
- Thomas Bruckner
- Christoph M Seiler
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A24
Sample size in cluster randomised trials with unequal clusters

Authors
- Ivana Holloway
- Amanda Farrin
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A25
Sample size determination through power simulation; practical lessons from a stepped wedge cluster randomised trial (SW CRT)

Authors
- Munyaradzi Dimairo
- Mike Bradburn
- Stephen J Walters
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A26
Coping with clustering in sample size calculations

Authors (first, second and last of 4)
- Rebecca Playle
- Mark Kelly
- Kerry Hood
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A27
Equivalence and non inferiority trials

Authors
- Ralph B D’Agostino Sr
- Content type: Invited speaker presentation
- Open Access
- Published: 13 December 2011
- Article: A28
Is there a danger of “biocreep” with non-inferiority trials?

Authors
- Primrose Beryl
- Werner Vach
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A29
Choice of randomisation time-point in non-inferiority studies of reduced treatment duration: experience from the SCOT study

Authors (first, second and last of 7)
- Jim Paul
- Tim Iveson
- Jim Cassidy
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A30
The evolution of and challenges in defining the clinical endpoint in tuberculosis treatment trials with non-inferiority designs

Authors
- Patrick PJ Phillips
- Angela Crook
- Andrew J Nunn
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A31
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 (first, second and last of 6)
- Grace Wangge
- Olaf H Klungel
- Mirjam J Knol
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A32
The STAR trial: can quality of life benefit offset any survival detriment?

Authors (first, second and last of 12)
- Fiona Collinson
- Janet Brown
- Walter Gregory
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A33
The ABC of non-inferiority margin setting: an investigation of approaches

Authors
- Steven A Julious
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A34
Streamlining regulation of clinical trials – update on the Academy of Medical Sciences review and government’s response

Authors
- Gary A Ford
- Content type: Invited speaker presentation
- Open Access
- Published: 13 December 2011
- Article: A35
Interim reports for data monitoring committee review vs final reports for regulatory filing

Authors
- KyungMann Kim
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A36
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
- Ursula Bowler
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A37
Exploring the ethical and practical challenges of conducting clinical trials in care home settings

Authors (first, second and last of 6)
- Fiona Wood
- Hayley Prout
- Christopher Butler
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A38
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 (first, second and last of 7)
- Sarah Meredith
- Martyn Ward
- Martin Landray
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A39
Using economic modelling to contribute to the prioritisation and design and clinical trials: ready for prime time

Authors
- Mark Sculpher
- Content type: Invited speaker presentation
- Open Access
- Published: 13 December 2011
- Article: A40
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 (first, second and last of 9)
- Kathleen A Boyd
- Andrew H Briggs
- Jim Cassidy
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A41
What is the value of collecting detailed costing data in clinical trials?

Authors
- Helen Dakin
- Giselle Abangma
- Sarah Wordsworth
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A42
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 (first, second and last of 4)
- Linda Sharples
- Christopher Jackson
- Robert Rintoul
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A43
HERALD (Health Economics using Routine Anonymised Linked Data)

Authors (first, second and last of 8)
- Muhammad J Husain
- Sinead Brophy
- Stefan Siebert
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A44
Estimation of cost-effectiveness in randomised controlled trials when not all participants allocated to active intervention receive it

Authors
- Chris Metcalfe
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A45
How best to handle the evidence in a cost-effectiveness analysis of TAVI in the UK

Authors (first, second and last of 4)
- Aileen Murphy
- Elizabeth Fenwick
- Matthew Neilson
- Content type: Poster presentation
- Open Access
- Published: 13 December 2011
- Article: A46
The influence of CONSORT on the quality of reporting of randomised controlled trials: an updated review

Authors (first, second and last of 8)
- Lucy Turner
- David Moher
- Kenneth F Schulz
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A47
What can available randomised controlled trials evaluating monitoring strategies tell us about the design and analysis of future trials?

Authors (first, second and last of 4)
- Jacqueline Dinnes
- Jenny Hewison
- Jon Deeks
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A48
Cochrane systematic reviews as a source of information for practice and trials

Authors
- Mike Clarke
- Thomas T Clarke
- Lorcan Clarke
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A49
Biases in clinical trials with sequential monitoring

Authors
- Manjula Schou
- Ian C Marschner
- Content type: Oral presentation
- Open Access
- Published: 13 December 2011
- Article: A50

Volume 12, supplement issue 1, December 2011

Clinical Trials Methodology Conference 2011

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