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, UK

4-5 October 2011

Concatenated PDF 12S1

Page 1 of 8

Invited speaker presentation

Adaptive designs: current status, future outlook

Andy Grieve

Trials 2011 12(Suppl 1):A1

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

Nigel Stallard

Trials 2011 12(Suppl 1):A2

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

Flexible trial design in practice – dropping and adding arms in STAMPEDE: a multi-arm multi-stage randomised controlled trial

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

Trials 2011 12(Suppl 1):A3

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

Optimal design for multi-arm multi-stage clinical trials

James MS Wason and Thomas Jaki

Trials 2011 12(Suppl 1):A4

Published on: 13 December 2011
- Full Text
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Poster presentation

Model selection and sample size adaptation: HYPAZ trial

Simon Bond, Adrian Mander, Duncan Jodrell and Joseph Cheryian

Trials 2011 12(Suppl 1):A5

Published on: 13 December 2011
- Full Text
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Poster presentation

How Cancer Research UK is adapting to adaptive designs

Julie Hearn, Nicola Keat, Kate Law and Rowena Sharpe

Trials 2011 12(Suppl 1):A6

Published on: 13 December 2011
- Full Text
- PDF
Poster presentation

The importance of planning for a seamless transition in an adaptive phase II randomised trial

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

Trials 2011 12(Suppl 1):A7

Published on: 13 December 2011
- Full Text
- PDF
Poster presentation

Software tools for implementing simulation studies in adaptive seamless designs: introducing R package ASD

Nick Parsons, Tim Friede, Susan Todd and Nigel Stallard

Trials 2011 12(Suppl 1):A8

Published on: 13 December 2011
- Full Text
- PDF
Invited speaker presentation

Adverse effects

Stephen JW Evans

Trials 2011 12(Suppl 1):A9

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report

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

Trials 2011 12(Suppl 1):A10

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

Anti-epileptic drug harms: issues for meta-analysis

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

Trials 2011 12(Suppl 1):A11

Published on: 13 December 2011
- Full Text
- PDF
Poster presentation

Adverse event reporting in randomised trials of neuropathic pain: challenges for clinical usefulness of safety data

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

Trials 2011 12(Suppl 1):A12

Published on: 13 December 2011
- Full Text
- PDF
Poster presentation

Documentation of adverse events in non-commercial trials of intravitreal injection of anti-VEGF drugs to treat wet age-related macular degeneration (AMD)

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

Trials 2011 12(Suppl 1):A13

Published on: 13 December 2011
- Full Text
- PDF
Invited speaker presentation

Using biomarkers prospectively in adaptive clinical trials

Donald A Berry

Trials 2011 12(Suppl 1):A14

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

Data modeling methods in clinical trials: experiences from the clinical trial methods in neurodegenerative diseases project

Athanasios Anastasiou, Emmanuel Ifeachor and John Zajicek

Trials 2011 12(Suppl 1):A15

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications

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

Trials 2011 12(Suppl 1):A16

Published on: 13 December 2011
- Full Text
- PDF
Oral presentation

Designing a preliminary adaptive study to inform a biomarker trial in Psoriasis

Andrew T Prevost and Jack Bowden

Trials 2011 12(Suppl 1):A17

Published on: 13 December 2011
- Full Text
- PDF
Poster presentation

Selection of subjects for clinical trials in Alzheimer’s disease and mild cognitive impairment with machine learning analysis of MRI and CSF biomarkers

Javier Escudero, John P Zajicek and Emmanuel Ifeachor

Trials 2011 12(Suppl 1):A18

Published on: 13 December 2011
- Full Text
- PDF
Poster presentation

Comparing diagnostic tests and biomarkers: trials in people with discordant test results

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

Trials 2011 12(Suppl 1):A19

Published on: 13 December 2011
- Full Text
- PDF
Poster presentation

Choice of transformation for modelling non-linear continuous biomarkers

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

Trials 2011 12(Suppl 1):A20

Published on: 13 December 2011
- Full Text
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Page 1 of 8

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Trials

Clinical Trials Methodology Conference 2011

Meeting abstracts

Adaptive designs: current status, future outlook

An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

Flexible trial design in practice – dropping and adding arms in STAMPEDE: a multi-arm multi-stage randomised controlled trial

Optimal design for multi-arm multi-stage clinical trials

Model selection and sample size adaptation: HYPAZ trial

How Cancer Research UK is adapting to adaptive designs

The importance of planning for a seamless transition in an adaptive phase II randomised trial

Software tools for implementing simulation studies in adaptive seamless designs: introducing R package ASD

Adverse effects

Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report

Anti-epileptic drug harms: issues for meta-analysis

Adverse event reporting in randomised trials of neuropathic pain: challenges for clinical usefulness of safety data

Documentation of adverse events in non-commercial trials of intravitreal injection of anti-VEGF drugs to treat wet age-related macular degeneration (AMD)

Using biomarkers prospectively in adaptive clinical trials

Data modeling methods in clinical trials: experiences from the clinical trial methods in neurodegenerative diseases project

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications

Designing a preliminary adaptive study to inform a biomarker trial in Psoriasis

Selection of subjects for clinical trials in Alzheimer’s disease and mild cognitive impairment with machine learning analysis of MRI and CSF biomarkers

Comparing diagnostic tests and biomarkers: trials in people with discordant test results

Choice of transformation for modelling non-linear continuous biomarkers

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