Trials

The madness of HIV prevention trials

S McCormack

Discussion session: biomarker trials

Science in a crisis: conducting clinical trials in an emergency

P Horby

Good practice principles for sharing individual participant data from publicly funded clinical trials

Catrin Tudur Smith, Carolyn Hopkins, Matt Sydes, Kerry Woolfall, Mike Clarke, Gordon Murray, Paula Williamson

Reading or listening to review summaries - which method will produce greater understanding of the key outcomes in a cochrane review?

Lisa Maguire, Mike Clarke, Mark Tully

How are systematic reviews used in the planning and design of health technology assessment funded trials?

Sheetal Bhurke, Andrew Cook, Anna Tallant, Amanda Young, Elaine Williams, James Raftery

The value of evidence synthesis in randomised controlled trial (RCT) design, conduct and analysis: MRC clinical trials unit (CTU) at UCL experience

Jayne F Tierney, Sarah Burdett, Claire Vale, Larysa Rydzewska, Matthew R Sydes, Ruth E Langley, Richard S Kaplan, Mahesh KB Parmar

Methods for selecting health concepts and domains from in-depth qualitative interviews for the development of patient reported outcome measures (PROMS): a case study

Jane Blazeby, Leila Rooshenas, Rhiannon Macefield, Daisy Townsend, Tom Milne

Development of a single, practical measure of surgical site infection (SSI) for patient self-report and observer completion: a novel method of questionnaire design

Rhiannon Macefield, Alex Nicholson, Tom Milne, Thomas Pinkney, Melanie Calvert, Kerry Avery, Barnaby Reeves, Jane Blazeby

Understanding patterns of adverse events after surgery and their impact on recovery

Rachel L Nash, Barnaby C Reeves, Gianni D Angelini, Chris A Rogers

Ongoing validation of health-related quality of life instruments

Kim Cocks, Puvan Tharmanathan

Trials within trials of interventions to improve recruitment and retention: the experience of York Trials Unit

David Torgerson, Caroline Fairhurst

Assessing the effectiveness of a ‘site visit’ on recruitment rates in a multicentre randomised trial: SWAT-1

Valerie Smith, Mike Clarke, Cecily Begley, Declan Devane

Scoop pen sub-study-a ‘trial within a trial’ of enclosing a pen in questionnaire mailings to increase response rate

Caroline Fairhurst, Kerry Bell, Laura Clark, Natasha Mitchell, Elizabeth Lenaghan, Jeanette Blacklock, Lee Shepstone, David Torgerson

Developing guidelines for reporting embedded recruitment trials

Vichithranie W Madurasinghe, Sandra Eldridge, Gordon Forbes

Dose transition pathways: a design, analysis and operational tool for dose-finding trials using model-based designs

Christina Yap, Lucinda Billingham, Charles Craddock, John O'Quigley

Conducting a randomised trial during an influenza pandemic: an example of a trial set up and ‘hibernated’ ready to activate and recruit within 4 weeks

Clare Brittain, Garry Meakin, Margo Childs, Lelia Duley, Wei Shen Lim

Using the UK renal registry for a clinical trial in dialysis patients: the example of SIMPLIFIED

Simon Bond, Rupert Payne, Edward Wilson, Afzal Chowdry, Fergus Caskey, David Wheeler, Thomas Hiemstra

The design of a multi-arm multi-stage (MAMS) phase III randomised controlled trial comparing alternative regimens for escalating (COMPARE) treatment of intermediate and high-risk oropharyngeal cancer with reflections on the complications of introducing a new experimental ARM

Piers Gaunt, Hisham Mehanna, Christina Yap

Progression from an internal pilot of a main trial including adaptation from a two to three group study - straightforward to do?

Danielle Edwards, Graziella Mazza, Rachael Heys, Caroline Wilson, Jane Blazeby, Chris Rogers

Adapting a trial design based on feasibility of recruitment where several treatment groups are possible and the outcome is long-term: pre-empt flexible-entry internal pilot study

Lee Middleton, Jane Daniels, Kostas Tryposkiadis, Laura Gennard, Lisa Leighton, Siladitya Bhattacharya

The use of early decision modelling and value of information analysis in an adaptive trial design: results from the OPTIMA preliminary study

Peter Hall, Alison Smith, Claire Hulme, Armando Vargas-Palacios, Janet Dunn, Andrea Marshall, John Bartlett, Rob Stein, David Cameron, Christopher McCabe

Meandering journey towards routine trial adaptation: survey results on barriers to use of adaptive designs in confirmatory trials

Munyaradzi Dimairo, Steven Julious, Susan Todd, Jonathan Nicholl

What does a good RCT recruitment consultation look like? A new simple six-step model to promote information sharing and recruitment to RCTs

Alba Realpe, Ann Adams, Peter Wall, Damian Griffin, Jenny L Donovan

Using vignettes to understand variations in patient screening and recruitment

Elaine McColl, Paul Hilton, Cath Brennand

Exploring challenges of RCTs in the emergency and critical care setting

Paul Mouncey, Sarah Power, David Harrison, Sheila Harvey, Kathryn Rowan

Use of home visits increases data completion and retention in studies involving family members

Katie Biggs, Cindy Cooper

Can using a resource use log in an economic evaluation alongside a randomised controlled trial reduce the amount of recall bias?

Sian Noble, Isobel Tudge, Vikki Wylde, Erik Lenguerrand, Elsa Marques

Identification of items for a standardised resource-use measure: review of current instruments

Joanna Thorn, Colin Ridyard, Ruth Riley, Sara Brookes, Dyfrig Hughes, Sarah Wordsworth, Sian Noble, William Hollingworth

Modelling cost-effectiveness and value of information in clinical trials to inform stop go decisions: results from the arctic study

Alison Smith, Peter Hall, John O'Dwyer, Claire Hulme, Dena Cohen, Walter Gregory

The use of hospital episode statistics (HES) records alongside clinical trials

Belen Corbacho, Kerry Bell, Rita Santos, David Torgerson

Researchers' experiences of optimising complex health interventions before full-scale RCTs: results from an exploratory multiple case study

Sara Levati, Suzanne Hagen, Cam Donaldson, Mary Wells

Barriers to blinding: an analysis of the feasibility of blinding in test-treatment RCTS

Lavinia Ferrante di Ruffano, Jon Deeks

Can we implement findings from RCTs of diagnostic tests? A review of reporting of test-treat interventions

Lavinia Ferrante di Ruffano, Jac Dinnes, Sian Phillips-Taylor, Clare Davenport, Chris Hyde, Jon Deeks

Complex considerations for randomisation across linked randomised trials of complex interventions: illustration from the affinitie programme

Robert Cicero, Rebecca Walwyn, Amanda Farrin, Robbie Foy, Jillian Francis, Natalie Gould, Fabiana Lorencatto, Simon Stanworth

Impact of timing of follow-up upon outcome in the TOPKAT trial

Jonathan Cook, Graeme MacLennan, David Murray, Andrew Price, Ray Fitzpatrick, Andrew Carr, Marion Campbell, Helen Campbell, Nigel Arden, Cushla Cooper, Loretta Davies, David Beard

Methods for standardising and monitoring surgical interventions in RCTs

Natalie Blencowe, Nicola Mills, Jenny Donovan, Jane Blazeby

How pre-trial qualitative research can change proposed RCT design: a case study and implications for future research

Leila Rooshenas, Christel Mcmullen, Jonathan Mathers, Daisy Townsend, Jenny Donovan, Jane Blazeby

“It's what we call a randomised control trial” exploring how randomisation is presented by recruiters in RCTs

Marcus Jepson, Daisy Townsend, Julia Wade, Carmel Conefrey, Jenny Donovan

The importance of rapport and relationship building when recruiting to clinical trials: a qualitative investigation of trial recruitment consultations in a surgical RCT

Lynda Constable, Danielle Pirie, Katie Gillies, Sharon McCann, Suzanne Breeman, Cathryn Glazener

“You have to keep your nerve on a DMC.” Challenges for data monitoring committees in neonatal intensive care trials: qualitative accounts from the bracelet study

Claire Snowdon, Diana Elbourne, Peter Brocklehurst, Martin Ward Platt, Robert Tasker

Using qualitative research to understand what outcomes matter to patients: direct and indirect approaches to outcome elicitation

Jonathan Mathers, Thomas Keeley, Laura Jones, Melanie Calvert, Paula Williamson, Janet Jones, Christel McMullan, Susan Wright, Bridget Young

Synthesising participants’ accounts from different mental health trials: the stride study

Katrina Turner, John Percival, David Kessler, Jenny Donovan

Development of guidance for statistical analysis plans (SAPs) for clinical trials

Ashma Krishan, Deborah Stocken, Steff Lewis, Ed Juszczak, Caroline Dore, Paula Williamson, Doug Altman, Alan Montgomery, Mike Clarke, Carrol Gamble

Beyond total treatment effects in RCTs: why we need to measure outcomes at baseline when investigating mediation

Sabine Landau, Richard Emsley, Graham Dunn

Longitudinal mediation in the PACE randomised clinical trial of rehabilitative treatments for chronic fatigue syndrome: modelling and design considerations

Kimberley Goldsmith, Trudie Chalder, Peter White, Michael Sharpe, Andrew Pickles

Complier-average causal effects for multivariate outcomes: an instrumental variable approach with application to health economics

Karla DiazOrdaz, Angelo Franchini, Richard Grieve

Considering the design effect for the stepped wedge trial: what can it tell us?

Jennifer Thompson, Katherine Fielding, James Hargreaves, Andrew Copas

Assessing sensitivity to assumptions in mixed effects analyses of stepped-wedge trials

Calum Davey, Jennifer A Thompson

Trials recruiting patients in the acute NHS setting: trial management challenges

Seonaidh Cotton, Ruth Thomas, Sarah Cameron, Anne Duncan, Tracey Davidson, Kirsty McCormack

Is over recruitment to a single site problematic for surgical trials?

David Beard, Andrew Price, David Murray, Loretta Davies, Cushla Cooper, Jonathan Cook

Improving efficiency of on-site monitoring in multicentre clinical trials by targeting visits

Carol Knott, Elsa Valdes-Marquez, Martin Landray, Jane Armitage, Jemma Hopewell

The role of an in-house audit group as an innovative tool to review clinical trials

Shivali Trivedi, Krishna Hathi, Natasha Aslam, Nausheen Saleem, Kylie Gyertson, Jeremy Whelan

Blindingly obvious (once revealed): a novel approach to blinding medicinal products for injection

Julia Sanders, Julia Townson, Nadine Aawar

How was it for you? - obtaining feedback from staff at study sites for the HPS2-thrive trial

Christopher Bray, Elizabeth Wincott, Carol Knott, Martin Landray, Jane Armitage

Investigation of the shortcomings of the consort 2010 statement for the reporting of group sequential randomised controlled trials

Munyaradzi Dimairo, Abigail Stevely, Susan Todd, Steven Julious, Jonathan Nicholl, Daniel Hind, Cindy Cooper

Methods for evaluating innovative surgery: a nested ideal phase 2 study within an external randomised pilot (the ROMIO trial)

Jane Blazeby, Richard Berrisford, Dan Titcomb, Andrew Hollowood, Grant Sanders, Christopher Streets, Tim Wheatley, Kerry Avery, George Hanna, Chris Metcalfe, Paul Barham

A systematic review of the use of an expertise-based randomised trial design

Jonathan Cook, Andrew Elders, Charles Boachie, Ted Bassigna, Cynthia Fraser, Doug Altman, Isabelle Boutron, Craig Ramsay, Graeme Maclennan

A framework for the design and analysis of phase III randomised trials in uncommon diseases

Mahesh Parmar, Tim Morris, Matthew Sydes

Design of the myechild trial, an international randomised phase III clinical trial in children with acute myeloid leukaemia incorporating an embedded dose finding study

Aimee Houlton, Brenda Gibson, Keith Wheatley

Comparison of a frequentist and Bayesian response-adaptive randomisation approach in multi-stage phase II selection trials with multiple experimental arms

Christina Yap, Xuejing Lin, Ken Cheung

Introducing personalised risk based intervals in screening for diabetic retinopathy: development, implementation and assessment of safety, cost-effectiveness and patient experience (ISDR): a case study in the use of automated systems in trials

Duncan Appelbe, Deborah Broadbent, Mehrdad Mobayen-Rahni, Antonio Eleuteri, Abigail Bennett, Tracy Moitt, Amu Wang, Marta García-Fiñana, Anthony Fisher, Simon Harding

Video adjudication in clinical trials: enabling distribution of expertise and accurate scoring

Alan Stevenson, Sharon Kean, David Cowan

Experience from creating electronic systems with generic endpoint review and adjudication flows

Jane Aziz, Sharon Kean, Ernest Edifor, Eleanor Dinnett

Design, validity and clinical utility of smartphone app to assess short-term pain trajectories

John Bedson, Kate Dunn, Stephen Dent, Danielle van der Windt

A better participant experience using sms for real time data collection

Jamie Garner, Rhiannon Whitaker

Development and evaluation of an electronic diary for recording patient reported outcomes in the overt study

Duncan Appelbe, Oluseun Adeogun, Nicholas Webb, Rabiya Majeed, Malcom Lewis, Paula Williamson

Evaluating the use of real-time data collection using SMS texts in the SIMS study

Tracey Davidson, Alison McDonald, Gladys McPherson, John Norrie

Data sharing in clinical trials - practical guidance on anonymising trial datasets

Christopher Tuck, Steff Lewis, Garry Milne, Sandra Eldridge, Neil Wright

Supporting clinical trials through healthcare informatics

Claire Jones, Emily Jefferson, Fiona Hogarth, Roberta Littleford, Margaret Band

Challenges of linking to routine healthcare records in UK Biobank

Ligia Adamska, Naomi Allen, Robin Flaig, Cathie Sudlow, Michael Lay, Martin Landray

Are we getting the whole picture? Measuring outcomes using routinely collected data in long term follow-up: an example from BB:2-6

Rebecca Cannings-John, Fiona Lugg, Michael Robling, Gwenllian Moody

Managing the morass. Lessons learned from establishing a data linkage model for long-term follow up of a trial cohort using routine health and education data

Fiona Lugg, Rebecca Cannings-John, Gwenllian Moody, Mike Robling

Can we reduce bias in open-label trials when blinded outcome assessment is not possible? An example from the trigger trial

Brennan Kahan, Vipul Jairath

Selective reporting in clinical trials - an examination of discrepancy rates in pre-specified and reported outcomes in articles submitted to the BMJ

Jennifer Weston, Kerry Dwan, Douglas Altman, Mike Clarke, Carrol Gamble, Trish Groves, Sara Schroter, Paula Williamson, Jamie Kirkham

What is the effect of patient-reported outcome (PRO) item order on prioritisation of PROs in the development of a core outcome set?

Katy Chalmers, Kerry Avery, Karen Coulman, Natalie Blencowe, Rhiannon Macefield, Chris Metcalfe, Jane Blazeby, Sara Brookes

Using existing trial data to inform the development of core outcome sets and improve efficiencies in research

Kim S Thomas, Lucy Bradshaw, Alan A Montgommery, Nick A Francis, Matthew J Ridd, Miriam Santer

Rapid recruitment of large cohort to support trials in general practice: the role of FARSITE

Peter Bower, Kelly Howells, Sheila McCorkindale, Lucy Bridges, Mark Sidaway

Optimising participation and generalisability: the use of opt-out recruitment for an implementation trial in primary care

Suzanne Hartley, Paul Carder, Robbie Foy, Peter Heudtlass, Liz Glidewell, Emma Ingleson, Stella Johnson, Paul Lord, Tom Willis, Amanda Farrin

Recruitment to clinical trials - the use of social media

Will Storrar, Thomas Brown, Lara Balls, Anoop Chauhan, Carole Fogg

Randomized controlled trials: who fails run-in?

Judy R Rees, Leila A Mott, Elizabeth L Barry, John A Baron, Janet L Peacock

Testosterone replacement in young male cancer survivors (TRYMS) - pragmatic adaptation of trial design for a trial struggling with recruitment

Isabelle Smith, Jayne Swain, Helen Marshall, Alexandra Smith, Jennifer Walsh, Richard Ross, Sarah Brown

Learning more from exploratory trials of complex interventions: exploiting the complexity of complex interventions to empirically optimise the content and delivery of intervention packages for evaluation in a confirmatory trial

Rebecca Walwyn, Steven Gilmour, Amanda Farrin, Allan House

Do pragmatic trials trade-off internal validity for external validity?

Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan, Shaun Treweek

Designing, implementing and analysing a virtual trial

Lauren J Scott, Barnaby C Reeves, Usha Chakravarthy, Chris A Rogers

Evaluating statistical characteristics of biomarker-guided trial designs

Miranta Antoniou, Andrea Jorgensen, Ruwanthi Kolamunnage-Dona

Type I error control in biomarker-stratified clinical trials

Deepak Parashar, Jack Bowden, Colin Starr, Lorenz Wernisch, Adrian Mander

Combining multiple predictive markers in stratified medicine

Richard Emsley, Matthias Pierce, Graham Dunn

Prediction of treatment benefit in high-dimensional cox models via gene signatures in randomized clinical trials

Nils Ternès, Federico Rotolo, Georg Heinze, Stefan Michiels

Defining feasibility and pilot studies in preparation for randomised controlled trials: using consensus methods and validation to develop a conceptual framework

Sandra Eldridge, Christine Bond, Mike Campbell, Sally Hopewell, Lehana Thabane, Gill Lancaster, Claire Coleman

Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Alicia O'Cathain, Pat Hoddinott, Simon Lewin, Kate Thomas, Bridget Young, Joy Adamson, Yvonne Jansen, Nicola Mills, Graham Moore, Jenny Donovan

Recruitment progression rules for internal pilot studies monitoring recruitment

Lisa Hampson, Paula Williamson, Martin Wilby, Thomas Jaki

Statistical challenges in assessing potential efficacy of complex interventions in pilot or feasibility studies

Duncan T Wilson, Rebecca E A Walwyn, Julia Brown, Amanda J Farrin, Sarah R Brown

Assessing the impact of patient and public involvement on recruitment and retention in clinical trials: a systematic review

Joanna Crocker, Adwoa Hughes-Morley, Sophie Petit-Zeman, Sian Rees

Developing a toolkit for patient and public involvement in a clinical trials unit

Heather Bagley, Nicola Harman, Kerry Woolfall, Bridget Young, Hannah Short, Helen Hickey, Paula Williamson

Realising the potential of patient and public involvement to make a difference: what can trial teams do?

Bridget Young, Louise Dudley, Paula Williamson, Carrol Gamble

Novel patient engagement and recruitment strategies for an RCY of two NHS treatments for ankle osteoarthritis - total ankle replacement versus arthrodesis - the TARVA trial

Andy Goldberg, Claire Thomson, Deirdre Brooking, Elin Rees, Marion Cumbers, Michelle Tetlow, Simon Skene, Suzie Cro

Improving health in children with disabilities: an intervention-development study to support participation in leisure in 8-12 year olds with communication and mobility limitations

Jennifer McAnuff, Allan Colver, Tim Rapley, Niina Kolehmainen

Using results from a UK-wide survey to justify choice of comparator for the treatment of severe chronic hand eczema

Isabelle Smith, Sarah Brown, Jane Nixon, Miriam Wittmann

What can we learn from experience? Impact of healthcare provider effects in the total or partial knee arthroplasty trial (TOPKAT)

Jonathan Cook, Graeme MacLennan, David Murray, Andrew Price, Ray Fitzpatrick, Andrew Carr, Marion Campbell, Helen Campbell, Nigel Arden, Cushla Cooper, Loretta Davies, David Beard

The stepped wedge cluster randomised trial: an opportunity to increase the quality of evaluations of service delivery and public policy interventions

Monica Taljaard, Richard Lilford, Alan Girling, Karla Hemming

Ingredients, outcomes and mechanisms of change in complex interventions for children with movement limitations: a systematic evidence synthesis

Niina Kolehmainen, Jennifer McAnuff, Annemarie Tissen-Budde

Analysis and reporting of trials which randomise couples to therapy based interventions: how should we do it?

Stephen Walters, Ellen Lee

Addressing treatment contamination in the design and analysis of trials of complex interventions: early results from a systematic review of mental health trials affected by contamination

Nicholas Magill, Khalida Ismail, Paul McCrone, Sabine Landau

Clinical integration and evolution of transanal total mesorectal excision: the ideal framework in practice

Marta Penna, Allison Hirst, Peter McCulloch, Chris Cunningham, Neil Mortensen, Roel Hompes

Developing a process evaluation model in the GASP (groups for alcohol-misusing short-term prisoners) trial

Yvonne Moriarty, Rachel McNamara, Michael Robling, Anna Kissell, Rebecca Playle, Pamela Taylor

Optimising the design of internal pilot work to inform efficient randomised controlled trials: issues to consider when developing progression criteria

Kerry Avery, Paula Williamson, Carrol Gamble, Elaine O'Connell Francischetto, Chris Metcalfe, Peter Davidson, Jane Blazeby

Exploring non-compliance in a cluster randomised feasibility study to inform the design of the phase III trial

Lauren Bell, Vipul Jairath, Brennan C Kahan

The IBRA (implant breast reconstruction evaluation) study: a prospective multicentre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new approaches to implant-based breast reconstruction

Shelley Potter, Jane Blazeby

The quality of reporting of pilot and feasibility cluster randomised trials: a systematic review

Claire Coleman, Clémence Leyrat, Sandra Eldridge

Do pilot trials reliably predict recruitment and retention rates for full trial? A review of HTA funded trials

Amy Whitehead, Cindy Cooper, Steve Julious, Edward Pottrill

When an external pilot is successful, should it be possible to transform it into an internal pilot by continuing recruitment into the full trial is ready? A case study of the cord pilot trial

Lelia Duley, Angela Pushpa-Rajah, Lucy Bradshaw, Jon Dorling, Eleanor Mitchell

Improving the reporting of randomised pilot and feasibility studies: a consort statement extension

Sandra Eldridge, Christine Bond, Mike Campbell, Sally Hopewell, Lehana Thabane, Gill Lancaster, Claire Coleman

How can pilot work optimally inform surgical RCTs? A review of current evidence

Katherine Fairhurst, Kerry Avery, Elaine O'Connell Francischetto, Chris Metcalfe, Jane Blazeby

Collecting sensitive information for a sexual health trial with young people: experiences of using electronic data collection and traditional paper methods

Lisa Maguire, Aine Aventin, Dirk Schubotz, Laura Dunne, Maria Lohan, Mike Clarke

A pilot placebo controlled randomised trial of glyceryl trinitrate for retained placenta (GOTIT trial): assessing the potential for progressing to a full RCT

Susan Morrow, Julia Lawton, Nina Hallowell, Gladys McPherson, John Norrie, Fiona Denison

Pilot randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people: ‘stopcuts’

Roy Powell, Christopher Hayward, Caroline Snelgrove, Kathleen Polverino, Linda Park, Rohan Chauhan, Philip Evans, Rachel Byford, Carolyn Charman, Christopher Foy, Andrew Kingsley

Gauging acceptability: the utility of a national attitudes survey toward a trial of pressure garment therapy for burns scar management

Susan Wright, Laura Jones, Naiem Moiemen, Margaret Grant, Jonathan Mathers

Pilot and feasibility studies: what's the point?

Wei Pek, Martin Ashton-Key, Emma Kirkpatrick, Amanda Young

Study feasibility - visualising the operationalisation of studies from early conception stage

Irena Zwierska, Sarah Bathers

Cost-effectiveness of cognitive behavioural therapy for treatment-resistant depression: challenges and solutions conducting an economic evaluation of the long-term follow-up of the cobalt trial

Kirsty Garfield, Laura Thomas, Tim Peters, Nicola Wiles, Sandra Hollinghurst

External validity of rct evidence in cost-effectiveness analyses. A review of recent technology appraisals for nice and proposed methods of adjustment

Theodoros Mantopoulos, Sofia Dias, Antony Ades, Nicky Welton

Challenges of implementing multiple imputation to address missing data in economic evaluations

Aida Moure Fernandez, Kirsty Garfield, Sian Noble, Daisy Gaunt, Laura Howe, Debbie Lawlor, William Hollingworth

Pragmatic constraint-led approach to sample size

Paul Silcocks, Diane Whitham

Using primary care data to evaluate the 10-year cost-effectiveness of cardiovascular disease risk algorithms in patients with serious mental illness: a patient level simulation

Ella Zomer, Rachael Hunter, Irwin Nazareth, David Osborn

Reliable and accurate data capture using tablets, phones or other mobile devices

Mihaela Barbu

Improving the efficiency of testing database functionality through statistical involvement

Gemma Clayton, Katie Pike, Rachel Nash, David Hutton, Chris Rogers

Quality by design: using intelligent forms to ensure study protocol compliance and participant safety

Rejive Dayanandan, Elizabeth Wincott, Michael Lay, Richard Haynes, Martin Landray, Jane Armitage

Introducing framework for analyzing non-adherence (FAN)

Ernest Edifor, Sharon Kean, Jane Aziz

Use of electronic health records in the design and evaluation of implementation research in primary care - experiences from the aspire cluster randomised controlled trials (CRCTS)

Peter Heudtlass, Robbie Foy, Liz Glidewell, Suzanne Hartley, John Turgoose, Tom Willis, Amanda Farrin

Software for spatial analysis and visualisation of cluster randomised trials - a review of available tools

Christopher Jarvis, Gian Luca Di Tanna, Neal Alexander, Karim Anaya-Izquierdo, James Carpenter

Design considerations when transitioning from paper case report forms (CRFS) to electronic data capture (EDC)

Rebecca Lewis, Leona Batten, Charlotte Friend, Mark Webster-Smith, Stephanie Burnett, James Morden, Elizabeth Hill, Alexa Gillman, Sharon Ereira, Judith Bliss, Emma Hall, Claire Snowdon

A review of the online prognositc model predict using the POSH cohort (women aged ≤40 years at breast cancer diagnosis)

Tom Maishman, Ellen Copson, Louise Stanton, Sue Gerty, Ed Dicks, Lorraine Durcan, Gordon Wishart, Paul Pharoah, Diana Eccles

Benefits and challenges of electronic data capture (EDC) systems versus paper case report forms

Ihtisham Malik, Stephanie Burnett, Mark Webster-Smith, James Morden, Sharon Ereira, Alexa Gillman, Rebecca Lewis, Emma Hall, Judith Bliss, Claire Snowdon

Technological solutions to capture data for patient reported outcomes using mobile devices

Dionne Russell, Jonathan Gibb, Sharon Kean

Assessing the accuracy of routinely collected data and their potential use in pressure ulcer trials

Isabelle Smith, Sarah Brown, Susanne Coleman, Lyn Wilson, Jane Nixon

A web and telephone randomisation service in one hour – the benefits and challenges of delivering a configurable randomisation system

John Turgoose, Will Crocombe

Implementing electronic data capture (EDC) training for site staff

Mark Webster-Smith, Claire Paulding, Stephanie Burnett, Lisa Jeffs, Dalia Ismail, Carolyn McNamara, Sharon Ereira, Rebecca Lewis, Emma Hall, Judith Bliss, Claire Snowdon

Going beyond routine data collection of clinical trials funded by the health technology assessment programme

James Raftery, Amanda Young, Helen Buxton

What are the methodological designs of nihr funded clinical trials? Going beyond routine data collection

Amanda Young, Helen Buxton, Liz Tremain, Tom Kenny

Introduction of electronic data capture method using participant-completed online web-based follow up questionnaire in mail-based study achieves expected benefits and positive participant feedback

Jill Barton, Allen Young, Michael Lay

Surveying clinical trial participant satisfaction

Christopher Bray

A review of the description of patient withdrawal in trial protocols and patient information sheets (PIS)

Anna Kearney, Anne Daykin, Ali Heawood, Athene Lane, Jane Blazeby, Mike Clarke, Paula Williamson, Carrol Gamble

The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection

Kerry Avery, Katy Chalmers, Katie Whale, Natalie Blencowe, Rhiannon Macefield, Sara Brookes, Chris Metcalfe, Jane Blazeby

Assessment of patient-reported adverse events after discharge from hospital in RCTs in gastrointestinal cancer surgery: is there sufficient coverage in existing EORTC questionnaires?

Kerry Avery, Elaine O’Connell Francischetto, Galina Velikova, Jane Blazeby

Difficulties with defining diagnostic accuracy study outcomes

Katie Banister, Craig Ramsay, Jonathan Cook, Charles Boachie, Augusto Azuara-Blanco

Citation analysis: a new approach to assess the uptake of core outcome sets

Karen Barnes, Mike Clarke, Jamie Kirkham, Paula Williamson

Three nested RCTs of dual or single stakeholder feedback within Delphi surveys during core outcome and information set development

Sara Brookes, Rhiannon Macefield, Paula Williamson, Angus McNair, Shelley Potter, Natalie Blencowe, Sean Strong, Jane Blazeby

Outcomes to measure patient safety: the patient reporting and action for a safe environment (PRASE) trial

Hannah Buckley, Kim Cocks, Rebecca Lawton, Jane O'Hara, Laura Sheard, Claire Marsh, Belen Corbacho Martin, Ian Watt, John Wright

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set

Katie Gillies, Cynthia Fraser, Vikki Entwistle, Shaun Treweek, Paula Williamson, Marion Campbell

Minimal clinically important difference (MCID) of the SCL-20 measure of depression severity in patients with cancer and major depression

Bethan Copsey, Jane Walker, Susan Dutton, Rebecca Fisher, Michael Sharpe

Core harm outcome sets developed by drug are needed to allow informed risk-benefit decision making

Victoria Cornelius, Kun Liu, Janet Peacock, Odile Sauzet

Modifying a validated instrument: the Aberdeen varicose vein questionnaire

Aleksandra Staniszewska, Seonaidh Cotton, Graeme MacLennan, Julie Brittenden

Choosing outcomes for a core outcome set: does provision of feedback between delphi survey rounds help prioritise items?

Karen Coulman, Sara Brookes, Katy Chalmers, James Hopkins, Noah Howes, Alex Nicholson, Amanda Owen-Smith, Katie Whale, Jane Blazeby

A comparison of an objective and subjective test of stress urinary incontinence (SUI) and their acceptability to participants

Tracey Davidson, Alison McDonald, Gladys McPherson, John Norrie

Using a consensus technique for improving the methodology of clinical trials assessing treatments for Cutaneous Leishmaniasis

Astrid Erber, Liliana Lopez-Carvajal, Byron Arana, Trudie Lang, Piero Olliaro

A mixed methods study of researchers’ experiences of developing core outcome sets

Elizabeth Gargon, Bridget Young, Paula Williamson

Can vascular mortality be reliably ascertained from the underlying cause of death recorded on a medical death certificate? Evidence from 2800 adjudicated heart protection study (HPS) deaths

William Herrington, Karl Wallendszus, Louise Bowman, Martin Landray, Jane Armitage

Analysis of continuous biochemical parameters in long-term trials of chronic disease where outcomes could be affected by further intervention

Natalie Ives, Samir Mehta, Elizabeth Brettell, Marie Valente, Sunil Bhandari

Improving phase ii oncology trial using best observed RECIST response as an endpoint by modelling continuous tumour measurements

Chien-Ju Lin, James Wason

Are patients and health care professionals influenced by each other's’ opinions about the outcomes to measure in localised prostate cancer effectiveness trials?

Steven MacLennan, Thomas Lam, Paula Williamson

Core outcomes for randomized trials and core information for clinical decision-making: implications for outcome selection

Angus McNair, Robert Whistance, Rachel Forsythe, Rhiannon Macefield, Sara Brookes, Jane Blazeby

Exploring the reasons for the sensitivity to change of a patient preference measure, compared with the KOOS questionnaire in patellofemoral osteoarthritis

Matthew Parkes, Michael Callaghan, David Felson

The current practice of handling and reporting missing outcome data in eight widely-used PROMS in RCT publications: are we doing well?

Ines Rombach, Oliver Rivero-Arias, Crispin Jenkinson, Alastair Gray, Órlaith Burke

Validation of the Vitiligo noticeability scale: a patient-reported outcome measure of Vitiligo treatment success

Jonathan Batchelor, Wei Tan, Selina Tour, Andrian Yong, Alan Montgomery, Kim Thomas

The core outcome measures in effectiveness trials (COMET) initiative: five years on

Paula Williamson, Douglas Altman, Jane Blazeby, Michael Clarke, Elizabeth Gargon, Sarah Gorst, Sean Tunis

Clinicians’ and womens’ experiences of two consent pathways in a trial of timing of clamping at very preterm birth: a qualitative study

Susan Ayers, Alex Sawyer, Celine Chhoa, Angela Pushpa-Rajah, Lelia Duley

The treatment preferences of adolescents and their parents, what has the smile RCT shown us? Smile: specialist medical intervention and lightning evaluation

Lucy Beasant, Nicola Mills, Esther Crawley

Patient and health professionals’ perspectives on the use of ciclosporin and infliximab when treating acute severe ulcerative colitis: an added dimension to the construct trial

Clare Clement, Frances Rapport

Early qualitative analysis to enhance trial processes

Will Storrar, Ann Dewey, Anoop Chauhan, Carole Fogg, Ellie Lanning, Thomas Brown, Lara Balls

Using qualitative interviews with nihr crn research midwives to refine trial recruitment methods

Katharine Foster, Katharine Bowker, Sophie Orton, Felix Naughton, Sue Cooper, Tim Coleman

Qualitative methods and patient and public involvement in trials: opportunities and pitfalls

Pat Hoddinott, Alicia O'Cathain, Isabel Boyer, Sandy Oliver

Q methodology with cognitive interviewing to rank the importance of informational items in a patient information leaflet

Karen Innes, Katie Gillies, Seonaidh Cotton, Marion Campbell

Using conversation analytic methods to explore the content, delivery and receipt of complex healthcare interventions

Rebecca K Barnes, Marcus Jepson, Alison Heawood

Enhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges

A Nicholson, A Daykin, R Macefield, S McCann, G Shorter, M Sydes, C Gamble, A Shaw, JA Lane

What do young people really understand when completing questionnaires? Lessons learnt from developing a questionnaire to measure behavioural outcomes in a sexual health trial

Lisa Maguire, Aine Aventin, Maria Lohan, Mike Clarke

Defining usual care: do we need to think beyond clinical equipoise? A synthesis and secondary analysis of multiple qualitative data sets

Katrina Turner, John Percival, Jenny Donovan, David Kessler

Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial (NCT02092480)

Aine Aventin, Lisa Maguire, Mike Clarke, Maria Lohan

Understanding the role of teamwork in recruitment to randomised controlled trials in surgical oncology-results from an exploratory study

Sean Strong, Sangeetha Paramasivan, Caroline Wilson, Nicola Mills, Jenny Donovan, Jane Blazeby

A poetic story: lessons learnt from the world's largest breast cancer window of opportunity study

Judith Bliss, Alexa Gillman, Lucy Kilburn, James Morden, Kally Sidhu, Maggie Wilcox, Abigail Evans, Christopher Holcombe, Kieran Horgan, Anthony Skene, Raghavan Vidya, John Robertson, Mitch Dowsett, Ian Smith

Testing the effectiveness of user-tested patient information on recruitment rates across multiple trials: meta-analysis of data from the start programme

Peter Bower, Jo Rick, Anne Kennedy, Chris Salisbury, David Collier, David Torgerson, Jonathan Graffy, Shaun Treweek, Sandra Eldridge, Vichithranie Madurasinghe, Peter Knapp, Adwoa Hughes-Morley, Nicola Small

Modelling clinical trial recruitment using poisson processes

Kristian Brock, Christina Yap, Gary Middleton, Lucinda Billingham

People with Parkinson's design clinical trials charter to improve communication about, recruitment to and retention in Parkinson's clinical trials

Jon Stamford, Tom Isaacs, Camille Carroll

The reform patient information sheet sub study - an embedded trial evaluating the enhancement of patient information sheets to improve recruitment

Sarah Cockayne, Joy Adamson, Peter Bower, Belen Corbacho, Caroline Fairhurst, Lisa Farndon, Kate Hicks, Anne-Maree Keenan, Peter Knapp, Sally Lamb, Lorraine Loughrey, Caroline McIntosh, Hylton Menz, Anthony Redmond, Jo Rick, Sara Rodgers, Wesley Vernon, Jude Watson, David Torgerson

SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires: a factorial design, randomised, controlled trial

Kath Starr, Gladys McPherson, Mark Forrest, Seonaidh Cotton

Developing a patient and public involvement intervention to enhance recruitment and retention in surgical trials (PIRRIST): study protocol

Joanna Crocker, Sian Rees, Louise Locock, Sophie Petit-Zeman, Alan Chant, Shaun Treweek, Jonathan Cook, Nicola Farrar, Kerry Woolfall, Richard Bulbulia

Just a simple observational follow-up study?

Lucy Culliford, Tracy Harris, Vhris Rogers, Usha Chakravarthy, Barney Reeves

Does size matter? Trial management strategies to increase response rates. The assessment of physical questionnaire size on response rates (APS) sub-study

Tracey Davidson, Gladys McPherson, Alison McDonald, John Norrie

Improving trial questionnaire response rates using behaviour change theory

Anne Duncan, Debbie Bonetti, Jan Clarkson, Craig Ramsay

Conducting complex intervention trials in populations at risk of diminished capacity

Amanda Farrin, Suzanne Hartley, Liz Graham, Rachael Kelley, Claire Surr, Alys Griffiths, Louise Bryant

Specialist nurses’ perceptions of the barriers and facilitators to inviting adult NHS patients to participate in clinical research studies: a qualitative descriptive study

Caroline French, Charitini Stavropoulou

Recruitment challenges in physiotherapy trials

Varsha Gandhi, Cushla Cooper, Karen Barker

Complexities of trial recruitment in the care home setting: an illustration via the DCM™epic (dementia care mapping™: to enable person-centred care in care homes) trial

Claire Surr, Amanda Lilley-Kelly, Liz Graham, Rebecca Walwyn, Robert Cicero, Alys Griffiths, Byron Creese, Lucy Garrod

Evaluation of the effects of an offer of an incentive on the rate of questionnaire return: a nested RCT

Pollyanna Hardy, Peter Brocklehurst

Development of an online resource for recruitment research in clinical trials (ORRCA)

Nicola Harman, Shaun Treweek, Mike Clarke, Paula Williamson, Pete Bower, Carrol Gamble

Use of a mobile workforce to improve recruitment across multiple sites within a local clinical research network

Robert Hughes, Dawn Beaumont-Jewell, Rachel Taylor, Kylie Gyertson

Advertising patient and public involvement in trials as a way of improving participant recruitment: development of an intervention and its evaluation

Adwoa Hughes-Morley, Bridget Young, Mark Hann, Waquas Waheed

Reported reasons for missing data and the interplay with trial setting

Anna Kearney, Naomi Bacon, Anna Rosala-Hallas, Anne Daykin, Ali Heawood, Athene Lane, Jane Blazeby, Mike Clarke, Paula Williamson, Carrol Gamble

Post-it notes to improve questionnaire response rates in RCTs - findings from a randomised sub-study

Ada Keding, Helen Lewis, Kate Bosanquet, Simon Gilbody, Hannah Buckley, Helen Tilbrook, David Torgerson

Text message reminders to improve questionnaire response rates in RCTs: findings from three randomised sub-studies

Ada Keding, Sally Brabyn, Hugh MacPherson, Stewart Richmond, David Torgerson

“To have, to hold, from this day forward”: understanding current practice regarding the retention of trial participants

Anne Daykin, Athene Lane, Carrol Gamble, Anna Kearney, Jane Blazeby, Mike Clarke, Paula Williamson, Ali Heawood

Innovative methods for optimising clinical trial recruitment and retention within primary care

Sarah Lawton, Simon Wathall

The NICOLA recruitment trial (NICOLA-RT): can you improve recruitment by making zero cost amendments to the invitation letter?

Lisa Maguire, Frances Burns, Mike Clarke

The NICOLA questionnaire trial (NICOLA-QT): a randomised trial of the effect of timing and mode of delivery on the completion and return of a self-assessment questionnaire

Lisa Maguire, Frances Burns, Mike Clarke

Incentives and rewards: what do adult populations truly want? Insights from the physical activity loyalty (PAL) scheme

Helen McAneney, Ruth Hunter, Frank Kee, Mike Clarke

Do people who choose their treatment in a large randomised trial with parallel preference groups differ at baseline from those who agree to random treatment allocation? Results from the protect study

Nicola Mills, Hanan Khazragui, Chris Metcalfe, Athene Lane, Michael Davis, Grace Young, David Neal, Freddie Hamdy, Jenny Donovan

Under-representation of male patients in breast cancer studies

Pankaj Mistry, Louise Hiller, Gulnaz Iqbal, Janet Dunn

Advance telephone notification of follow-up in the healthlines study: a nested study of patients with depression

Louisa Edwards, Chris Salisbury, Katy Garner, Kim Horspool, Alexis Foster, Alan Montgomery

Reasons for non-participation in a randomised controlled trial and the effect of audiovisual material

Neil Nathwani, Amanda Davis, Evgenia Konstantakopoulou, Gus Gazzard

Measuring patients’ experience of clinical trials: results of an exploratory review and stakeholder workshop

Claire Planner

Review of an innovative approach to practical trials: the ‘cohort multiple RCT’ design

Clare Relton, Kate Thomas, Jon Nicholl, Rudolf Uher

Equipoise in action: a qualitative investigation across six pragmatic randomised controlled trials (RCTs)

Leila Rooshenas, Daisy Townsend, Julia Wade, Caroline Wilson, Jane Blazeby, Jenny Donovan

The trialists’ perspectives on the participant retention in mental health randomised controlled trials

Paulina Szymczynska, Stefan Priebe

A systematic review of training programmes for recruiters to randomised clinical trials

Daisy Towsend, Nicola Mills, Jelena Savović, Jenny Donovan

Evaluating informed consent during trial recruitment consultations: development and preliminary evaluation of a new method

Julia Wade, Daisy Townsend, Daisy Gaunt, Kerry Avery, Grace Young, Jenny Donovan

Recruitment to oral steroids for the resolution of otitis media with effusion in children (OSTRICH) study: challenges of a randomised controlled trial in secondary care sites across Wales and England

Cherry-Ann Waldron, Emma Thomas-Jones, Debbie Harris, Vicky Shepherd, Rebecca Cannings-John, Kerry Hood, Nick Francis, Chris Butler

Projection of participant recruitment to primary care research

David White, Daniel Hind

Recruiting to an infant formula-milk feeding trial: lessons from the baby milk trial

F Whittle, K K Ong, S J Griffin, R Lakshman

Methodology for UK recruitment into a large-scale international clinical trial

Elizabeth Wincott, Rejive Dayanandan, Richard Haynes, Michael Lay, Martin Landray, Jane Armitage

Strategies to improve response rates to patient reported outcome measures in a surgical RCT

Jessica Wood, Hanne Bruhn, Jonathan A Cook, Alison McDonald, John Norrie, Angus J M Watson

Calculating the design effect for a cluster stepped-wedge trial with varying cluster size; a case study from a trial in type 2 diabetes

Nuzhat Ashra, Melanie Davies, Kamlesh Khunti, Laura Gray

Randomised controlled trials of group interventions with an individual level comparator: are appropriate statistical methods being used?

Lucy Bradshaw, Alan Montgomery

Analysis of repeated measures of multiple surgical sites within a factorial randomised controlled trial

Gemma Clayton, Katie Pike, Gianni D Angelini, Chris A Rogers

Variance estimation in reference based sensitivity analysis for longitudinal trials with protocol deviation

Suzie Cro, Michael Kenward, James Carpenter

Interim sample size re-estimation in the IIVOP trial

Sarah Dawson, Mike Lee, Simon Bond

The use of randomisation-based efficacy estimators in non-inferiority trials

David Gillespie, Kerenza Hood, Daniel Farewell, Antony Hawthorne, Chris Probert, Rachel Stenson, Peter Barrett-Lee, Angela Casbard, Nick Murray

Analysis of the modified rankin scale in randomised controlled trials in acute stroke: a systematic review

Aimie Nunn, Laura Gray

Identification and evaluation of novel methods for the analysis of ordinal data in acute stroke trials in comparison to ordinal logistic regression

Aimie Nunn, Laura Gray

Stepped-wedge cluster randomised trials: where, when and why?

Michael Grayling, James Wason, Adrian Mander

A flexible method for determining a biomarker positive population based on an efficacy target within a confirmatory study

Chris Harbron

Assessing violations of the proportional hazards assumption in Cox regression: does the chosen method matter?

Louise Hiller, Andrea Marshall, Janet Dunn

Practical barriers and corresponding solutions in applying interrupted time series to PUMA

Chao Huang, Colin Powell, Davina Allen, Kerry Hood, Emma Thomas-Jones, Nina Jacob, Yvonne Moriarty, Fiona Lugg

An empirical evaluation of the impact of missing data on treatment effect

Royes Joseph, Julius Sim, Reuben Ogollah, Martyn Lewis

Statistical inference in randomized consent designs in the presence of Hawthorne

Kyungmann Kim

Time-to-event studies: how robust are inferences when the assumption of independent censoring is in doubt?

Martin Law, Dan Jackson

Analysis and reporting of individually randomised controlled trials with clustering in one arm only: how should we do it?

Stephen Walters, Ellen Lee, Laura Flight, Laura Mandefield, Munya Dimario, Annabel Allison

Bias of complete-case analysis of williams square crossover designs when data are missing not at random

Sofia Bazakou, Robin Henderson, Linda Sharples, John Matthews

Analysis techniques in the presence of non-proportional hazards (PH); application to an ovarian cancer RCT with long-term follow-up

James Morden, Judith Bliss, Rosalind Eeles

Mixed effects approach to the analysis of the stepped wedge cluster randomised trial - accounting for the confounding effect of time

Alecia Nickless, Merryn Voysey, Ly-Mee Yu

The use of multiple imputation (MI) in cluster randomised trials with suspected missing not at random (MNAR) outcome

Rebecca Playle, Elinor Coulman, Dunla Gallagher, Sharon Simpson

Dynamic prediction methods in the BC2001 clinical trial

Nuria Porta, M Luz Calle, Rebecca Lewis, Michelle Snape, Carey Hendron, Nicholas James, Robert Huddart, Emma Hall

Correcting for selection bias in two-stage trials with multiple correlated outcomes: application to seamless phase ii/iii clinical trials

David Robertson, A Toby Prevost, Jack Bowden

A novel approach for obtaining a near complete dataset for time-to-event outcomes in the bronchiolitis of infancy discharge study (BIDS) using an informed multiple imputation technique

Aryelly Rodriguez, Steff Lewis

Estimating the effect of “treatment in the treated” - instrumental variable analysis vs conventional regression methods in the titre-2 trial in cardiac surgery

Chris Rogers, Katie Pike, Jonathan Sterne, Barney Reeves

Adaptive designs for phase II cross-over dose-finding trials using Bayesian model averaging

Sarah Simpson, Lisa Hampson, Thomas Jaki, Byron Jones

Challenges in the design and analysis of a factorial-design cluster randomised trial

Jacqueline Stephen, Robert Lee, Kalliopi Kydonaki, Jean Antonelli, Timothy S Walsh, Christopher J Weir

Managing non-proportionality of hazards (PH) within TNT: a randomised phase III trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced triple negative (TN) or brca1/2 breast cancer (BC)

Holly Tovey, Judith Bliss, Andrew Tutt, James Morden, Katy Jarman, Sue Martin, Sarah Kernaghan, Christy Toms, Lucy Kilburn

The potential of the multivariate multilevel model for analysing correlated multiple outcomes: a simulation study

Victoria Vickerstaff, Gareth Ambler, Rumana Z Omar

Structured exploration of clinical trials data - finding the middle way

James Weatherall

Handling drop-outs which imply a change of treatment: an evaluation of reference-based imputation

Ian White, Royes Joseph, Nicky Best

The role of cluster size and intra-cluster correlations when adjusting for covariates in the analysis of cluster randomised trials

Neil Wright

Factors affecting the impact of covariate adjustment for binary outcomes in randomised clinical trials (RCTS): a simulation study

Ly-Mee Yu, Douglas G Altman

Stratified care for patients with sciatica and suspected sciatica in primary care: the scopic trial protocol (scopic - sciatica outcomes in primary care)

Nadine Foster, Kika Konstantinou, Ruth Beardmore, Kate Dunn, Martyn Lewis, Bernadette Bartlam, Majid Artus, Elaine Hay

Reviewing the evidence supporting predictive biomarkers in European medicines agency indications and contraindications using visual plots

Kinga Malottki, Lucinda Billingham, Richard Riley, Jonathan Deeks

Identification of strata for a trial of a targeted multimodal physiotherapy intervention in patellofemoral pain patients

Chris Sutton, Paola Dey, Jessie Janssen, Michael Callaghan, Jim Richards, Maria Stokes, Denis Martin, John Dixon, Erik Witvrouw, Russell Hogarth, Vasilios Baltzopoulos, Elizabeth Ritchie, Nigel Arden, Rich Masters, Remco Polman, David Turner, James Selfe

Trials trail a long tail

Mike Clarke

Physical rehabilitation interventions for adult intensive care patients across the continuum of recovery: an overview of systematic reviews

Bronwen Connolly, Kathryn McDowell, Brenda O'Neill, Lisa Salisbury, Bronagh Blackwood

One-step individual patient data (IPD) network meta-analysis of survival data using royston-parmar models

Suzanne Freeman, James Carpenter, Jayne Tierney

A novel approach to understanding outcome selection and reporting during the evaluation of innovative surgery from first in human to pragmatic RCT: an evolution review

Noah Howes, Jelena Savovic, Julian Higgins, Jane Blazeby

The utility of PRISMA for abstracts in two cohorts: a comparison of health technology assessment and Cochrane database of systematic reviews 2009-2014

Emma Kirkpatrick, Amanda Young, Kathy Tier, Peter Davidson

Systematic review of randomised and observational evidence of effects of treatments of carotid stenosis to prevent stroke

Kusal Lokuge, Alison Halliday, Richard Bulbulia, Alastair Gray, Borislava Mihaylova

Tweeting links to cochrane schizophrenia group reviews: a randomised controlled trial

Clive Adams, Mahesh Jayaram, Angelique Bodart, Stephanie Sampson, Sai Zhao, Alan Montgomery

The challenges of estimating the prevalence of child maltreatment

Gwenllian Moody, Michael Robling, Kerenza Hood, Rebecca Cannings-John, Alison Kemp

Process evaluation in drugs trials within adult learning disability populations: a systematic review

Elizabeth Randell, Rachel McNamara

A new large-scale meta-epidemiological study on bias in randomized trials using routinely collected risk-of-bias assessments by cochrane reviewers: results from the robes study

Jelena Savovic, Rebecca Turner, David Mawdsley, Julian Higgins, Jonathan Sterne

Systematic review and meta-analysis of the participation rates in clinical trials evaluating non-pharmacological interventions for psychosis

Paulina Szymczynska, Sophie Walsh, Stefan Priebe

Does ‘mapping’ the evidence usefully inform the research question prioritisation process in systematic reviews?

Caroline Main, Jayne Wilson, Martin English, Pamela Kearns, Bob Phillips, Barry Pizer, Sophie Wilne, Keith Wheatley

Role of NIHR HTA clinical trials on subsequent systematic reviews

James Raftery, Amanda Young

Methodological challenges and pragmatic design in randomised controlled trials comparing surgery and rehabilitation

Vandana Ayyar Gupta, Antony Palmer, Ines Rombach, Susan Dutton, Cushla Cooper, Karen Barker, David Beard, Sion Glyn-Jones

A comprehensive approach to the central monitoring of clinical trials

Julie Bakobaki, Sally Stenning, Nicola Joffe, Sarah Meredith

The reform study: a case study of embedded trials

Sarah Cockayne, Joy Adamson, Belen Corbacho, Caroline Fairhurst, Lisa Farndon, Kate Hicks, Anne-Maree Keenan, Sally Lamb, Lorraine Loughrey, Caroline McIntosh, Hylton Menz, Anthony Redmond, Sara Rodgers, Wesley Vernon, Jude Watson, David Torgerson

Site identification and selection: current practices within the trial managers network and NIHR chief investigators

Dawn Coleby, Diane Whitham, Lelia Duley

Can site performance be predicted? Results of an evaluation of the performance of a site selection questionnaire in five multicentre trials

Dawn Coleby, Diane Whitham, Lelia Duley

Reporting remit and function of trial steering committees in randomised controlled trials: review of published literature

EJ Conroy, B Arch, S Lewis, A Lane, MR Sydes, J Norrie, G Murray, NL Harman, C Gamble

Overcoming a trial ‘adverse event’: impact and experiences of a temporary suspension of randomisation in clinical trials

Lynda Constable, Tracey Davidson, Samantha Wileman, Kirsty McCormack, Ruth Thomas, Alison McDonald, Cathryn Glazener, John Norrie

Delivering a drug study in primary care: trial management challenges and solutions

Seonaidh Cotton, Karen Innes, David Price, Graham Devereux

Improving quality and efficiency of trial with a novel approach to standard operating procedures (SOPS): case study from a CTU

Diane Whitham, Lelia Duley, Alex Erven

What are the main inefficiencies in trial conduct? A survey of staff at registered clinical trials units

Lelia Duley, Alison McDonald, Alexa Gillman

Do trial managers know when sites will fail to recruit? Preliminary results from the estimating site performance (ESP) study

Kirsty Shearer, Hanne Bruhn, Anne Duncan, Seonaidh Cotton, Shaun Treweek

Use of patient diaries in conjunction with standard reporting methods: duplication of data or a valuable resource?

Janet Dunn, Bill Harris, Gulnaz Iqbal, Jill Wood, Pankaj Mistry, Joanne O'Beirne-Elliman, Stella Bowcock, Mark Drayson

Impact of retrospective data verification on the results of the academic-led ICON6 trial

Andrew Embleton, Elizabeth Clark, Stephen Townsend, Laura Farrelly, Cheryl Jones, Richard Kaplan

Optimising intervention implementation in the DCM™ epic trial (dementia care mapping™: to enable person-centred care in care homes)

Liz Graham, Claire Surr, Sharon Jones, Amanda Farrin, Rebecca Walwyn, Robert Cicero

Training of staff within randomised controlled trials (RCTS) of health-care interventions: a systematic review of the literature

Athanasia Gravani, Alexandra Nicholson, Athene Lane, Chris Rogers

Clinical trial data visualisation

Cassie Gregson

Independent endpoint event review for the elimination of reporting bias in an open label phase III pharmaceutical trial

Peter Hall, Anna Waterhouse, Isabelle Smith, Julia Brown, Walter Gregory, Guenther Steger, Richard Bell, David Cameron

Exploring the role and functionality of trial steering committees

Nicola Harman, Elizabeth Conroy, Steff Lewis, Gordon Murray, John Norrie, Matthew Sydes, Athene Lane, Doug Altman, Colin Baigent, Judith Bliss, Marion Campbell, Diana Elbourne, Stephen Evans, Peter Sandercock, Carrol Gamble

Streamlining R&D permission for substantial amendments to oncology clinical trials at an NHS site: a case study

David I'Anson, Amy Smith, Natasha Aslam, Kylie Gyertson, Rajinder Sidhu, Smaragda Agathou, Ashparan Gill, Jeremy Whelan

Developing a global core competency framework for clinical research

Tamzin Furtado, Amélie Julé, Liam Boggs, Francois van Loggerenberg, Victoria Ewing, Trudie Lang

Improving communication of clinical trial results: plain English summaries in the NIHR journals library

Emma Kirkpatrick, Liz Brindley, Elaine Williams

Investigating possible fraudulent activity at a research site

Carol Knott, Joanne Henderson, Louise Bowman, Martin Landray

Remote training solutions for complex intervention trials

Rebecca Lewis, Shaista Hafeez, Helen McNair, Joanna Illambas, Charlotte Friend, Emma Hall, Robert Huddart

Why are all multi-centre trial sites not the same? A network analytic approach

Helen McAneney

Challenges of the set-up process for academic led international studies of rare diseases

Elaine McColl, Kate Bushby, Michela Guglieri, Becky Davis, Gillian Watson, Robert Griggs, Kim Hart

The research registry - answering the call to register every research study involving human participants

Riaz Agha, Katharine Whitehurst, Harkiran K Sagoo

Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice

Victoria Shepherd, Jacqui Nuttall, Kerenza Hood, Nadine Aawar, Christopher Butler

The impact of a delayed consent model on trial recruitment - the cream study (children with eczema antibiotic management study)

Victoria Shepherd, Emma Thomas-Jones, Katy Addison, Matthew Ridd, Christopher Butler, Kerenza Hood, Nick Francis

TRYMS: the ethical and practical considerations of a double-blind placebo controlled randomised clinical trial

Jayne Swain, Isabelle Smith, Alexandra Smith, Jennifer Walsh, Richard Ross, Helen Marshall

No drug, no trial? Think again!

Kirsty Sprange, Eleanor Mitchell, Mark Hull, Gill Bumphrey

Establishing a journal club to promote professional development within a trials unit

Fiona Strachan, Chris Tuck, Gina Cranswick, Lorraine Smith

The impact of a two or three-group RCT design on blinding of patients

Kerry Avery, Chris Metcalfe, Paul Barham, Richard Berrisford, Grant Sanders, Andrew Hollowood, Tim Wheatley, Alex Nicholson, Jenny Donovan, Jane Blazeby

Innovative considerations on a phase 2a dose-finding strategy using Bayesian methods and MCP-MOD

Alun Bedding, Julian Zhou

Incorporating historical control data into the design and analysis of clinical trials

Maxine Bennett, William Powley, Jeffrey Wetherington, Adrian Mander

Feasibility work to inform trial design: using collaborative methods for efficient real-time data collection in the operating theatre

Natalie Blencowe

Design, method and application of stopping rules in a phase III 2x2 factorial randomised controlled trial

Megan Bowers, Louise Stanton, Mark Thursz

Smiley faces and the need for careful planning in trials

Mike Clarke, Lisa Maguire, Helen McAneney

The SWAT (study within a trial) programme; embedding trials to improve the methodological design and conduct of future research

Mike Clarke, Gerard Savage, Lisa Maguire, Helen McAneney

A pragmatic approach to the design and calibration of a Bayesian CRM dose finding trial

Michael Cole, Deborah Stocken, Christina Yap

Using an adaptive trial design for an infectious disease in primacy care - challenges in the design and set-up stages

Johanna Cook, Theo Verheij, Alike van der Velden, Herman Goossens, Menno de Jong, Philippe Beutels, Paul Little, Chris Butler

Practicalities of using an adaptive design for decision making within the optima trial: optimal personalized treatment of early breast cancer using multi-parameter tests

Janet Dunn, Andrea Marshall, Amy Campbell, David Cameron, Helena Earl, Iain Macpherson, Christopher Poole, Daniel Rea, Adele Francis, Victoria Harmer, Adrienne Morgan, Nigel Stallard, Andreas Makris, Luke Hughes-Davies, Robert Stein

The use of Bayesian design in two trials in rare cancers

Peter Dutton, Sharon Love, Ade Faleti, Bass Hassan

How best to design a clinical trial that is relevant to practice? Applying PRECIS-2, a trial design tool, to primary care trials

Gordon Forbes, Kirsty Loudon, Shaun Treweek, Stephanie Taylor, Sandra Eldridge

NIHR statistics group imaging studies section: a network for statisticians and researchers using imaging in healthcare research

Julia Forman, Susan J Dutton, Thomas R Fanshawe, Sue Mallett

IntReALL HR and the benefits of adaptive design

Jane Holmes, Sharon Love, Vaskar Saha, Arend von Stackelberg

Simulation work in adaptive dose-finding designs to identify dose-intervals that achieve targets in multiple endpoints

James Howlett, Simon Bond, Adrian Mander, John Todd, Linda Wicker, Frank Waldron-Lynch

Adaptive two-stage bioequivalence trials with early stopping and sample size re-estimation

Franz Koenig, Martin Wolfsegger, Thomas Jaki, Helmut Schütz, Gernot Wassmer

Using re-randomisation to improve patient recruitment and increase statistical power in clinical trials

Brennan Kahan, Andrew Forbes, Caroline Dore, Tim Morris

Estimation bias in survival data within clinical trials that use adaptive seamless designs

Josephine Khan, Peter Kimani, Nigel Stallard, Ekkehard Glimm

Some small sample properties of the EWOC design in dose escalation trials

Nelson Kinnersley

Use of an embedded, micro-randomised trial to investigate non-compliance in telehealth trials

Lisa Law, James Wason

Matching trial design decisions to the needs of those you hope will use the results: the PRECIS-2 tool

Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan, Shaun Treweek

The paediatric hepatic international tumour trial (PHITT): clinical trial design in rare disease

Veronica Moroz, Bruce Morland, Gregory Tiao, Eiso Hiyama, Pamela Kearns, Keith Wheatley

The trials and tribulations of accessing data from routine sources

Graham Powell, Tony Marson, Dyfrig Hughes, Paula Williamson, Catrin Tudur-Smith

The 3+3 versus model-based approach: implementation in the CAPCISUM pancreatic cancer trial

Wendi Qian, Adrian Mander, Andrea Machin, Katy Dalchau, Pippa Corrie

A probability of benefit (AUC) approach to phase II cancer trials

Paul Silcocks

An adaptive trial design for updating the threshold of a continuous biomarker

Amy Spencer, Chris Harbron, Adrian Mander, James Wason, Ian Peers

Determining the sample size for a cluster-randomised trial: Bayesian hierarchical modelling of the ICC estimate

Svetlana Tishkovskaya, Chris Sutton, Lois Thomas, Michael Leathley, Caroline Watkins

A practical application of a novel software solution to aid identification of research participants in primary care - the CREAM study (children with eczema antibiotic management study)

Emma Thomas-Jones, Victoria Shepherd, Katy Addison, Kerenza Hood, Matthew Ridd, Chris Butler, Frank Sullivan, Nick Francis

Trial forge – working together to make trials more efficient

Shaun Treweek

Patient drift and response-adaptive randomisation: impact and solutions

Sofia S Villar, James Wason, Jack Bowden

A toxicity-dependent feasibility bound for the escalation with overdose control approach in phase I cancer trials

Graham Wheeler, Michael Sweeting, Adrian Mander

Phase II trial designs for complex interventions: a single-arm single-stage design for clustered continuous outcomes

Duncan T Wilson, Rebecca EA Walwyn, Sarah R Brown, Julia Brown, Amanda J Farrin

Addressing the barriers to implementing model based designs in dose escalation studies

Victoria Cornelius, Simon Bond

Two-arm randomised futility trials: PD-stat - a futility trial of a potential neuroprotective treatment in people with Parkinson's disease

Siobhan Creanor, Jane Vickery, Vicky Eyre, John Zajicek, Sue Ball, Jordan Elm, Camille Carroll

Comparison of analysis approaches for multi-level vascular imaging data

Julia Forman, Marie Fisk, Joseph Cheriyan, Simon Bond, Ian Wilkinson

Pragmatic approaches to mitigating missing data and research priorities to assess the effectiveness of interventions

Anna Kearney, Anne Daykin, Ali Heawood, Athene Lane, Jane Blazeby, Mike Clarke, Paula Williamson, Carrol Gamble