The HRB-TMRN also hold webinar presentations -
Cory Goldstein and Dr Monica Taljaard
When and how we cluster and cross over: methodological and ethical issues
Spence et al. describe the need for more randomized controlled trials to provide rigorous evidence of the real-world effectiveness of treatments and treatment strategies in anesthesia practice. This call is supported by evidence citing a large degree of individual practice variability among cardiac anesthesiologists regarding benzodiazepine use within the standard of care.1 They describe the cluster randomized crossover design as ideal for this purpose. In the proposed approach, they “seek to evaluate the impact of two different approaches to cardiac anesthesia, one where nearly all patients receive intraoperative benzodiazepines unless there are contraindications (routine benzodiazepine arm), and the other where nearly all patients receive no intraoperative benzodiazepines unless there are contraindications (benzodiazepine restricted arm)…during 12, four-week crossover periods”.1 The interventions are implemented as policies such that all eligible patients in the hospital during each period receive the allocated interventions by default without any patient recruitment or consent. While we do not dispute the need for rigorous evidence to inform policy and practice, we have concerns regarding the methodological and ethical issues raised in trials such as the B-Free trial.
Tuesday May 22
Anna Kearney, University of Liverpool
Improving Retention in Clinical trials: Retention strategies, Research Priorities and Useful Resources
Anna Kearney is a Trials Methodology researcher within the Clinical Trials Research Centre at the University of Liverpool. Over the last 6 years she has undertaken a number of methodological research projects, predominantly investigating the recruitment and retention of participants in Clinical Trials. At present she is coordinating a team of over 20 reviewers from across five nations as part of the ORRCA/ ORRCA2 project. ORRCA (www.orrca.org.uk) is a free, online, searchable, resource aimed at helping trial teams and methodologists navigate literature on recruitment and identify effective recruitment strategies relevant to different types of trials. Thousands of articles are currently being reviewed in order to update the resource and to extend it to include retention research.
To view previous the HRB-TMRN Webinars see here.
HTMR TC WG Webinars 2019
18th September, 13:00
"Its not science, its fun": Teaching kids about randomised trials
Dr Linda Biesty & Prof Declan Devane
Health Research Board -Trials Methodology Research Network, Ireland
In this joint MRC-HTMR Network - HRB-TMRN webinar, the presenters will share both their experiences, and fun, of the HRB-Trials Methodology Research Network (HRB-TMRN) 'START – Schools Teaching Awareness of Randomised Trials’ initiative. START helps inform the public, and children in particular, about why randomised trials are important and how they are planned, designed, analysed and reported. START does this by running a unique, national competition in Ireland that challenges primary school children (aged 8-12) to plan, design, conduct, analyse and report their own randomised trial. The competition coincides with International Clinical Trials Day which takes place every year on May 20th, which celebrates the first well documented trial by James Lind in 1747.
To join this lunchtime webinar please follow this link:
HTMR TC WG Webinar 2019 recordings
How to design a dose-finding study using the Continual Reassessment Method
Simon Bond, NIHR Cambridge Clinical Trials Unit, University of Cambridge
Graham Wheeler, Cancer Research UK & UCL Cancer Trials Centre
Christina Yap, The Institute of Cancer Research, London
The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting the MTD than traditional rule-based approaches such as the 3 + 3 design, which is used in most phase I trials. However, the CRM’s uptake in clinical research has been incredibly slow, putting trial participants, drug development and patients at risk.
We present a structured framework for designing a dose-finding study using the CRM. We provide recommendations for key design parameters, advice on conducting pre-trial simulation work to tailor the trial’s design, and guidance on how to conduct and report dose-finding studies using the CRM. We also run through an example case-study where the CRM has been applied in practice. Our associated paper (Wheeler et al., 2019; BMC Med Res Methodol) also provides practical tools to support clinicians and statisticians, including software recommendations, and template text and tables that can be edited and inserted into a trial protocol.
Lastly, we will present dtp-crm, a newly developed interactive web application that can be used to design and conduct a CRM through a useful visual tool, Dose Transition Pathways (Yap et al., 2017; Clinical Cancer Research).
A recording of this webinar will be available soon.
Katie Gillies, University of Aberdeen
Trial retention: priorities for research and participant centred evidence.
This webinar will present the PRIORITY II project which is a James Lind Alliance priority setting process that identified the Top10 research questions for trial retention. Katie will then present findings from projects focusing on understanding participant perspectives in relation to trial retention and set these in ongoing work to develop participant centred retention interventions.
A recording of this webinar will be uploaded soon.
Shaun Treweek, University of Aberdeen
Too much of a good thing? Are we collecting more data than we need?
Trials clearly need data but can we have too much, or at least more than we need? This webinar will highlight the potential for weighing trials down with more data than are needed. It will lean on Trial Forge work in a project called DataCat as well as outline a new project called ORINOCO that looks at the amount of time spent collecting outcome data.
A recording of this webinar will be uploaded soon.
Clare Clement, University of Bristol
Trials rarely recruit well or complete on time and one contributory factor is clinician engagement. This situation is often worse in surgical trials, where treatment preference is strong and research-active senior surgeons are rare. Trainee Research Collaboratives (TRCs) have recently been set up in the UK and have successfully conducted large, multi-centre surgical trials.
We conducted a study to understand the key elements of success within the TRCs and their trials and developed strategies for enhancing trainee engagement in research. This webinar will discuss the motivations of trainees to engage in research, the challenges they face and how these have been overcome. It will outline five key strategies to enhance engagement and contribute to trials being delivered on time and target.
Ashma Krishan, University of Liverpool
The most commonly used approaches for the analysis of time-to-event (TTE) outcomes impose an assumption of proportional hazards (PH). Methods are available for assessing the validity of the PH assumption, however, the assumption is not always checked or reported for validity. The webinar will focus on the results from a recent review of systematic reviews which was conducted to understand the methodology used for analysing TTE outcomes and how often the PH assumption is assessed.
29 January, Sharon Love and Vicki Yorke-Edwards, UCL
In 2013 the FDA and EME suggested risk-based monitoring was acceptable and ICH concurred in 2016. There have been a handful of studies showing that risk-based monitoring is acceptable, that triggers are useful and that maybe on-site SDV is not necessary. However there has been little guidance on how we should carry out central monitoring or on-site monitoring. We will give the results of a survey which aimed to find out how UKCRC registered CTU in the UK carry out monitoring for phase III CTIMPs.
HTMR TC WG Webinar Recordings 2018
28 November 2018 'Making more of your study by using SWATs' Lucy Culliford, Research fellow, Bristol University
This webinar will discuss the embedding of SWATS to answer methodological questions in a large cohort study, and then focus on one completed SWAT on the formatting and appearance of PILs.
31 October 2018 'Challenges of conducting a pre-hospital emergency care trial: Experiences from the PARAMEDIC2 trial' Charlotte Scomparin Warwick CTU, University of Warwick
The talk will focus on challenges encountered in the management of the PARAMEDIC2 trial (a pre-hospital randomised controlled trial of adrenaline versus placebo in the treatment of out-of-hospital cardiac arrest). Topics will include using a waiver of consent, public communication about the trial, randomisation, training and data collection.
27 September 2018 'Mapping Recruitment Research Literature: What’s next?' Anna Kearney, University of Liverpool
Following the review of 56,000 papers, an online database of articles exploring recruitment to Clinical Trials has been developed. This webinar presents an exercise mapping the eligible literature against 42 recruitment themes to understand what research has been undertaken and what is yet to be explored. www.orrca.org.uk
18 June 2018 'Ethical Issues in Emergency Cardiovascular Trials' Alexander Perkins, Trial Manager, LSHTM
This webinar examines the ethical issues raised when conducting research in an emergency context. Using two emergency cardiovascular trials (ERIC-PPCI and ARREST) as case studies, the talk explores the potential consenting methods and trial designs available to facilitate emergency research.
29 May 2018 'Audio-recording recruitment consultations – an exploratory study in two RCTs to investigate the impact on randomisation rates' Professor Chris Rogers, University of Bristol.
25 April 2018 'Changing platforms without stopping the train: A Data Management Perspective on the operational aspects of adaptive platform trials' Lindsay Masters, Data Scientist, MRC Clinical Trials Unit at UCL
The talk provides an overview of running adaptive platform trials from a data management perspective, including experiences of running the STAMPEDE and FOCUS4 trials.
13 April 2018 'This is a platform alteration: A Trial Management Perspective on the operational aspects of adaptive and platform protocols' Dr Francesca Schiavone, MRC Clinical Trials Unit at UCL.
The talk provides an overview on running adaptive platform trials from a trial management perspective. Francesca shares her experience in running the STAMPEDE and FOCUS4 trials, with an emphasis on the operational complexities of adding a new research comparison to an ongoing platform.
2 March 2018 'Achieving clinician buy in for challenging trials: lessons from the paediatric critical care setting' Dr Kerry Woolfall, University of Liverpool.
26 January 2018 'Recruitment in HIV trials: challenges and lessons' Dr Lucy Campbell, Kings College London.
17 October 2017 'Triggered or routine site monitoring visits for randomised controlled trials? Results of TEMPER, a prospective, matched-pair study' Dr William Cragg, MRC Clinical Trials Unit at UCL
19 May 2017 'Why we should do recruitment and retention projections, and how to use them' Professor Shaun Treweek, Health Services Research Unit, University of Aberdeen
31 March 2017 'Methods to manage the randomisation and treatment of patients 24/7 in a large multi-centre RCT'. Dr Rachel Brierley, Senior Research Associate in Clinical Trials Management, School of Clinical Sciences, University of Bristol
27 February 2017 'Recruiting 15,000 trial participants by mail' Dr Louise Bowman, Associate Professor, CTSU, University of Oxford
27 January 2017 'What are TwiCs and how are they being used?' Dr Clare Relton, Senior Research Fellow, School of Health & Related Research, University of Sheffield
12 December 2016 ‘The ORRCA Database: Helping you access relevant recruitment research for clinical trials’ Anna Kearney, Researcher within the North West Hub for Trials Methodology Research, University of Liverpool
11 May 2016 'You have to keep your nerve on a DMC: Challenges for data monitoring committees in a neonatal intensive care trials' Dr Claire Snowdon, Lecturer at the Department of Medical Statistics, London School of Hygiene & Tropical Medicine
11 February 2016 ‘Clinical trials safety and regulation: application of risk-based methodological approaches’. Christina Reith, Clinical Research Fellow, CTSU, University of Oxford
The HRB:Trials Methodology Research Network (Ireland) hosted a webinar by Professor Paula Williamson, Chair of the HTMR Network, on 14 December 2015. Find out more.
Our colleagues at the HRB-TMRN (Trials Methodology Research Network, Ireland) also host regular webinars. Full listings of upcoming webinars, and recordings of previous, can be found on their site.
Find out more about the Working Groups and their interests.