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Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Agenda
• Presentation
• Discussion– Format of meetings– Important issues in trials methodology– Actions for next meeting (if any)
• AOB
• Finish at 11am
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Contents
• RCT methodology– What is included?– Why is it important?– What are the major issues?
• Clinical Trials Methodology Group– What is it for?– How will it operate?
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
What might be includedAll aspects, including (not a complete list):• Trial design• Obtaining funding• Ethics and R&D approvals• Recruitment of clinicians and patients• Informed consent• Follow-up• Outcome measurement• Statistical methods• Methods for economic evaluations• Dissemination and impact of results on clinical
practice.
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Why is methodology important?
• Should use the best methods (always room for improvement)
• Efficiency: trials need to be conducted by the most cost-effective methods
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Why is methodology important?
• Thousands of trials need to be conducted
• Increasing pressure on limited funding
• Improving efficiency will enable more trials to be conducted
• Good for triallists
• Good for patients
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Why is methodology important?
• Lots of problems occur during the conduct of RCTs
• Often we do not have evidence about how to solve them
• We should approach these problems in the same way as clinical questions
• Evidence-based approach
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Why is methodology important?
• Should aim to use high quality research evidence to solve problems in RCT conduct
• Where possible, we need randomised evidence and systematic reviews
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Major methodological issues
• Recruitment of patients
• Retention of patients
• Recruitment and retention of clinicians
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Recruitment of patients
• Poor recruitment very common
• Take longer than expected or fail to reach planned sample size
• Results delayed, more expensive, less useful
• Unlikely to get easier (in UK at least)
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Recruitment of patients
• In ISIS-2 (streptokinase and aspirin for acute MI), estimated that delays to recruitment resulted in up to 10,000 deaths.
Collins R, Doll R, Peto R. Ethics in clinical trials. In: Williams CJ, editor(s). Introducing New Treatments For Cancer: Practical, Ethical and Legal Problems. Chichester: John Wiley, 1992:49-56.
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Recruitment of patients
• Not clear what is the best strategy when faced with poor recruitment
• Many possible interventions but little evidence about their effectiveness
• Likely that different strategies are needed in different situations
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Recruitment of patients
• Cochrane methodology review (Mapstone et al 2002)
• 15 studies, all interventions aimed at patients
• Some non-randomised studies or studies of “mock trials”
• RCTs of other interventions needed
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Retention of patients
• Losses to follow up always cause a problem
• Potentially introduce bias
• Best to prevent by achieving high follow-up rates
• Difficult in some populations
• Best ways to achieve this unknown
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Recruitment & retention of clinicians
• May have major impact on recruitment of patients
• Clinicians may be reluctant to participate if they perceive it will involve extra work
• Or they may agree to participate but fail to recruit any patients
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Recruitment & retention of clinicians
• Protocol for Cochrane methodology review (Rendell et al 2005)
• No randomised studies known
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
What is this group for?• Discussion: Triallists who have
particular problems – opportunity to discuss and get input from colleagues
• Research: identify, design and conduct research projects
• Contribute to setting the research agenda for RCT methodology and building up the literature
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
What research might we do?
• RCTs of interventions to improve trial conduct• Systematic reviews (e.g. Cochrane
methodology reviews)• Observational studies• Surveys e.g. of triallists or published literature• Testing of methods and recommendations for
best practice• Re-analysis of trial data sets
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Methodological research
• Potentially very influential
• Assmann et al.Subgroup analysis and other (mis)uses of baseline data in clinical trials Lancet 355 (9209): 1064-1069 Times Cited: 131
• Hollis S, Campbell FWhat is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 319 (7211): 670+ Times Cited: 174
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
How will it work
• Meetings
• Research projects
• Website
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Meetings
• Opportunity to discuss particular issues
• At present scheduled for about once every 2 months
• Each meeting to have a specific topic
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Meetings - format
• Short presentation outlining the issues
• Discussion
• Action plan
• Feedback/results from ongoing projects
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Research projects
• Groups of interested people to develop and run research projects
• Seek funding if necessary
• Report back to the whole group
Warwick Emergency Care and Rehabilitationwww.warwick.ac.uk/go/emergencycare
Website
• Link from Clinical Trials Unit website
• Notes and slides from meetings
• Information and documents for future meetings
• Information about ongoing projects
• Anything else of interest – ideas?