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Update on the NIHR TMN, BRTC and the Hubs for TMR
Athene Lane
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Overview• TMN history and past activities
• Planned activities
• BRTC
• Hubs for Trials Methodology Research
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UK TMN history• Network for trial managers on MRC trials
• Commenced in 1988
• 2003 joint funding HTA & MRC - 2010
• Annual meetings with workshops (1999)
• Linking with new trial managers
• Steering group of TM & funders (2006 AL)
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UK TMN activities• One day workshops
• Project management,
• Practical GCP
• Writing study newsletters
• Website: http://www.tmn.ac.uk/
• Trial management guide
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Current status• NIHR TMN reflecting funding changes
• NETSCC funding the network
• Base in Leeds CTU, CTRU: Vicky Napp
• Network coordinator tba
• Activities to resume in 2011
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Planned activities?• Eligibility: NIHR portfolio studies and EME
• Reinstate the annual meeting
• Update trial management guide
• Website and discussion board facility
• Newsletter, inc new trial developments
• Signpost TM relevant training opportunities
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Bristol Randomised Trials Collaboration
• NCRI accredited and UKCRC registered CTU
• School of Social and Community Medicine
• Director: Alan Montgomery, Associate: AL
• Management group: statisticians, health
economists and social sciences
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Bristol Randomised Trials Collaboration
• Primary care especially mental health
• Cancer and other secondary care trials
• Qualitative research for trial design and conduct
• Complex trial designs
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Bristol Randomised Trials Collaboration
• Primary care especially mental health
• Cancer and other secondary care trials
• Qualitative research for trial design and conduct
• Complex trial designs
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Collaboration and innovation in Difficult or Complex randomised controlled Trials
• •••
••
•Rhiannon Macefield
TMH Director: Jane Blazeby
http://www.methodologyhubs.mrc.ac.uk/default.aspx
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PRISMA flow diagramRecords identified through
database searching(Embase: 529, Medline: 536)Additional records identified
through other sourcesn= 33
(Hand search of CT/CCT/CCT, referenced in other papers , personal knowledge)
Records after duplicates removed(n =678)
Records screened(n = 678)
Records excluded (n = 526)
Full-text articles assessed for eligibility
(n =152)
Full-text articles excluded (n = 117)Reasons inc: Safety monitoring only, central monitoring only, monitoring of specific procedure only e.g. radiotherapy QA, no monitoring details/ does not discuss monitoring methods, site visits excluded monitoring conduct, not full paper.
(Waiting on 1 inter-lib loan)
Articles included in review(n = 68)
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Benefits of on-site monitoring• Identified problems, e.g. procedural errors (weighing) and
data inconsistencies
• Issues resolved quicker, e.g. increased recruitment
• Improved protocol adherence and GCP compliance
• Greater central & site staff interaction and between sites
• Shared best practice between sites
• Opportunities for additional training
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Site monitoring disadvantages• Costs ($800-1500/visit) or 0.1% annual budget NCI
• Staff time (1-2 days per visit)
• Environmental impact of travel to sites
• Visits created potential for staff friction or harassment
• Little evaluation of benefits or disadvantages
• “On-site monitoring is the only type intended to seek out
sloppiness and fraud” (Cohen 1994)
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Written report to CIs & PI within 12 weeks
PRIMESite visits 1-2 days
PRIME structure
Problem solving meeting with senior
nurse at close
Review arranged 8 wks in advance
Monitoring SOP & report template
Utilise report at next review
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PRIME site activities
• Observation of recruitment & follow-up appointments
• Major focus and most informative aspect
• Individual feedback – mentoring and training role
• CRF completion during/after appt
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PRIME site activities• Group meetings/orientation meeting
• Site recruitment and attrition• Problem solving local issues• Protocol adherence
• Data storage• Site files• Safety reporting• Staff training
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Monitoring report findings
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Monitoring report findings
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PRIME advantages for a trial
• Focuses on trial staff, including as reviewers
• Standardises conduct across staff (including data collection) & shares good practice
• Assists with overall staff training
• Potential for study performance gains
• Early notice of any issues
• Improves GCP compliance, e.g. site file