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Update on the NIHR TMN, BRTC and the Hubs for TMR. Athene Lane. Overview. TMN history and past activities Planned activities BRTC Hubs for Trials Methodology Research. UK TMN history. Network for trial managers on MRC trials Commenced in 1988 2003 joint funding HTA & MRC - 2010

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Update on the NIHR TMN, BRTC and the Hubs for TMR


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overview
Overview
  • TMN history and past activities
  • Planned activities
  • BRTC
  • Hubs for Trials Methodology Research
uk tmn history
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)
uk tmn activities
UK TMN activities
  • One day workshops
    • Project management,
    • Practical GCP
    • Writing study newsletters
  • Website: http://www.tmn.ac.uk/
  • Trial management guide
current status
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
planned activities
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
bristol randomised trials collaboration
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
bristol randomised trials collaboration8
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
  • enquiry-brtc@bristol.ac.uk
bristol randomised trials collaboration9
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
  • enquiry-brtc@bristol.ac.uk
slide10

Collaboration and innovation in Difficult or Complex randomised controlled Trials

http://www.methodologyhubs.mrc.ac.uk/default.aspx

TMH Director: Jane Blazeby

Rhiannon Macefield

slide11

PRISMA flow diagram

Records 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)

benefits of on site monitoring
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
site monitoring disadvantages
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)
prime structure
PRIME structure

Monitoring SOP & report template

Review arranged 8 wks in advance

PRIME

Site visits 1-2 days

Problem solving meeting with senior nurse at close

Written report to CIs & PI within 12 weeks

Utilise report at next review

prime site activities
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
prime site activities16
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
prime advantages for a trial
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