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

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

• Annual meetings with workshops (1999)

• Linking with new trial managers

• Steering group of TM & funders (2006 AL)

UK TMN activities• One day workshops

• Project management,

• Practical GCP

• Writing study newsletters

• Website: http://www.tmn.ac.uk/

• Trial management guide

http://www.tmn.ac.uk/

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?• 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

• 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 Collaboration

• Primary care especially mental health

• Cancer and other secondary care trials

• Qualitative research for trial design and conduct

• Complex trial designs

• [email protected]

mailto:[email protected]

Collaboration and innovation in Difficult or Complex randomised controlled Trials

• •••

••

•Rhiannon Macefield

TMH Director: Jane Blazeby

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

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)

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• 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)

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

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 activities• Group meetings/orientation meeting

• Site recruitment and attrition• Problem solving local issues• Protocol adherence

• Data storage• Site files• Safety reporting• Staff training

Monitoring report findings

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