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Trial management and governance

Trial management and governance. Useful guidelines. Good clinical practice guidelines (International conference on harmonisation – ICH) It covers areas such as Trial documentation Data protection Safety procedures Good practice in trial conduct (e.g. Standard operating procedures)

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Trial management and governance

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  1. Trial management and governance

  2. Useful guidelines • Good clinical practice guidelines (International conference on harmonisation – ICH) • It covers areas such as • Trial documentation • Data protection • Safety procedures • Good practice in trial conduct (e.g. Standard operating procedures) • Funding bodies – online courses

  3. Research sponsor Research funder Ethics committee Research governance Audit Trial steering committee Data monitoring committee Independent oversight Independent Randomisation service TM subgroup (fidelity) Trial Management group Principal investigator TM subgroup (qualitative work) Trial manager/office TM subgroup (recruitment) Therapy supervisors Therapists Researchers (Supervision Meetings) Trial participants

  4. The Trial Management Group • PI, trial manager, plus research team • May have additional interested outsiders • Oversees all aspects of trial management • May have sub-groupings

  5. Issues in day to day management • Recruitment, assessment queries • Keeping patients on schedule • Maintaining blindness • Communication between different parts of trial team (via trial manager…) • Data standards and protection • Documentation and trial master file

  6. The trial master file • Contains all the documents outlining trial approvals and procedures (e.g.) • Ethics and research governance approvals • Contracts • Financial record • Protocol and amendments • All trial documentation

  7. The composition and role of the Data Monitoring Committee • Independent chair, independent statistician and one other member • Role is to ensure that trial is still ethical, is being conducted properly • Receives report from PI on “new information” • Adjudication of adverse events, complaints, • Considers whether dropouts from treatment, deviations from protocol are prejudicing trial • May ask to see (and analyse) unblinded data • Reports to Trial Steering Committee

  8. Role of Trial Steering Committee • Independent consideration of wider aspects of trial management and progress • Members with expertise in different aspects of trial, including service users • Supportive and advisory role • Concerned with all aspects of trial from approving the protocol to publication policy

  9. Adverse events (AEs) • How are these judgements made? • Who makes these judgements? • What action needs to be taken? Suspected unexpected serious adverse reactions SUSAR

  10. Serious adverse events • Result in • death • a life-threatening situation • hospitalisation or extension of hospitalisation • significant disability or incapacity • congential abnormality or defect

  11. Think about what might and might not be expected in advance and write it down • Take advice – use your independent committees • Timeline for reporting, who will do it? • Prepare an annual summary of adverse events (even if nul report) for DMC

  12. Who needs to be informed? • Adverse event reporting form • Report serious adverse reactions immediately to • Trial sponsors • Research hosts • Ethical approvers (MREC) • DMC and Trial Steering Committee • Patient's GP (with patient’s permission)

  13. Multi-centre trials • Several centres working simultaneously to same protocol • (sometimes different sites perform different parts of protocol, e.g. one site may have imaging facilities) • Coordinating centre ensure standardization across sites • Data from centres combined and analysed together

  14. Why? • Masochistic tendencies on part of triallists • Increase sample size • More likely to be generalisable • Access to range of expertise and facilities

  15. Particular management and governance challenges • Needs a coordinating centre and site management teams • Each centre needs a centre leader • Site preparation can be extensive • Site visits to ensure protocol compliance • Establishment of common goals and standards – keeping the sites in harmony • Newsletters • Importance of agreed policies (e.g. add-on studies, publications)

  16. Maximising publications • Have a publication policy • Have a procedure for discussing and approving add on studies, so that good ones are designed • What can you publish while waiting for the main trial results? • What additional papers can be published after the main trial results?

  17. Publication bias • Negative trials are less likely to be published • Vecchi et al., 2009, review of abstracts, addiction studies, negative/null results had half the likelihood of publication • Role of trial registration • Many studies do not report their primary outcomes e.g. Mathieu et al., 2009

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