AE, Closeout, and multicenter trial Feb2014

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My lectures on Feb2014

My lectures on Feb2014

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  • 1. Assessing and Reporting Adverse Events Thira Woratanarat MD MMedSc DHFM Faculty of Medicine, Chulalongkorn University
  • 2. Three categories of adverse event (AE) • Serious adverse events (SAEs) • General adverse events (AEs) • AEs of special interest
  • 3. SAEs • • • • Life threatening Result in hospitalization Irreversible, persistent, or significant disability/incapacity Congenital anomaly/birth defect PS: SAEs must be reported to regulatory agencies within a fixed time period (e.g. 7 days) of their occurrence
  • 4. General AEs • Complaints by trial participants • Investigator’s observation PS: can be very mild to severe, variation in reporting
  • 5. AEs of special interest • Due to high variation in general AEs reporting, some trials can designate this kind of AEs since they may seriously affect the interpretation and applicability of any new interventions. • For instances, liver function test abnormalities or changes in QT interval on an electrocardiogram
  • 6. Advantages to AEs assessment • Prospective safety determination • Hypothesis testing • Credibility
  • 7. Classification of adverse events • International conference on harmonization (ICH): Medical terminology in 1994 • Medical directory for regulatory activities (MedDRA): Version 2 in 1997 • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0
  • 8. What to consider in reporting AEs • • • • • • Ascertainment Dimensions: Information richness Length of follow-up Scientific explanation/biological plausibility Timing regarding regulatory requirements Solutions and outcomes
  • 9. Closeout Thira Woratanarat MD MMedSc DHFM Faculty of Medicine, Chulalongkorn University
  • 10. Termination procedures • • • • Planning Scheduling of closeout visits Final response ascertainment Transfer of post-trial care
  • 11. Data and other study materials • Cleanup and verification • Storage
  • 12. Dissemination of results • Single vs Multi-center trial • Target groups • Scientific meeting presentation: Congress organizer, Investigators, and Journal editors
  • 13. Post-study follow-up • Return to normal states • Tapering period of some drugs/interventions • Delayed differential effects or events among groups
  • 14. Multi-center trial Thira Woratanarat MD MMedSc DHFM Faculty of Medicine, Chulalongkorn University
  • 15. Multi-center clinical trial • • • • • More difficult More expensive Less professional rewards: need to share credit Logistically challenges Challenges in personnel training and data quality control
  • 16. Reasons to conduct multi-center trial • To recruit adequate number of participants within reasonable time • More generalizable sample • Enable investigators with similar interests and skills to work together on a common problem
  • 17. Steps • Planning committee • Feasibility assessment of the study • Not only clinical centers but also coordination center(s): Regional sites, academic centers, or contract research organizations • Provision of detailed outline of the study to prospective investigators as early as possible: Engagement issues • Monitoring committee: Scientific, DMC/DSMB • Training and standardization mechanisms • Performance management and monitoring mechanisms • Publication, presentation, and authorship policies