DSMB - The Focus Group

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DSMB - The Focus Group

  1. 1. Current Trends and Best Practices for Data and Safety Monitoring Board The Focus Group Candida Fratazzi, M.D. President
  2. 2. Outline  Focus Group: DSMB experience 2
  3. 3. Focus Group - The Experts’ Opinion  Multiple therapeutic areas  Current practice  Independence of DSMB  DSMB composition  Preparing the charter  Importance of the DSMB kick-off meeting  What to review during the open session  Pitfalls during the close session 3
  4. 4. Focus Group - Therapeutic Areas 2.5 2 2 2 2 2 2 2 2 Number of MDS 1.5 1 1 1 1 1 0.5 0 4
  5. 5. Focus Group - Years of Experience on DSMB 12 Years of experience 10 10 10 10 9 9 9 8 8 7 6 5 4 4 3 2 0 5
  6. 6. Are DSMB members more often recruited by an independent DSMB service or by the sponsor? Sponsor Marketing 10 Group Sponsor Employees 6 CRO 1 Patient Association 1 0 2 4 6 8 10 12 6
  7. 7. Have there been situations where additional voting members were needed with broader expertise? Ad-Hoc members 12% Ethic specialist Specialists for safety signals 13% 62% Replace 13% absentees 7
  8. 8. Are all the information needed always included in DSMB charters? 17% 83% 8
  9. 9. Do you find it useful to have a kick-off meeting? What should be covered? Study DSMB end-points procedure 19% 16% Previously Tasks & Reported AEs responsibility (IB) 16% 19% 11% Ethical issues Action items 19% 9
  10. 10. What is needed to be shared during the open session to engage in a successful and efficient close session discussion? Tasks and Review Charter responsibilities 26% 20% Experienced chairman 26% Review TGL 18% Review Protocol 10% 10
  11. 11. What are the most common pitfalls in closed sessions? Conflict of Unclear and interest incomplete presentation 18% Never 25% experienced issues 14% 25% 18% Challenging Unclean data safety profile 11
  12. 12. Conclusions- DSMB Characteristics Should be: Independent  Avoid conflict of interest  Protect patient safety  Assure trial integrity Should be: Multidisciplinary  Broad medical expertise in the voting panel – Disease specialists – Therapeutic area experts according to study treatment safety profile  Medical drug-safety and risk-management expert 12
  13. 13. Thank you for your attention Any Questions? Please send us an inquire at : info@bostonclinicalresearch.com 13

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