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
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. 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. 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. Are all the information needed
always included in DSMB
charters?
17%
83%
8
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. 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. 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
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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
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13. Thank you for your attention
Any Questions?
Please send us an inquire at : info@bostonclinicalresearch.com
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