The presentation can be downloaded from here : http://bostonclinicalresearch.com/dsmb-the-focus-group/

1. Current Trends and Best Practices for
Data and Safety Monitoring Board
The Focus Group
Candida Fratazzi, M.D.
President

2. Outline
 Focus Group: DSMB experience
2

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. 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. 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
12

13. Thank you for your attention
Any Questions?
Please send us an inquire at : info@bostonclinicalresearch.com
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