27 November 2024 – Utrecht (Vredenburg 19)
Instructors
– Prof Kit Roes (Radboud UMC)
– Prof Saskia le Cessie (LUMC)
– Dr. Rob Kessels (Utrecht UMC)
Learning objectives
• Have state-of-the art knowledge of objectives, roles and responsibilities of DSMBs
• Knowledge of when (for which trials) to consider DSMBs and associated roles.
• Knowledge of preferred and common composition of DSMBs.
• Knowledge of the key statistical principles of data monitoring.
• Awareness of key complexities in actual decision making in DSMBs due unexpected observations, unplanned changes, interactions with investigators, sponsors and regulators.
• Basic understanding and experience to act as member of a DSMB.
• Able to critically evaluate DSMB roles, responsibilities and procedures as laid down in charters.
• Able to give input to charters.
• Entertain a broader perspective on role and impact of DSMBs.
• Appreciate the responsibility of DSMB members towards patients and society.
• Appreciate the multidisciplinary nature of the decision making within DSMBs.
Program
The program consists of interactive lectures interchanged with exercises in small groups. Study material (presentations, exercises and reading material) will be in English, verbal language will depend on group composition (Dutch or English). It will greatly enhance the value of lectures and discussion if the study material shared before the course is studied on beforehand.
General schedule
The course will begin at 9:30, with coffee and tea available from 9:00. It will conclude at 15:30, followed by drinks from 15:30 to 16:30. Lunch is included.
Session details
Morning (09.30-12.30)
1. General introduction: Objectives, roles and history of DSMBs
2. Assignment (a): First evaluation of a DSMB Charter
3. Small break
4. Case based reflection on procedures, responsibilities and communication
5. Statistical principles of data monitoring in clinical trials (1)
Afternoon (13.00-15.30)
6. Assignment (b): Act as DSMB – propose advice based on interim data
7. Case based reflection on interim decision making
8. Statistical principles of data monitoring in clinical trials (2)
9. Assignment (c): Act as DSMB – propose advice based on interim data
10. Close-up
Costs
50 euro for VVS/BMS-ANed members, 100 euro for non-VVS/BMS-ANed members.
Please note that participation is limited to 25 participants, and places will be allocated on a first-come, first-served basis.
Registration
Please fill out the form below: