Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com

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Determining Need for DSMB • What is the risk to trial participants? • An interim analysis of a study endpoint could be so highly favorable or unfavorable that study termination would be required • Reasons exist for a safety concern • Fragile population • Large, long duration and multicenter trial
Determining Need for DSMB (2) • Is DSMB review practical? • Short duration of trial would limit the meaningful impact of DSMB • Limited value for early studies (Phase I or early Phase 2) where accumulating results are known to sponsor and statistical interpretation of interim data is less relevant
Page 1 and 2: Quality Control in Clinical Trials
Page 3 and 4: Documentation • Most important to
Page 5 and 6: • During the study Blinding • U
Page 7 and 8: Blinding • Safety monitoring •
Page 9 and 10: Clinical Event Committees • Devel
Page 11 and 12: • CRF Design Core Labs • Design
Page 13 and 14: Data Standards • Design effective
Page 15 and 16: Data Standards • Determine Access
Page 17: Functions of DSMB • Reviews the a
Page 21 and 22: DSMB Relation to Other Groups • I
Page 23 and 24: DSMB Charter • Procedural issues
Page 25 and 26: Independence of DSMB • Independen
Page 27 and 28: Independence of DSMB (3) • Indepe
Page 30: Thank You

Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com

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