Study Monitoring / DSMB

The Alliance Data and Safety Monitoring Board (DSMB) monitors all phase III and randomized phase II trials sponsored by the National Cancer Institute Cancer Therapy Evalutation Program (NCI/CTEP), and select trials sponsored by the NCI Division of Cancer Prevention (DCP). The DSMB reviews interim analyses of outcome and toxicity data that are prepared by the study statistician, and makes recommendations to the Group Chair concerning whether the study needs to be continued, changed or terminated. In addition, the DSMB reviews and approves major modifications to studies that are proposed by the study team. All DSMB recommendations for study closure or study design changes are forwarded to the NCI for review and approval. In addition, the DSMB authorizes release of study data results.

The Alliance DSMB policy can be found in Section 16 of the Alliance Policies and Procedures or if preferred, download a copy.

  Alliance DSMB Members / Download member roster

Member
Jeffrey Kirshner, MD (Chair)
Sumithra Mandrekar, PhD
(Group Statistician)
Michael Carducci, MD
Susan Ellenberg, PhD
Christopher Goulet, MD
Thomas Julian, MD
Randolph Marks, MD
Robin McLeod, MD
Farhad Ravandi-Kashani, MD
Patricia Spears

NIH Representatives
Edward Korn, MD

Richard Little, MD
Diane St. Germain, MS, RN

 

 

 

 

 

 

 

 

 

 

 

 

 


 


 

Expertise
Hematology/Oncology
Biostatistics

Oncology/Urology
Biostatistics
Radiation Oncology
Surgical Oncology
Hematology/Oncology
Surgical Oncology
Hematology/Oncology/Bone Marrow Transplant
Patient Advocacy

Program
Division of Cancer Treatment and Diagnosis,
Biometric Research Branch
CTEP, Clinical Investigations Branch
Division of Cancer Prevention