The Alliance Data and Safety Monitoring Board (DSMB) provides independent oversight of clinical trials conducted by the Alliance for Clinical Trials in Oncology to help protect participants and ensure that studies continue to meet high standards for safety and scientific integrity.
Protecting patient safety and maintaining scientific integrity
The Alliance Data and Safety Monitoring Board (DSMB) provides independent oversight of clinical trials conducted by the Alliance for Clinical Trials in Oncology to help protect participants and ensure that studies continue to meet high standards for safety and scientific integrity. The DSMB monitors all Phase III and randomized Phase II trials sponsored by the National Cancer Institute Cancer Therapy Evaluation Program (NCI/CTEP), as well as selected trials sponsored by the NCI Division of Cancer Prevention (DCP).
The DSMB reviews interim analyses of study outcomes and safety data prepared by the study statistician and makes recommendations to the Group Chair about whether a study should continue, be modified, or be stopped. The DSMB also reviews and approves major proposed changes to study design. Recommendations to close a study or make significant design changes are forwarded to the NCI for review and approval. The DSMB also authorizes the release of study results and data in accordance with Alliance policies and procedures.
DSMB members
The Alliance DSMB brings together experts in medical oncology, hematology, radiation oncology, surgical oncology, biostatistics, bone marrow transplantation, and patient advocacy, along with representatives from the National Institutes of Health.
- Jeffrey Kirshner, MD, Chair
- Sumithra Mandrekar, PhD, Group Statistician
Members
- Paul Barr, MD – University of Rochester
- Michael Carducci, MD – Johns Hopkins University/Sidney Kimmel Cancer Center
- Hetty Carraway, MD, MBA – Cleveland Clinic Foundation
- Christopher Goulet, MD – Montana Cancer Consortium NCORP
- Thomas Julian, MD – Allegheny General Hospital
- Edward Korn, PhD – Division of Cancer Treatment and Diagnosis
- Richard Little, MD – NCI Cancer Therapy Evaluation Program
- Motomi Mori, PhD, MBA – Saint Jude Children’s Research Hospital
- Heather Neuman, MD – University of Wisconsin Carbone Cancer Center – University
- Hospital
- Bernard Parker, MD – National Institutes of Health Clinical Center
- Jane Perlmutter, PhD, MBA – Patient Representative
DSMB policies
For more information about the Alliance DSMB’s responsibilities and procedures, see Section 16 of the Alliance Policies and Procedures.
[Link to Alliance Policies and Procedures] | [Add DSMB Policy]