“By combining expertise from so many different organizations, we were able to truly address universal concepts and make a resource that’s applicable to a wide range of scientists and researchers” - Tamsin Knox, associate director of Regulatory Affairs at Tufts Clinical and Translational Science Institute and DSMB Training Manual editor.
Monitoring patient safety and protecting patient data is without question one of the most important aspects of clinical research. One of the ways researchers look to do this is through the use of a Data and Safety Monitoring Board (DSMB) – a group of people who monitor the progress of a trial and review safety data in an ongoing manner. However, until recently, there’s been little guidance related to DSMB practices. In response, a group of cross-hub Clinical and Translational Science Award (CTSA) Program members have produced an online DSMB Training Manual.
The manual, which is the work of the CTSA Program Collaborative DSMB Workgroup, provides training, resources and information for Principal Investigators, DSMB members, IRB members, biostatisticians and research staff alike on how to work effectively with DSMBs.
DSMBs are typically made up of individuals who are experts on the disease or study aspect in question, such as physicians, statisticians and patient advocates – this specific expertise greatly improves the quality of the trial. But while there’s no denying the benefit of involving a DSMB, there’s been a clear lack of guidance on how to best work with them, especially when it comes to investigator-initiated studies, which are common throughout the CTSA Program.
“Unlike industry-initiated studies, investigators who run [investigator-initiated studies] don’t always have the necessary expertise to make effective safety- and data-related decisions,” said Laurel Yasko, administrative director of Operations at the University of Pittsburgh Clinical and Translational Science Institution and manual editor. “That’s why DSMB involvement is so important in these types of trials, and why our group was so compelled to create the manual.”
The DSMB Training Manual is more than just a resource for investigators, though; it also offers key guidance for those who are asked to serve on a DSMB. In addition to providing samples and templates for data and safety monitoring plans, charters, and meeting agendas, the manual provides insights to things like, ‘What sort of questions should you ask if you’re invited to sit on a DSMB?’ and ‘What are typical board member roles and responsibilities?’
The manual, which has been in the works since 2014, is a collaborative project by experts in data and safety monitoring of research studies from nine CTSA Program hubs. As a result of working with such a broad group, the manual contributors reduced the risk of it being specific to one institution.
“By combining expertise from so many different organizations, we were able to truly address universal concepts and make a resource that’s applicable to a wide range of scientists and researchers,” said Tamsin Knox, associate director of Regulatory Affairs at Tufts Clinical and Translational Science Institute and fellow manual editor. “We learned a lot from each other through this collaboration, and we’re excited to continue working together to expand available training in the future.”
To learn more, or to download the free DSMB Training Manual, visit Tufts website.
The following individuals contributed to the creation of the DSMB Training Manual:
- Barbara Hammack, PhD, Editor (University of Colorado, Denver, Colorado Clinical and Translational Sciences Institute)
- M.E. Blair Holbein, PhD, BACP, Editor (University of Texas, Southwestern Medical Center at Dallas, Center for Clinical and Translational Sciences)
- Tamsin A. Knox, MD, MPH, Editor (Tufts University, Tufts Clinical and Translational Science Institute)
- Laurel Yasko, MPPM, RN, CCRC, Editor (University of Pittsburgh, Clinical and Translational Science Institute)
- Frederick W. Luthardt, DBe, MA, Contributor (Johns Hopkins University, Institute for Clinical and Translational Research)
- Ann J. Melvin, MD, MPH, and Jason Malone, MPA, Contributors (University of Washington, Institution of Translational Health Sciences)
- Nancy Needler, BS, CCRC, Contributor (University of Rochester, Clinical and Translational Science Institute)
- Marie Rape, RN, BSN, Contributor (University of North Carolina, North Carolina Translational and Clinical Sciences Institute)
- Carson Reider, PhD, Contributor (The Ohio State University, Center for Clinical and Translational Science and The Neuroscience Research Institute)
- Susan Sandusky, BA, Contributor (University of Pittsburgh Clinical and Translational Science Institute)
Posted: August 20, 2018