Providing an Extra Level of Protection
The highest priority of every
The Cystic Fibrosis Foundation provides an additional layer of protection for every CF clinical trial by funding a Data Safety Monitoring Board (
Maintaining a Core of Expertise
The DSMB is charged with protecting the safety and welfare of people participating in clinical trials sanctioned by the Therapeutics Development Network (TDN) and ensuring the scientific integrity of those trials.
Many of the risks for people with CF who participate in clinical trials are inherent to the disease, and thus are shared across different clinical trials. Maintaining a core of expertise specifically related to CF makes the DSMB very effective at monitoring CF clinical trials and protecting CF research participants as new drugs are developed.
Although both the TDN and DSMB are sponsored by the CF Foundation, the two entities are organizationally separate from each other and the Foundation.
The CF Foundation is the only voluntary health organization to organize a DSMB whose members are experts in CF and are not involved in any way with the trial, the
Data Monitoring Committees
A Data Monitoring Committee (DMC) is a subcommittee of the DSMB that is formed for a particular clinical trial. The specific role of the DMC is delineated in a charter developed with the sponsor and
The DMC for a clinical trial reviews the
DMCs vary in size and nature depending upon the study, but usually include CF community members, three to five CF clinicians, a biostatistician, plus ad hoc members with specific expertise as required. All DMC members sign a
A DMC charter is developed by the study sponsor to clearly define the function, composition, and operating expectations of the study's DMC. If you have questions about the guidelines and standard template for DMC charter development, contact the DSMB Program Coordinator, Clara Ehrman, at email@example.com. Statistical consultation on the charter is available from the TDN Coordinating Center.
DMC Protocol Review
To assess whether the study is designed to adequately protect the safety of participants and data quality, the DMC reviews the protocol, draft DMC charter, investigator brochure, and any other relevant information on the study drug prior to study initiation. To help avoid redundancy or any discrepancies, the critique and ratings from the TDN protocol review process are also provided to the DMC.
Interim Safety Monitoring
During the study, the DMC is responsible for evaluating significant adverse events in real time and conducting interim reviews of
Working with the DSMB: Getting Started
For more detailed information about working with the DSMB, see the TDN Protocol Review and Data Safety Monitoring Processes brochure, flow chart, and sponsor checklist.
Study sponsors should contact the DSMB at least six weeks in advance of submitting a protocol to the TDN.
Any questions or comments about the DSMB should be directed to DSMB Program Coordinator, Clara Ehrman, at 520-626-6754 or firstname.lastname@example.org.