The Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) Data Safety Monitoring Board (DSMB) is charged with protecting the safety and welfare of subjects participating in CFFT-sanctioned clinical trials 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 CFFT DSMB very effective at monitoring CF clinical trials and protecting CF research participants as new drugs are developed.
The DSMB consists of a number of experts in CF clinical care, clinical and basic science research, bioethics and biostatistics. Administrative operations are based at the University of Arizona in Tucson, under the leadership of Dr. Wayne Morgan.
Data Monitoring Committees
A Data Monitoring Committee (DMC) is a subcommittee of the DSMB formed for a particular clinical trial. The specific role of the DMC is delineated in a charter developed with the sponsor and principal investigator.
Typically, the study DMC reviews the protocol and proposed safety monitoring plan before the study starts. During the study, the DMC is responsible for real-time serious adverse event monitoring and reviewing interim analyses of safety and outcomes data to ensure the continued safety, scientific validity and merit of the clinical trial.
DMCs vary in size and nature depending upon the study, but usually include three to five CF clinicians plus ad hoc members with specific expertise as required. All DMC members sign a confidentiality agreement and are aware of the critical importance of maintaining any and all information about the given study in the strictest confidence.
A DMC charter is developed by the study sponsor to clearly define the function, composition and operating expectations of the study DMC. Contact the DSMB Program Coordinator for guidelines and a standard template for DMC charter development. Statistical consultation on the charter is available from the Therapeutics Development Network (TDN) Coordinating Center.
DMC Protocol Review
To assess whether the study is designed to adequately protect patient safety 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 also are provided to the DMC.
Interim Safety Monitoring
During the study, the DMC is tasked with evaluating significant adverse events in real time and conducting interim reviews of outcome and safety data to make recommendations concerning continuation, termination or modification of the trial. Major study design modifications and/or protocol amendments must be reviewed by the DMC prior to implementation.
Although both the Therapeutics Development Network (TDN) and DSMB are sponsored by Cystic Fibrosis Foundation Therapeutics, Inc., the two entities are organizationally separate, allowing the DSMB to maintain independence and equipoise.
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For more detailed information about working with the DSMB, including a sponsor checklist, see the CFFT TDN Protocol Review and Data Safety Monitoring Processes brochure and flow chart.
Study sponsors should contact the DSMB at least six weeks in advance of submitting a protocol to the TDN. All communication to the CFFT DSMB or Data Monitoring Committees from sponsors or principal investigators should be directed through:
Miriam Hunt, Senior CFFT DSMB Program Coordinator
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