“At the DSMB program, one of our core missions is to convene monitoring committees that not only possess deep expertise in their clinical fields but also have a keen understanding of clinical trial conduct. This dual insight is the cornerstone of our approach, ensuring the highest standards of safety and integrity in the trials we oversee.”
Ludovic Trinquart, PhDDSMB Director
Strengthening Clinical Trials Through Expert Monitoring
Clinical trials are the cornerstone of advancing medical research and patient care. The Tufts CTSI Data and Safety Monitoring Board (DSMB) Program stands at the forefront of ensuring that investigator-initiated trials are conducted with the utmost attention to safety and integrity. All clinical trials require some level of monitoring and the intensity of monitoring should be commensurate with risks and the complexity of the trial. Our mission is to support investigators in overseeing the progression of their clinical trial, identifying risks, and safeguarding participants’ health and safety.
Why We Exist
The DSMB Program is an essential component of the clinical trial process. We exist to ensure the safety of trial participants and the validity and integrity of the data collected. Through monitoring and comprehensive data review, we facilitate the conduct of clinical trials, preemptively addressing potential issues and ensuring that clinical trials adhere to the highest standards of research ethics and scientific excellence.
What We Do
We provide expertise on data and safety monitoring processes of clinical trials. From initial consulting to full clinical trial monitoring, our team supports researchers and research staff, as well as IRBs and Human Research Protection programs. We specialize in risk determination and appropriate level of monitoring, development and re-writing of Data and Safety Monitoring Plans (DSMP) and DSMB charters, and organizing and running DSMBs. We also help with the development of adequate definitions and collection methods of adverse events and serious adverse events. We provide support with grant proposals ensuring compliance with NIH and other sponsors’ policy for Data and Safety Monitoring. Our aim is to tailor each DSMB to the specific needs of the trial, ensuring a fit-for-purpose approach that aligns with the unique demands of the research. We also are responsible for the Cancer Center standing DSMB.
Contributing to Tufts CTSI’s Mission
By ensuring the integrity of clinical trials, the DSMB Program directly contributes to the overarching mission of the Clinical and Translational Science Institute (CTSI). Our work enables clinical trialists to protect the safety of clinical trial participants and to produce credible and high-quality data. We are committed to the advancement of clinical research, supporting the CTSI in its goal to translate laboratory findings into treatments for patients.
Who is Eligible?
Any investigator at any institution is eligible for the DSMB program. Some services are offered at no cost to investigators at institutions affiliated with Tufts CTSI; other services are offered for a fee and are available to anyone (the rate may vary).
Sign up for a virtual drop-in session.
Core Functions and Services
Risk Determination & Monitoring Recommendations: We assess potential risks in clinical trials and provide tailored monitoring strategies to mitigate them.
Data and Safety Monitoring Plan Development: Developing detailed DSMPs, ensuring that each plan is robust and compliant with regulatory standards.
Adverse Event Definitions: We help determine what constitutes an adverse event or serious adverse event within the context of your study, ensuring clear guidelines for data collection and reporting.
Event adjudication: We provide risk-based recommendations with regards to Clinical Endpoint Committees.
Grant Proposals: We assist in creating a plan for a DSMB within your grant proposals to secure necessary funding.
DSMB Set-Up and Management Activities: From initial setup to full operationalization, we help convening an effective DSMB tailored to your trial’s needs, we provide set-up activities (e.g. development of DSMB charter) and per meeting activities, and we support the coordination between the DSMB and the DCC
Maintaining DSMB Independence: We ensure that each DSMB operates with full independence from the influence of study sponsors or investigators, upholding the objectivity and integrity of monitoring processes.
DSMB Training: We support future DSMB members with training modules designed to equip professionals with the knowledge and skills necessary for effective data and safety monitoring. In particular, we provide an online DSMB training manual developed by the CTSA Collaborative DSMB Workgroup.
FAQ
Is there any cost for using your services?
Brief consultations are provided at no cost to investigators. Sign up for a virtual drop-in session.
For other services, charges apply. Tufts CTSI-affiliated researchers will receive a discounted rate, while non-affiliates will receive our standard rate.
Contact
Ludovic Trinquart, PhD: Center Director, Ludovic.Trinquart@tuftsmedicine.org
Michelle Lee-Bravatti, MSc MPH: Clinical Trial Data Manager, Michelle.LeeBravatti@tuftsmedicine.org
Ellaina Reed, BA: Project Manager, Ellaina.Reed@tuftsmedicine.org