“At the Center for Clinical Trials, our aim is to support investigators by facilitating and advancing the use of complex or novel clinical trial designs. Our expertise is not just in navigating the complexities of trial design but in ensuring every clinical trial we support can achieve its fullest potential.”

Ludovic Trinquart, PhD
Center Director

Empowering Clinical Trialists with Advanced Methodologies

In the rapidly evolving landscape of clinical research, the Center for Clinical Trials at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center and Tufts CTSI pioneers the application of innovative clinical trial designs. Our mission is to enhance investigator-initiated trials by offering cutting-edge expertise in trial design, for example adaptive designs, Bayesian methods, personalized n-of-1 trials, group-randomized trial methods (such as stepped-wedge trials), or trials for adaptive interventions (SMART). By facilitating complex and novel approaches, we aim to advance the scope and efficiency of clinical trials.

Why We Exist

The Center for Clinical Trials is founded on the principle that adopting certain complex or novel clinical trial designs can significantly impact the success and translational potential of research. We provide leadership in statistical methodology, ensuring that trials are not only well-designed but also rigorously monitored for quality and integrity.

What We Do

We collaborate with clinical trial investigators on grant proposal development. We provide statistical leadership throughout clinical trial design, planning, execution, monitoring, analysis, and dissemination. We also provide expertise on data systems, randomization, data management, quality control and assurance. The Center for Clinical Trials serves as Data Coordinating Center for multi-site trials. Through our work, we enable investigators to focus on groundbreaking research while we ensure the methodological and operational foundations are solid and innovative.

Contributing to Tufts CTSI’s Mission

At the heart of the Center for Clinical Trials is a commitment to advancing clinical and translational science in alignment with the mission of Tufts CTSI. By fostering innovative clinical trial designs and providing comprehensive clinical trial support, the Center supports trialists to translate novel findings into effective treatments and interventions. Our dedication to advancing statistical methodology, enhancing data quality, and ensuring rigorous trial oversight strengthens the foundation of translational science. Through collaboration and leadership, the Center enhances the capacity of Tufts CTSI to impact health outcomes.

Core Functions and Services

Innovative Clinical Trial Design: Specializing in advanced designs – such as adaptive, Bayesian, n-of-1, or group-randomized methods – to address complex research questions.

Grant Development Support: Collaborating with trialists on integrating advanced trial designs into their grant proposals.

Statistical Methodology Leadership: Offering expertise in statistical analysis plans tailored to innovative trial designs

Data Management Support:  Developing state-of the-art Electronic Data Capture systems. Each data management system is designed to optimize the efficiency of the clinical trial workflow. We also provide comprehensive data management, including quality control and assurance.

Study Monitoring and Coordination: Ensuring the integrity and success of clinical trials through monitoring and coordination as a Data Coordinating Center.

Consultations: Consulting on complex trial designs, statistical analysis, and regulatory compliance to maximize research impact and efficiency.

Who is Eligible?

We collaborate with all investigators, with priority given to those affiliated with Tufts CTSI.

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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

Submit a service request.