Clinical Trials and Comparative Effectiveness Research

In collaboration with the Office of Research Services (ORS) and Research Information Technology, The International Center for Health Outcomes and Innovation Research (InCHOIR) within the Department of Health Evidence and Policy offers expertise in the design, conduct, and analysis of randomized trials of novel interventions, ranging from proof-of-concept (Phase I and II) to large-scale multicenter clinical trials and comparative effectiveness research. This team provides consultation, support, and services in the following areas:

• Design of comparative effectiveness trials and randomized trials of novel interventions, including selection and measurement of endpoints (e.g., functional status, quality of life, economic endpoints), choice of comparison arms, standardization of interventions, definition of the appropriate patient population, and refinement of recruitment strategies
• Statistical design and analysis of trials employing optimal multistage designs in Phase I and II studies, sample size calculations, adaptive trial designs, and implementation of novel Bayesian approaches
• Creation of study documentation, including protocols, case report forms, and manuals of operations/procedures
• Informatics, including study websites and the design of secure, centralized, electronic data capture (EDC) systems that are HIPAA- and FDA-compliant, that accommodate a broad range of work flows dictated by study design
• Selection and management of core labs, medical monitors, and oversight committees such as Data Safety Monitoring Boards DSMBs and event adjudication committees
• Regulatory affairs, including IND and IDE submissions, Food and Drug Administration (FDA) reporting, and Pre-Market Approval (PMA) development
• Data integrity and quality assurance, including remote (electronic) and on-site source documentation auditing.

For more information or to schedule a meeting, e-mail research.services@mssm.edu.