Biostatistics and Study Design Work Group
The overall mission of the Biostatistics and Study Design Work Group is to support the efficient conduct of pragmatic and implementation clinical trials and to develop methodological standards for their design and implementation.
Chair or Co-Chairs:
James Dziura, MPH, PhD
Tassos Kyriakides, PhD
Project Manager:
Mary Geda, RN, MSN
Work Group Goals
- Provide guidance on methodological standards in the design and execution of nonopioid pragmatic clinical trials (PCTs) of pain management.
- Consult with demonstration projects during planning and execution phases to ensure efficient and robust study design and analysisi plans.
- Provide a forum for discussing design and analytic issues that arise in PCTs.
- Contribute to Collaboratory products (e.g. supplements, white papers) focused on study design and methodological standards.
Work Group Co-Chairs – Qualifications and Experience
James Dziura, MPH, PhD is Professor in Emergency Medicine and Biostatistics, Deputy Director of Yale Center for Analytic Science (YCAS) and Co-Director for the Biostatistics and Study Design Core for YCCI. Dr. Dziura has led statistical and data coordinating efforts for numerous clinical trials and observational studies including 5 multi-center trials from the Research Unit on Pediatric Psychopharmacology (RUPP) and Research Unit on Behavioral Interventions (RUBI) Autism networks and the Behavioral Sciences Consortium for Tourette Syndrome. He has served as the lead statistician for trials of surgical, behavioral/lifestyle (VA-WVCS) and pharmaceutical interventions. He actively participates in governance committees including steering committee for ABC-CT and operations committee for RUBI. He has served on/chaired several industry and NIH Data Safety Monitoring Boards (DSMBs), including the DAIDS Therapeutics central DSMB. Importantly, he is one of the lead statisticians on the cluster randomized STRIDE trial and serves as the unblinded statistician for reporting to the DSMB.
Tassos Kyriakides, PhD is the Director, VA Cooperative Studies Program Coordinating Center West Haven (CSPCC-WH) and Assistant Professor, Biostatistics and Yale Center for Analytic Science (YCAS). He has dual appointment with VA and Yale and is the link between VA CSPCC and YCAS. His expertise is in the design, conduct and analysis of pragmatic trials particularly in infectious disease, surgery, screening for colon cancer and PTSD; in addition, he has worked in developing and implementing risk-based monitoring plans for multi-site pragmatic trials. He has worked on numerous U.S. and international clinical trials and has served on Data Monitoring, Trial Steering and Management Committees. He provides his expertise as a statistical consultant/analyst on numerous research protocols, has been an abstract mentor for young researchers at the International AIDS Conferences since 2012, leads the VA CSPCC internship program, has served on clinical trial scientific evaluation committees (U.S. and Canada) and is a statistical reviewer for high-impact journals (Lancet Infectious Disease and the Lance Gastroenterology & Hepatology).
Working Documents & Other Information
Intraclass Correlation Coefficients for Cluster Randomized Trials with Pain Outcomes
In this working document, the Pain Management Collaboratory Biostatistics/Design Workgroup...
Read MorePrevention of Missing Data in Pragmatic Clinical Trials of Nonpharmacologic Interventions for Pain Management
PMC’s Biostatistics/Design Work Group addresses the problem of missing data...
Read MoreCovariate Adjustment in Pragmatic Randomized Clinical Trials in Pain Research
An overview of considerations for covariate-related methodological, statistical and analytical...
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