Biostatistics and Study Design Work Group

Pragmatic clinical trials require particular design considerations, including input from stakeholders, heterogeneity of patient populations to enhance generalizability, treatments that are readily applied in the clinical setting, and evaluation of clinically impactful outcomes. Sensitivity to biases in recruitment techniques, sampling approaches, and randomization methods is important in pragmatic studies of non-pharmacological approaches to pain management. The Biostatistics and Study Design Work Group focuses on the efficient conduct of pragmatic clinical trials by developing methodological standards for their design and implementation.

Chair or Co-Chairs:

James Dziura

Tassos Kyriakides

Project Manager:

Mary Geda

Work Group Goals

Provide guidance on methodological standards in the design and implementation of non-pharmacologic pragmatic trials of pain management.
Collaborate with demonstration projects during planning and execution phases to ensure efficient and robust study design and analysis plans.
Review proposed data processes to ensure that collection of all required individual-level data is feasible and well described.
Work with collaborators, investigators and academic institutions to collate and disseminate statistical and methodological issues arising from review of the demonstration projects.
Facilitate methodological work in response to issues identified through demonstration project review.

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).

Supporting Research in Pain Management for Veterans and Military Service Members

Supporting Research in Pain Management for Veterans and Military Service Members