Tracy Nolen, DrPH - Project Director and Principal Investigator
Dr. Tracy Nolen is a senior research statistician with more than 16 years of experience providing and managing analytic support for observational studies and clinical trials funded by commercial pharmaceutical and device companies, the Department of Defense (DoD), Department of Veteran Affairs (VA), and the National Institutes of Health (NIH). Dr. Nolen holds a Doctorate of Public Health degree in Biostatistics from the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health and a master’s degree in Statistics from North Carolina State University. She specializes in the design, set-up, operation, analysis as well as scientific and regulatory reporting of clinical trials. Her statistical experience includes causal inference in observational and randomized trials settings; alternative study designs including adaptive dose finding designs and adaptive randomization algorithms; and the use of various statistical methods (e.g., regression analysis, including generalized linear models; longitudinal data analysis, including generalized estimating equation (GEE) and mixed models; survival analysis; nonparametric analysis; dose-proportionality analysis). She is a PASA Data Coordinating Center Project Director and Principal Investigator.
Rick Williams, PhD - Co-Principal Investigator
Dr. Rick Williams is a fellow of the American Statistical Association (ASA) with more than 35 years of experience in medical and epidemiological research. He has led eight major multisite research projects coordinating the efforts of dozens of research sites across the US. He designs and leads population surveys, observational studies, and randomized clinical trials. He frequently conducts workshops and training classes on the use of statistical analysis methods for cluster-correlated, longitudinal, or repeated measures data, such as generalized estimating equations for marginal models, hierarchical linear and nonlinear mixed models, and multilevel models. He has also led the selection and implementation of data capture and data management systems for clinical studies at RTI International. He holds a Ph.D. in Biostatistics with specialization in Epidemiology. Dr. Williams is the PASA Data Coordinating Center Co-Principal Investigator.
Meg Crawford – Clinical Research Manager
Meg Crawford is a research clinical studies specialist and manager in the Center for Clinical Research Network Coordination at RTI International. She has more than 15 years of experience managing clinical trials in multi-site networks, is certified as a clinical research professional, and is trained in good clinical practices. Ms. Crawford serves as the clinical research manager on the Pharmacotherapies for Alcohol and Substance Abuse Consortium (PASA). Her responsibilities include developing protocols, study manuals, and informed consent documents; developing or monitoring case report forms; reviewing adverse event experience reports; and ensuring protection of subjects and subjects’ rights through institutional review board relations. Ms. Crawford’s responsibilities also include budget development, report preparation, education and protocol training of other research professionals, project administration, and research project audits.