The Biostatistics Core assists clinical researchers in the development of new innovative protocols and grants at Tufts Medical Center. It also assists basic researchers at the Cancer Center in their data analysis.
It is not solely supported by the Cancer Center, but rather is a CTSI and Tufts-wide resource. In 2006 significant progress was made in integrating all clinical research services. One product of this integration is the availability of the Design and Data Resource Center for cancer researchers, both clinical and basic.
In 2006 biostatistical support for clinical research was reorganized through the creation of a Clinical Research Portal and a new Design and Data Resource Center (DDRC). The infrastructure supports for protocol development, data management and data analyses at Tufts Medical Center have been consolidated within this new structure to provide more efficient and thorough research expertise and support to clinical researchers. This new Clinical Research Portal and the DDRC draw on over 40 years of experience in supporting clinical researchers at Tufts Medical Center and Tufts University.
The objective of the DDRC component of the Tufts Translational Clinical Research Institute (TTCRI) is to substantially expand and enhance this core support for cancer center members through the Clinical and Translational Research Portal so as to increase collaboration across Tufts University and all affiliated hospitals, and to provide essential assistance to these investigators in the development, implementation, and analyses of their research studies. By providing clinicians and researchers extensive expertise in protocol development, broad unifying data capture and analysis efforts, and standardizing methodologies and protocols used in these efforts, we have improved the efficiency of basic scientific and clinical research, substantially broadened the scope of research, and working closely with the other TTCRI components, continue to increase innovative translational research across Tufts University and affiliated hospitals.
1. To implement a team-based development approach that will strengthen cancer research protocols across the range of translational research.
The goal of this aim is to provide investigators in the development of their research protocols with extensive research and scientific expertise from a board expanse of research areas and methodologies. These collaborative and interdisciplinary teams will include the primary investigators and biostatisticians, epidemiologists, computer scientists, economists, psychometricians, geographers, molecular engineers and others as needed.
2. To implement high-quality, consistent and secure data collection methods including internet-based and electronic data capture (EDC) systems.
The goal of this aim is to bring efficient and technologically advanced methods to data collection and data storage efforts integrated across the Cancer Center. These internet-based systems would increase the efficiency of these efforts while also increasing data quality and data security, and extend the opportunities for collaborative research across institutions.
3. To provide support for the analysis of research data with a broad team of cancer researchers.
The goal of this aim is to provide broad and expert data analysis support to investigators across the Tufts cancer research community. The increased analytic support will assist in removing barriers to the translational analysis of data collected in both clinical and basic science research projects.
Dr. Griffith, an Associate Professor of Medicine at Tufts University School of Medicine (TUSM), is the Director of the Biostatistics Research Center and Senior Statistician in the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center.
For the past 18 years, Dr. Griffith has provided analytic support and data oversight for clinical investigators at Tufts University and Tufts MC. Currently, Dr. Griffith is the Co-Principal Investigator of the Data Coordinating Center (DCC) for the NHLBI-funded Immediate Trial (U01HL077826), a national randomized controlled clinical trial of 15,450 subjects to test the impact of pharmacological myocardial metabolic support, in the form of intravenous glucose, insulin, and potassium for patients with acute cardiac syndromes.
The DCC for this project maintains the entire study electronic data capture (EDC) database, oversees data security and integrity, produces periodic DSMB safety analyses and reports, and performs all statistical analyses. Dr. Griffith is also the Principal Investigator for the DCC for the Nutrition and Memory in the Elderly project (RO1–AG021790), a multidisciplinary study investigating nutrition and cognition among homebound elderly, and is the Senior Statistician in the DCC for the Center for Research/Nutrition & Health among the Elderly project (P01AG023394), a project evaluating stressors and outcomes affecting the Puerto Rican community. Dr. Griffith was the Statistical Director for the GCRC, teaches in the Clinical Research Program at the Sackler School of Graduate Biomedical Sciences and is a member of the Faculty Advisory Committee, is the Statistical Editor for the journal Clinical Infectious Disease, and is a member of the Tufts Medical Center’s Scientific Review Committee and the Institutional Review Board (IRB).
Ms. Fiorino holds a bachelor degree in Computer Science as well as an associate’s degree in Allied Health. Ms. Fiorino is currently the Director of Programming and Data Management of the Division of Clinical Research Resources (DCRR).
Ms. Fiorino is also responsible for the overall management of the GCRC Informatics Core. Her responsibilities include server management, both web and MS SQL, CAMP and ARP support, hardware and software tracking, hardware and software purchasing, education in data management for investigators and their staff, protocol assessment of Informatics needs and the collaboration between the GCRC and the institution.
Dr. Terrin is an Associate Professor in the Tufts University School of Medicine and at the Sackler School of Graduate Biomedical Sciences. She is a member of the Cancer Center, and participates in the Measurement, Outcomes, and Biostatistics Program. She is a Senior Statistician in the Institute for Clinical Research and Health Policy Studies and is on the staff of the Center for Clinical Evidence Synthesis.
Dr. Terrin is also the Senior Statistician for the General Clinical Research Center where she has worked extensively with the development of a wide range research protocols. Her methodological research experience includes the areas of meta-analysis, publication bias, predictive modeling, model performance, time series, long memory processes, and applied and theoretical probability.
Dr. Terrin teaches biostatistics and meta-analysis and mentors clinical research fellows in the Clinical Research Program at the Sackler School of Graduate Biomedical Sciences. She currently serves on the Healthcare Quality and Effectiveness Research study section of the AHRQ.
Robin Ruthazer, MPH. Ms. Ruthazer is an Assistant Professor of Medicine at Tufts University School of Medicine with extensive experience in providing statistical support to clinical researchers.
Dr. Peter is an Assistant Professor of Medicine in the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center. Her interests include assessment of genetic impact on the total variance of complex traits, and evaluation of the role of gene polymorphism in diseases with a complex pattern of inheritance. Her major areas of expertise are quantitative genetics, association and linkage studies, and bioinformatics.
Dr. Peter recently served as the genetic epidemiologist on a SCOR grant studying the involvement of estrogen related genes upon cardiovascular responses in the Framingham Heart Study cohort. She is also an active collaborator with numerous groups at Tufts University.
Since 2001, Dr. Gao has worked closely with Ms. Fiorino and Dr. Hibberd as the Senior Systems Analyst for the General Clinical Research Center (GCRC). He holds a degree in Computer Science along with industry certificates in both software development and database administration. Dr. Gao has created numerous internet-based databases for clinical researchers using the GCRC.
Dr. Yang is a Senior Software Engineer with extensive experience in web and window applications including analyzing, architecting, designing, coding, testing, site management, and reporting.
Mr. Rui is a staff programmer with extensive experience in application development with ASP, Vbscript, Java, SQL, XML, Oracle, Sybase, and database interfaces. He also has experience in working with clinical research web-based databases as well as thermal instrumentation design and dynamic analyses.
Ms. Lapitsky is a Project Director with the Tufts Medical Center DDRC with extensive experience in supporting clinical studies. Her roles include designing case-report forms, developing manuals of operations, data management, overseeing data collection, coordinating data query requests with sites, assisting with adverse event coding, database locking, and statistical programming and analytic support.
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