Biostatistics and Data Management

Stanford University, Stanford CA

Investigators

Linked publications & trials

Abstract

CORE B (BIOSTATISTICS AND DATA MANAGEMENT CORE): PROJECT SUMMARY/ABSTRACT Core B which has supported the PPG for almost 30 years, consists of a Core Leader (Lu), a Core Physician leader (Lowsky), a Biostatistician (Tamaresis), a post-doctoral fellow (Bi), and a data manager (TBN), who will supervise the clinical research assistants (CRAs) and protocol coordinator (in addition to his/her PPG work) supported by the Stanford University Medical Center and other grants which provide services as needed to support the PPG aims. The leader of Core B and the biostatistician have decades of experience in medical research and especially in clinical trial design and data management work (organization, planning, management, monitoring and analysis) in collaboration with medical investigators, including many years of collective experience working with the BMT investigators. The Core B physician leader, Dr. Lowsky, has extensive experience in the development, conduct, data collection and analysis, study completion and monitoring of single center and multi-center clinical trials. The Core supports the clinical and preclinical projects and Core C in the proposal by leveraging the depth of expertise in biostatistics and data science at Stanford University to assist project investigators in all aspects of their studies. Core B meets weekly to review and plan work, often joined by other key PPG personnel. The Core staff meet monthly with all clinical research assistants, the program project PI and the other clinical investigators, to resolve difficulties and problems, for example, in data collection, data flow, definitions, electronic data collection forms design, and protocol development. Frequent ad hoc meetings between investigators and Core B members are scheduled, as needed. Each of the 5 new projects in the program project (based on experience and preparation of plans for the coming years to be supported through this program) will use about the same fraction of Core B effort (18% each) and the remainder are split between Core C (28%). The Core has 5 specific aims: 1) provide biostatistics consultation and support to the PPG project investigators in animal studies and clinical trials, 2) develop biostatistics and bioinformatics methods and tools to correlate outcome, toxicity, and efficacy, coordinating support between projects and Core C, 3) maintain all standard procedures and use the best data science practice for assuring quality of the data collected, reproducible analysis, and production of management reports, 4) aid in assembling, summarizing, and analyzing data for regulatory, operational, and scientific reporting, and 5) coordinate and consult with the hospital-supported maintainers of the BMT database. Core B is committed to active and continued participation in the PPG to help ensure that project Aims are fulfilled in the most scientifically meaningful manner.