The primary objective of the Biostatistics and Clinical Trials Management Core is to provide assistance to the projects in the design, conduct, and analysis of the clinical trials proposed in the PO1 and to assist the projects in the biostatistical design and analysis of laboratory studies. Specifically, this resource will provide assistance with translating laboratory findings into questions answerable within a clinical trial, clinical trial development, regulatory assistance with IND and IRB approvals, and clinical trial conduct will be provided. The core will provide research nursing, data management, adverse event reporting, and trial monitoring for the clinical trials. The core will assure the safety and confidentiality of the data within a pre-existing relational database. The Core Director will be Steven Piantadosi, M.D., Ph.D. Dr. Piantadosi is a Professor of Oncology and holds joint appointments in the Departments of Biostatistics and Epidemiology in the Johns Hopkins Bloomberg School of Public Health. Dr. Piantadosi will focus his efforts on assisting the laboratory investigators in the design and analysis of their preclinical studies and in translating these preclinical studies into clinical trials by providing state of the art experimental designs and analyses through statistical consultation and collaboration with respect to methodology, feasibility, safety monitoring, analysis and reporting of clinical trials and laboratory studies. The Core Co-Director will be Carol Ann Huff. Assistant Professor of Oncology. Dr. Huff is a clinical investigatory who is experienced in clinical research management. Dr. Huffs effort will be focused on regulatory approval and protocol conduct including research nursing and data management oversight with the goal of providing quality controlled data in a systematic, efficient and coordinated fashion so that accurate, complete, validated databases are available.
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