The primary objective of the Biostatistics and Clinical Trials Management Core is to provide assistance to theprojects in the design, conduct, and analysis of the clinical trials proposed in the PO1 and to assist theprojects in the biostatistical design and analysis of laboratory studies. Specifically, this resource will provideassistance with translating laboratory findings into questions answerable within a clinical trial, clinical trialdevelopment, 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 forthe clinical trials. The core will assure the safety and confidentiality of the data within a pre-existing relationaldatabase.The Core Director will be Steven Piantadosi, M.D., Ph.D. Dr. Piantadosi is a Professor of Oncology andholds joint appointments in the Departments of Biostatistics and Epidemiology in the Johns HopkinsBloomberg School of Public Health. Dr. Piantadosi will focus his efforts on assisting the laboratoryinvestigators in the design and analysis of their preclinical studies and in translating these preclinical studiesinto clinical trials by providing state of the art experimental designs and analyses through statisticalconsultation and collaboration with respect to methodology, feasibility, safety monitoring, analysis andreporting of clinical trials and laboratory studies.The Core Co-Director will be Carol Ann Huff. Assistant Professor of Oncology. Dr. Huff is a clinicalinvestigatory who is experienced in clinical research management. Dr. Huffs effort will be focused onregulatory approval and protocol conduct including research nursing and data management oversight withthe goal of providing quality controlled data in a systematic, efficient and coordinated fashion so thataccurate, complete, validated databases are available.
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