The central goals of this core are: A) ethical and scientifically rigorous conduct of clinical trials;B) facilitate the integration of clinical trials that are currently ongoing, or are in development, and projects of this SPORE; C) to support the implementation of clinical trials and the process of patient enrollment, data collection, and satisfy regulatory requirements associated with trials that are part of this SPORE as well as new clinical trials that take advantage of molecular knowledge generated by this SPORE;D) to facilitate the integration of novel therapeutic agents into the overall research goal of this SPORE;E) to participate (with Core A) in design of the database structures necessary for the efficient and accurate computerization of data for the studies in each project;and to do this in a manner that protects participants'privacy and protects against data loss and/or corruption;F) to monitor the projects'data in real time as they are accumulated, identifying potential problems, and discussing them with the project leaders as appropriate and initiating remedial action when necessary;G) To ensure that all institutional and federal regulatory requirements are optimally satisfied in a timely manner. H) to provide the statistical expertise to assist investigators in the planning of research studies, including decisions on the basic study design as well as study parameters such as sample size, accrual and follow-up time, and frequency of observations;I) to perform the statistical analyses and produce data summaries as called for in the projects'study protocols, and to facilitate interpretation of results;J) to assist in the preparation of abstracts and manuscripts that will disseminate the knowledge gained through this SPORE throughout the medical community. This Core will be led jointly by Dr. George Simon, an experienced physician-researcher in the Thoracic Oncology Program and Dr. Michael Schell, the Scientific Director of the Biostatistics Core at the Moffitt Cancer Center, also an experienced biostatistician especially as pertaining to the design and conduct of cancer clinical trials, with special emphasis on lung cancer and Dr. Gerold Bepler who is the P.I. of this SPORE These investigators have a lengthy and productive history of prior clinical investigations and statistical analyses. Dr. Simon will focus his attention on issues of clinical trial logistics such as preparation of study protocols, patient enrollment and retention, and satisfaction of regulatory requirements, supervise the clinical trials coordinators, be a resource to the individual project leaders in the implementation of their clinical trials and prepare for and respond to the Cancer Center mandated audits. In addition, he along with Dr. Bepler will conceptualize new studies that use the new knowledge generated by the SPORE's projects. Dr. Schell will focus on statistical design of SPORE studies;and production of statistical analyses and summaries. Dr. Bepler will provide consultations on an as needed basis to the investigators of this core
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