The central goals of this core are: A) ethical and scientifically rigorous conduct of clinical trials; B) facilitatethe 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, andsatisfy regulatory requirements associated with trials that are part of this SPORE as well as new clinical trialsthat take advantage of molecular knowledge generated by this SPORE; D) to facilitate the integration ofnovel therapeutic agents into the overall research goal of this SPORE; E) to participate (with Core A) indesign of the database structures necessary for the efficient and accurate computerization of data for thestudies in each project; and to do this in a manner that protects participants' privacy and protects againstdata loss and/or corruption; F) to monitor the projects' data in real time as they are accumulated, identifyingpotential problems, and discussing them with the project leaders as appropriate and initiating remedial actionwhen necessary; G) To ensure that all institutional and federal regulatory requirements are optimallysatisfied in a timely manner. H) to provide the statistical expertise to assist investigators in the planning ofresearch studies, including decisions on the basic study design as well as study parameters such as samplesize, accrual and follow-up time, and frequency of observations; I) to perform the statistical analyses andproduce data summaries as called for in the projects' study protocols, and to facilitate interpretation ofresults; J) to assist in the preparation of abstracts and manuscripts that will disseminate the knowledgegained through this SPORE throughout the medical community. This Core will be led jointly by Dr. GeorgeSimon, an experienced physician-researcher in the Thoracic Oncology Program and Dr. Michael Schell, theScientific Director of the Biostatistics Core at the Moffitt Cancer Center, also an experienced biostatisticianespecially as pertaining to the design and conduct of cancer clinical trials, with special emphasis on lungcancer and Dr. Gerold Bepler who is the P.I. of this SPORE These investigators have a lengthy andproductive history of prior clinical investigations and statistical analyses. Dr. Simon will focus his attention onissues of clinical trial logistics such as preparation of study protocols, patient enrollment and retention, andsatisfaction of regulatory requirements, supervise the clinical trials coordinators, be a resource to theindividual project leaders in the implementation of their clinical trials and prepare for and respond to theCancer Center mandated audits. In addition, he along with Dr. Bepler will conceptualize new studies thatuse the new knowledge generated by the SPORE's projects. Dr. Schell will focus on statistical design ofSPORE studies; and production of statistical analyses and summaries. Dr. Bepler will provide consultationson an as needed basis to the investigators of this core
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