4 OVERALL PROGRAM CRITIQUE 4 PROGRAM LEADERSHIP 4 PROGRAM AS AN INTEGRATED EFFORT 4 PROJECT AND CORE SUMMARIES OF DISCUSSION 5 COLLABORATING INSTITUTIONS 7 PROTECTION OF HUMAN SUBJECTS (Resume) 8 VERTEBRATE ANIMALS 8 ADDITIONAL REVIEW COSIDERATIONS (Resume) 8 INDIVIDUAL PROJECTS AND CORES 9 PROJECT 1: INNOVATIVE CLINICAL TRIAL DESIGN AND ANALYSIS 9 PROJECT 2: METHODS FOR MISSING AND AUXILIARY DATA IN CLINICAL TRIALS 14 PROJECT 3: METHODS FOR POST MARKETING SURVEILLANCE AND COMPARATIVE EFFECTIVENES RESEARCH 24 PROJECT 4: METHODS FOR PHARMACOGENOMICS AND INDIVIDUALIZED THERAPY TRIALS 30 PROJECT 5: METHODS FOR DISCOVERY AND ANALYSIS OF DYNAMIC TREATMENT REGIMES 36 CORE A: ADMINISTRATIVE CORE 47 CORE B: DATA COMPILATION CORE 49 CORE C: COMPUTATIONAL RESOURCE AND DISSEMINATION CORE 53 COMMITTEE BUDGET RECOMMENDATIONS 58 SPECIAL EMPHASIS PANEL ROSTER DESCRIPTION (provided by applicant): The overall scientific goal of this ambitious program project is to develop highly innovative methods for cancer clinical trials that can hasten successful introduction of effective new therapies into practice. The method of approach is to leverage recent advances in statistical and computational science to create new clinical trial designs and data analysis tools that resolve many of the key scientific limitations of current clinical trial methodology. The projects focus on practical design and analysis problems in Phase II and Phase 111 clinical trials, the problem of missing data and efficient use of prognostic information, postmarketing surveillance and comparative effectiveness research using clinical trial data, pharmacogenetics and individualized therapies, and the potential of dynamic treatment regimens to improve cancer treatment. The proposed clinical trial design and analysis innovations have the potential to change the prevailing clinical trial paradigm and greatly increase the rate of discovery and translation of new treatments into clinical practice. Our multi-institutional approach includes an effective and energetic process for intense, coordinated implementation, communication and dissemination of results, including developing new software for practical implementation of the newly developed methods. Our comprehensive and novel approach will lead to significant improvements in cancer clinical trial practice that will result in improved health of cancer patients.
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