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|Title:||USE OF OPERATIONAL AND DECISIONAL APPROACHES IN CLINICAL PHARMACOLOGY RESEARCH TO OPTIMIZE CLINICAL TRIAL MANAGEMENT DESIGN AND ANALYSIS|
|Abstract:||This thesis comprises of three different domains of rational approaches in clinical trial newlinemanagement woven together by the idea that Critical Path Analysis, Meta analysis and newlineInterim Analysis which influence organizational operations and decision making strategies in newlinethe pharmaceutical industry, i.e. an essential ingredient of clinical trial studies. This is a newlinemodular thesis in which three modules of rational approaches to clinical trials have been laid newlineout serially. newlineIn the first module, we described the application of Critical Path Analysis in newlinedevelopment of new clinical trial projects to avoid complexity in schedules, enhancement of newlineproject control and handling project constraints for optimized decision. newlineIn the second module, we concentrate on how several things be considered while newlineselecting a hypothesis and study design. There should be some specific knowledge to be newlinegained from Meta Analysis of several projects aimed to explore the same clinical trial goals. newlineSome reasons to perform Meta-Analyses are to establish the presence of an effect, determine newlinethe magnitude of an effect such that it resolves the differences in a literature if any and newlinedetermine important moderators of an effect. newlineAt the end and the third module of this thesis examines monitoring of response newlinevariables to predict the final outcome through an impartial and statistically valid approach, newlineviz. Interim Analysis. Such interim analysis and monitoring of specially sizeable (and/or newlinerisky) trials keep the decision process free of conflict of interest while considering cost, newlineresources and meaningfulness of the overall project. Whenever necessary such interim newlineanalysis can also call for potential termination or appropriate modification in sample size, newlinestudy design and even an early declaration of success. newline|
|Appears in Departments:||Institute of Pharmacy|
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