ABSTRACT
This chapter emphasizes the integration of clinical data management and statistical concepts and methodology into the clinical development program. Consideration is given to program organization, planning and execution, medical objectives, and data management procedures, all of which impact directly on statistical considerations. Conceptualization, organization, and execution of clinical trials are primary responsibilities of the medical monitor. In addition to statistical design, analysis, these activities include development and modification of software for data collection, storage and retrieval, data encoding, entry, data base validation and generation of listings, reports and summaries. The chapter addresses the important statistical concepts which must be incorporated into the protocol. Data presentation, baseline variables and other potential sources of bias, hypothesis testing, estimation, patients who discontinue study, hypotheses of no difference, problems with multiplicity and periodic analysis, and inferences and conclusions are discussed below. Data presentation can be considered to contain five levels: case report forms, computer data files, data listings, summaries, and statistical analyses.
