Data analysis preview

This is an extremely important aspect of the trial with which the statistician has very little to do although he or she can occasionally be required to give advice regarding blinding and randomization issues. I mention it here to remind statistical readers of the arduous, essential and often complex, work carried out by others in performing experiments that statisticians have helped to design. 

At the data analysis preview it is common to update the prespecifled analysis and issue a formal statistical analysis plan. The plan gives more detail on the analysis to be conducted than can usefully be included in the protocol, e.g. precise descriptions of how variables derived from the source data are to be calculated, A key component is a full specification of the tables, listings and graphical presentations to be produced. The analysis plan is discussed and agreed by the study team. 

Many drug companies produce mock-up tables using available data based on fake treatment codes in advance of database finalization. While the actual results shown in the tables have no meaning, they can help to identify data issues and clarify the proposed presentation of the results. 

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Research on the identification of vanilloid antagonists has been pursued more intensively in industry than in academia. Thus, a SciFinder search for new chemical entities endowed with this type of activity pulled out 34 entries from the proprietary literature, and only 14 from journal articles during the period January 2004 June 2006. The patent literature can be difficult to evaluate and compare with the published data. Bioactivity is often not disclosed (or commented), and activity can be broadly claimed for a series of lead structures without specifying their optimal substitution. On the other hand, analysis of the patent literature does not only complement the published data, but also offers a preview of information that will be eventually disclosed and detailed in journals. Given the relevance of proprietary literature in the realm of vanilloids research, the main trends emerging from its analysis will be briefly summarized. 

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