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Zalicus AŞ Message Board

  • wildbullus wildbullus Jul 4, 2013 9:17 PM Flag

    Can Zalicus show preliminary Z160 P2a trial result?

    Some other company can show preliminary result while the trial still going on.

    Can Zalicus show preliminary result for part of the Z160 P2a trial? So far some patients recruited earlier must finish the six weeks study, Zalicus can collecting the data and do a statistic analysis?

    Sentiment: Hold

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    • Wildb, our best option is for Dr. Corrigan to petition NASDAQ using their established protocol.

      Sentiment: Strong Buy

    • Zalicus can show the preliminary result at JMP conference in August?

      Sentiment: Hold

      • 1 Reply to wildbullus
      • No.

        Interim analyses and their interpretations need to be done carefully and judiciously. The decision to
        conduct an interim analysis should be based, first and foremost, on sound scientific reasoning that is guided by clinical and statistical integrity, standard operating practices for interim analyses, and
        regulatory concerns. Such a decision must not and should not be based on natural tendencies toward administrative and/or academic curiosity. The statistical guidelines governing the conduct of any interim analyses should be clearly outlined in the protocol when interim analyses are prospectively planned. Naive and inappropriate uses of interim analysis in forms such as administrative analysis, interim analysis for safety, and/or sample size adjustment in confirmatory clinical trials may introduce bias into the trial and reduce the credibility of the results. They should, therefore, be used with caution. If such analyses involve formal significance testing of relative treatment group differences, adjustment of p-values should be addressed. Currently, there are no standard statistical strategies for the adjustment of p-values due to unplanned interim analyses. Therefore, unplanned interim analyses should be avoid ed as they can flaw the results of a well-planned clinical trial. If it is suspected that unplanned interim analyses may be necessary, contingency plans for such analyses should be laid out in the protocol. When such (unplanned interim) analyses are actually carried out, the reasons why they are necessary, and the steps taken to minimize bias must be carefully explained in the study report in order to protect the integrity of the trial.More statistical research and guidance are needed in this area. Both the recently released ICH
        document, and the 'soon-to-be released' FDA Office of Biostatistics statistical guidance document
        discuss statistical guidelines on the use of a variety of clinical trial monitoring practices including

        Sentiment: Strong Buy