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  • Risk-based quality management in clinical trials, draft

    The aim of this paper is to describe the concept of risk based quality management in the setting of clinical research. Several related approaches have been described that focus on particular aspects of the research. The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.

    EMA - European Medicines Agency (Statistics) - Tue, 6 September 2011
    http://www.ema.europa.eu

  • "Flogging dead horses": evaluating when have clinical trials achieved sufficiency and stability? A case study in cardiac rehabilitation

    Most systematic reviews conclude that another clinical trial is needed. Measures of sufficiency and stability may indicate whether this is true. The objectives of the review was to show how evidence accumulated on centre-based versus home-based cardiac rehabilitation, including estimates of sufficiency and stability. The evidence points to a relatively small effect difference which was stable but not sufficient in terms of the suggested thresholds. Sufficiency should arguably be based on substantive significance and decided by patients. Research on patient preferences should be the priority. Sufficiency and stability measures are useful tools that need to be tested in further case studies.

    Trials Journal (Statistics) - Mon, 21 March 2011
    http://www.trialsjournal.com/
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