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tandfonline.com – Inference and Decision Making for 21st-Century Drug Development and Approval

tandfonline.com har udgivet en rapport under søgningen “Teacher Education Mathematics”:

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.

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Troels Gannerup Christensen

Jeg er ansat som adjunkt hos Læreruddannelsen i Jelling, hvor jeg underviser i matematik, specialiseringsmodulet teknologiforståelse, praktik m.m. Jeg har tidligere været ansat som pædagogisk konsulent i matematik og tysk hos UCL ved Center for Undervisningsmidler (CFU) i Vejle og lærer i udskolingen (7.-9. klasse) på Lyshøjskolen i Kolding. Jeg er ejer af og driver bl.a. hjemmesiderne www.lærklokken.dk og www.iundervisning.dk, ggbkursus.dk og er tidligere fagredaktør på matematik på emu.dk. Jeg går ind for, at læring skal være let tilgængelig og i størst mulig omfang gratis at benytte.

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