Noninferiority Testing in Clinical Trials: Issues and by Tie-Hua Ng

By Tie-Hua Ng

Take Your NI Trial to the following Level

Reflecting the huge examine on noninferiority (NI) designs from the prior 15 years, Noninferiority checking out in medical Trials: concerns and Challenges explains the right way to pick out the NI margin as a small fraction of the healing influence of the energetic regulate in a scientific trial. Requiring no earlier wisdom of NI trying out, the e-book is well obtainable to either statisticians and nonstatisticians fascinated about drug development.

With over two decades of expertise during this quarter, the writer introduces the elemental parts of the NI trials separately in a logical order. He discusses matters with estimating the impression measurement in line with ancient placebo keep an eye on trials of the lively keep an eye on. The e-book covers basic techniques on the topic of NI trials, akin to assay sensitivity, fidelity assumption, discounting, and upkeep. It additionally describes sufferer populations, three-arm trials, and the equivalence of 3 or extra groups.

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In: Crowley J ed. Handbook of Statistics in Clinical Oncology, New York: Marcel Dekker, 173–187. Spiegelhalter DJ, and Freedman LS (1986). A Predictive Approach to Selecting the Size of a Clinical Trial Based on Subjective Clinical Opinion. Statistics in Medicine, 5:1–13. Suda KJ, Hurley AM, McKibbin T, and Motl Moroney SE (2011). Publication of Noninferiority Clinical Trials: Changes over a 20-Year Interval. Pharmacotherapy, 31(9):833–839. Temple R, (1982). Government Viewpoint of Clinical Trials.

12-EHC045-EF. Rockville, MD: Agency for Healthcare Research and Quality, June 2012. pdf (Accessed: March 1, 2014). S. Food and Drug Administration (2001a). S. Food and Drug Administration, Rockville, MD. S. Food and Drug Administration (2001b). Guidance for Industry: Acceptance of Foreign Clinical Studies. htm (Accessed: February 18, 2013). S. Food and Drug Administration (2010). Draft Guidance for Industry: Noninferiority Clinical Trials. pdf (Accessed: August 25, 2013). S. Food and Drug Administration (2012).

34 Noninferiority Testing in Clinical Trials European Medicines Agency (2005). Committee for Medicinal Products for Human Use (CHMP). Guideline on the Choice of the Non-Inferiority Margin EMEA/­CPMP/EWP/2158/99. Gülmezoglu AM, Widmer M, Merialdi M, et al. (2009). Active Management of the Third Stage of Labour Without Controlled Cord Traction: A Randomized Noninferiority Controlled Trial. com/content/6/1/2 (Accessed: March 30, 2013). Hung HMJ, Wang S-J, and O’Neill RT (2005). A Regulatory Perspective on Choice of Margin and Statistical Inference Issue in Non-Inferiority Trials.

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