By Shein-Chung Chow
In scientific trial perform, arguable statistical matters unavoidably ensue whatever the compliance with sturdy statistical perform and reliable scientific perform. yet via choosing the factors of the problems and correcting them, the research goals of medical trials will be larger accomplished. debatable Statistical concerns in scientific Trials covers typically encountered debatable statistical matters in medical trials and, each time attainable, makes concepts to solve those difficulties. The e-book specializes in matters taking place at numerous levels of scientific learn and improvement, together with early-phase medical improvement (such as bioavailability/bioequivalence), bench-to-bedside translational study, and late-phase medical improvement. a variety of examples illustrate the influence of those matters at the evaluate of the protection and efficacy of the attempt remedy less than research. the writer additionally bargains thoughts relating to attainable resolutions of the issues. Written by means of one of many preeminent specialists within the box, this e-book offers an invaluable table reference and state-of-the paintings exam of troublesome matters in medical trials for scientists within the pharmaceutical undefined, medical/statistical reviewers in govt regulatory organisations, and researchers and scholars in academia.
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Extra info for Controversial Statistical Issues in Clinical Trials (Chapman & Hall CRC Biostatistics Series)
Principle 10: Cost Effectiveness—Resources must be effectively used. Principle 11: Relevance—European statistics must meet the needs of users. Principle 12: Accuracy and Reliability—European statistics must accurately and reliably portray reality. Principle 13: Timeliness and Punctuality—European statistics must be disseminated in a timely and punctual manner. Principle 14: Coherence and Comparability—European statistics should be consistent internally, over time and comparable between regions and countries; it should be possible to combine and make joint use of related data from different sources.
On the other hand, if a one-sided test is used, the level of proof required is 1 out of 20. It turns out that a one-sided test allows more ineffective drugs to be approved because of chance as compared to the two-sided test. It should be noted that when testing at the 5% level of significance with 80% power, the sample size required increases by 27% for a two-sided test as compared to a onesided test. As a result, there is a substantial cost saving if a one-sided test is used. However, agreement is not universal among the regulatory, the academia, and the pharmaceutical industry as to whether a one-sided test or a two-sided test should be used.
Feasibility of seamless adaptive design: The use of adaptive design methods in clinical trials has become very popular in recent years due to their flexibility and efficiency for identifying any signals of safety and/or efficacy (preferably optimal clinical benefit) of a test treatment under investigation. As indicated by Chow and Chang (2006), there are several different types of adaptive designs depending upon the nature of adaptations applied either before, during, or after the conduct of a clinical trial.
Controversial Statistical Issues in Clinical Trials (Chapman & Hall CRC Biostatistics Series) by Shein-Chung Chow