post p < .05 era

Hello: On March 7, 2016, the American Statistical Association announced a statement regarding p-value (click http://amstat.tandfonline.com/doi/abs/10.1080/00031305.2016.1154108"). I welcome this statement, especially because of some clinical teams that design PoC studies to focus mainly on generating a "good p-value" for Go/No-go decisions rather than "learning". In my opinion, a p-value that follows a hypothesis test could be useful but, with the same budget, a PoC study should be informative to design the next study for confirming efficacy (and/or safety) with a good p-value for a clearer regulatory decision. This is a seminal paper that emphasizes the importance of clinical pharmacology approach over empirical p-value driven drug development approach: Learning versus confirming in clinical drug development. Sheiner http://www.ncbi.nlm.nih.gov/pubmed/?term=Sheiner%20LB%5BAuthor%5D&cauthor=true&cauthor_uid=9084453. Clin Pharmacol http://www.ncbi.nlm.nih.gov/pubmed/?term=peck+shiener+rubin 1997 Mar;61(3):275-91. A recent development in considering "totality" of data in designing and/or approving a pediatric drug with less emphasis on p-value (my interpretation) can be found in: (Draft) Reflection paper on extrapolation of efficacy and safety in paediatric medicine development (April 1, 2016) Click http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/04/WC500204187.pdf I look forward to living in the post p< .05 era in drug development! Kind regards, Holly Kimko Clinical Pharmacology & Pharmacometrics Janssen Research & Development, LLC *~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~* Monday, March 07, 2016 11:15 AM Today, the American Statistical Association Board of Directors issued a statement on p-values and statistical significance. We intend the statement, developed over many months in consultation with a large panel of experts, to draw renewed and vigorous attention to changing research practices that have contributed to a reproducibility crisis in science. "Widespread use of 'statistical significance' (generally interpreted as 'p < 0.05') as a license for making a claim of a scientific finding (or implied truth) leads to considerable distortion of the scientific process," says the ASA statement (in part). By putting the authority of the world's largest community of statisticians behind such a statement, we seek to begin a broad-based discussion of how to more effectively and appropriately use statistical methods as part of the scientific reasoning process. In short, we envision a new era, in which the broad scientific community recognizes what statisticians have been advocating for many years. In this "post p < .05 era," the full power of statistical argumentation in all its nuance will be brought to bear to advance science, rather than making decisions simply by reducing complex models and methods to a single number and its relationship to an arbitrary threshold. This new era would be marked by radical change to how editorial decisions are made regarding what is publishable, removing the temptation to inappropriately hunt for statistical significance as a justification for publication. In such an era, every aspect of the investigative process would have its appropriate weight in the ultimate decision about the value of a research contribution. Is such an era beyond reach? We think not, but we need your help in making sure this opportunity is not lost. The http://amstat.tandfonline.com/doi/abs/10.1080/00031305.2016.1154108 is available freely online to all at The American Statistician Latest Articles http://amstat.tandfonline.com/action/showAxaArticles?journalCode=utas20. You'll find an introduction that describes the reasons for developing the statement and the process by which it was developed. You'll also find a rich set of discussion papers commenting on various aspects of the statement and related matters. This is the first time the ASA has spoken so publicly about a fundamental part of statistical theory and practice. We urge you to share this statement with appropriate colleagues and spread the word via social media. We also urge you to share your comments about the statement with the ASA Community via ASA http://community.amstat.org/home. Of course, you are more than welcome to email your comments directly to us at [email protected]<mailto:[email protected]>. On behalf of the ASA Board of Directors, thank you! Sincerely, Jessica Utts President American Statistical Association Ron Wasserstein Executive Director American Statistical Association