Roger L. Berger
School Director & Professor
School of Mathematical & Natural Science
Arizona State University
Comment on S. Senn’s post: “Blood Simple? The complicated and controversial world of bioequivalence”(*)
First, I do agree with Senn’s statement that “the FDA requires conventional placebo-controlled trials of a new treatment to be tested at the 5% level two-sided but since they would never accept a treatment that was worse than placebo the regulator’s risk is 2.5% not 5%.” The FDA procedure essentially defines a one-sided test with Type I error probability (size) of .025. Why it is not just called this, I do not know. And if the regulators believe .025 is the appropriate Type I error probability, then perhaps it should be used in other situations, e.g., bioequivalence testing, as well.
Senn refers to a paper by Hsu and me (Berger and Hsu (1996)), and then attempts to characterize what we said. Unfortunately, I believe he has mischaracterized. Continue reading
Head, Methodology and Statistics Group
Competence Center for Methodology and Statistics (CCMS)
Responder despondency: myths of personalized medicine
The road to drug development destruction is paved with good intentions. The 2013 FDA report, Paving the Way for Personalized Medicine has an encouraging and enthusiastic foreword from Commissioner Hamburg and plenty of extremely interesting examples stretching back decades. Given what the report shows can be achieved on occasion, given the enthusiasm of the FDA and its commissioner, given the amazing progress in genetics emerging from the labs, a golden future of personalized medicine surely awaits us. It would be churlish to spoil the party by sounding a note of caution but I have never shirked being churlish and that is exactly what I am going to do. Continue reading
Since the comments to my previous post are getting too long, I’m reblogging it here to make more room. I say that the issue raised by J. Berger and Sellke (1987) and Casella and R. Berger (1987) concerns evaluating the evidence in relation to a given hypothesis (using error probabilities). Given the information that this hypothesis H* was randomly selected from an urn with 99% true hypothesis, we wouldn’t say this gives a great deal of evidence for the truth of H*, nor suppose that H* had thereby been well-tested. (H* might concern the existence of a standard model-like Higgs.) I think the issues about “science-wise error rates” and long-run performance in dichotomous, diagnostic screening should be taken up separately, but commentators can continue on this, if they wish (perhaps see this related post). Continue reading
0. July 20, 2014: Some of the comments to this post reveal that using the word “fallacy” in my original title might have encouraged running together the current issue with the fallacy of transposing the conditional. Please see a newly added Section 7.
1. What you should ask…
Discussions of P-values in the Higgs discovery invariably recapitulate many of the familiar criticisms of P-values (some “howlers”, some not). When you hear the familiar refrain, “We all know that P-values overstate the evidence against the null hypothesis”, denying the P-value aptly measures evidence, what you should ask is:
“What do you mean by overstating the evidence against a hypothesis?”
I’m reblogging a few of the Higgs posts, with some updated remarks, on this two-year anniversary of the discovery. (The first was in my last post.) The following, was originally “Higgs Analysis and Statistical Flukes: part 2″ (from March, 2013).
Some people say to me: “This kind of reasoning is fine for a ‘sexy science’ like high energy physics (HEP)”–as if their statistical inferences are radically different. But I maintain that this is the mode by which data are used in “uncertain” reasoning across the entire landscape of science and day-to-day learning (at least, when we’re trying to find things out) Even with high level theories, the particular problems of learning from data are tackled piecemeal, in local inferences that afford error control. Granted, this statistical philosophy differs importantly from those that view the task as assigning comparative (or absolute) degrees-of-support/belief/plausibility to propositions, models, or theories. Continue reading
July 4, 2014 was the two year anniversary of the Higgs boson discovery. As the world was celebrating the “5 sigma!” announcement, and we were reading about the statistical aspects of this major accomplishment, I was aghast to be emailed a letter, purportedly instigated by Bayesian Dennis Lindley, through Tony O’Hagan (to the ISBA). Lindley, according to this letter, wanted to know:
“Are the particle physics community completely wedded to frequentist analysis? If so, has anyone tried to explain what bad science that is?”
Fairly sure it was a joke, I posted it on my “Rejected Posts” blog for a bit until it checked out . (See O’Hagan’s “Digest and Discussion”) Continue reading