Question #1: P-Hacking

Hello everyone, long time listener and first time writer. I drive a lot for work and I love when you cram knowledge in my ears to shape my thinking. On the 10/8 SGU podcast you mentioned the concept of p hacking in the context of power poses. I don't know if I understand the p-hacking concept well. My question centers around research connected to my work. I'm in the process of launching one of the Injectable PCSK9 inhibitors in the cardio-metabolic world. Amgen has one of the products, and Regeneron/Sanofi-Aventis have the other one. We both got FDA marketing approval on the basis of our ability to dramatically lower a surrogate biomarker – LDL cholesterol. The FDA highly encouraged both manufacturer groups to complete outcomes trials to show the true, if any, impact on real world mortality in heart attacks and strokes, for example. Both organizations have initiated large prospective outcomes trials with about a total of forty five thousand patients between them. For example, on Regeneron side, it's a 5 year outcomes trial for 19,000 patients. However, there has been talk that if there is a clear benefit signal early in the trial, that the FDA may be OK with that and allow that outcomes data to be published and change the product label. We may follow the patients after that point, but the FDA and the manufacturers will get what they feel they needed from the trial data. Anyway, if the FDA calls the trial a success and allows us to proclaim we have a clear benefit in MACE, earlier than the actual end of the trial – does that constitute p-hacking? Thanks Heath Bonner Arlington, TX