On gaming: it's very interesting that, even within all of the byzantine rules and regulations and guidances how much gray area and leeway there can be. From a d

On gaming: it's very interesting that, even within all of the byzantine rules and regulations and guidances how much gray area and leeway there can be. From a drug/device company perspective, which people in the FDA assigned as reviewers / contact points for you and how well you are able to articulate & convince them of your goals can play a huge role in whether you have to do X type of trial or adhere to Y rules. This is especially true at the boundaries (new types of testing, devices, technologies) that don't quite exactly fit the more well-trod paths. Not saying this in a judgmental way -- it's just the nature of dealing with extremely complex problems while also making sure people aren't harmed unnecessarily and that at the end when you say drug/device/tech A improves condition B we actually are sure it is true. And then there's the more malicious "gaming", fraud! Clinical research is obviously heavily incentivized toward positive trial outcomes, but for each site the act of just enrolling patients is incentivized, so you need to be damn sure the patient data (and the patients themselves!) in your study are real. And being sure is not easy or cheap. For fun, here's the FDA's list of people who have been blacklisted from performing clinical research: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/fda-debarment-list-drug-product-applications https://www.fda.gov/inspections-compliance-enforcement-and-c... Their associated "Volume Page" lists (in excruciating bureaucratese) their "crimes", which may be unrelated illegal narcotics peddling (oops) or falsifying patient data.