Clinical Trials 101: Lecture 5

Okay, you ' ve made it through the preliminary rounds and now you ' ve gotten funding for your Phase III trial. In the old days, you could just go ahead and do it and if your sponsoring drug company didn ' t like the results, they would just bury them and not publish. Or, you could do what are called post hoc analyses, trolling through your data to find some endpoint that seemed to come out positive for some sub-group within your sample, and then pretend that ' s what you were looking for all along. Without getting too deep into the philosophical weeds, if you do that, your p values are bogus and the effect probably isn ' t real -- but it was very common to do it anyway.Nowadays, if you have federal funding, or if you want the FDA to consider your trial in the drug approval process, you need to register your trial in advance. That means you need to state very specifically:1. What are the eligibility criteria for the study? That means both inclusion criteria -- you need to have a diagnosis of creeping crud, confirmed by some specified means, probably within a particular (likely early) stage of the disease; and exclusion criteria -- for example, you can ' t be pregnant, you can ' t have certain other comorbidities, you have to be over 18 and under 65, you have to speak English.2. How will people be assigned to the intervention group or groups -- i.e. people might get different doses or courses of treatment -- and the control group or groups -- i.e. some people might get only pl...
Source: Stayin' Alive - Category: American Health Source Type: blogs