I’ve heard from several people that they’re not sure exactly what we’re asking Congress to do. Our narrative is long because it coveres many bases. Here’s the short version. We want Congress to mandate that the FDA talk to us directly through clinicaltrials.gov about the clinical trials of FDA regulated drugs. The drug and device […]
[see also clinical trials – an act of congress!…] In the course of a Clinical Trial on an FDA regulated drug, the Sponsor submits information to three distinct entities – each with a different purpose: NIH [clinicaltrials.gov]: …clinicaltrials.gov is intended to be the public interface for the clinical trial, The first submission [registration] describes the […]
My posts last week were meant to be a prequel to this one. In clinicaltrials.gov revisited… and drugs@FDA visited…, I tried to present a simple outline of the two agency online windows into the world of clinical trials for anyone who hasn’t already explored them. And in clinical trials visited again… and clinical trials – […]
Well our second Paxil Study 329 paper was published at the end of last week. I waited to mention it here until David Healy had a post about it – out today [see Study 329 Continuation Phase]. We originally submitted it to the Journal of the American Academy of Child and Adolescent Psychiatry who turned […]
At the risk of overworking my Rip Van Winkle analogy, before I went to sleep in the early 1980s, I recall that conflict of interest standards in medicine and science were similar to those for our judicial counterparts – even the possibility of a conflict of interest was grounds for recusal. Had someone announced in […]
When I left the faculty in the early 1980s in the wake of the medicalization of our department after the DSM-III revolution, I didn’t think of it as leaving psychiatry [I sort of thought of it as psychiatry leaving me]. But circumstances were such that I got busy with my practice and teaching, drifting further […]
My preacher friend Andy had a book, The Concordance, that showed the four gospels with their different accounts of the same event aligned to be side by side. I liked the idea, and used it in my own teaching on a very different topic. But in this case, I’m co-opting the term to say that […]
By all rights, the usual randomized clinical trial [RCT] of a medication ought to be relatively straightforward: Decide on the target population, the intervention arms of the study, and what outcome difference you would accept as clinically meaningful. Do the power computations to determine the study’s size. Preregister the study, declaring the Primary and Secondary […]
Whereas clinicaltrials.gov was designed to be a public online interface with structured data fields, drugs@FDA is a different species altogether. In clinicaltrials.gov revisited…, I joked… While it’s discussed almost like it’s some complex governmental agency, clinicaltrials.gov is just a very large, online, searchable database of clinical trials using human subjects. It’s only a registry, not […]
With all the reports of the NIH/FDA reforms coming out yesterday, I thought I’d dabble in the details of the various elements being discussed. Usually, one would start with an abstract discussion of how such a thing as clinicaltrials.gov came to be and what it was intended to accomplish, but this time I think it […]