clinical trials visited again… »
« clinicaltrials.gov revisited…
drugs@FDA visited…

Posted on Tuesday 20 September 2016

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 unlike the bridal registries filled out by prospective brides as the big day approaches…
I didn’t mean to trivialize it – just to describe it as a structured database. It really is part of a complex governmental agency – the National Institute of Health. On the other hand, the web site, drugs@FDA isn’t really a structured database. It’s just an Internet menu system in front of what data they have made available [which is like swiss cheese – some really good stuff with lots of holes]. You start with a screen that looks like this:
So you wind your way through several screens to find the drug you’re looking for, ending up on a screen like this:
 
It’s that highlighted link that says "Approval History, Letters, Reviews, and Related Documents" that’s what you came for. It leads to a screen with a table like this:
 
It’s the Reviews you’ve come to find. The rest of it is stodgy labeling revisions and moderately unintelligible letters in beaurocratese. So pick one [here‘s the link to Abilify‘s initial Review]. At this point, it seems like every single drug is different. Sometimes there’s nothing there [because they haven’t put anything there], particularly with newer drugs. And sometimes they’re like this Abilify selection – pages and pages of pdfs.

It may seem like in describing the hit-or-miss quality of this site and its sometimes chaotic organization, I’m complaining. Quite the contrary. I’m mentioning it for several reasons. First, my impression is that it’s not often visited, being the haunt of people who do systematic reviews rather than mere mortals. But mainly I want to say that after five or six years of repeatedly looking up things here, I’m impressed. These reviews are extensive. They’re all different in that the reviewers "follow their noses" going through the data. Sometimes they reanalyze the raw data, slicing and dicing it in different ways from the way it’s submitted. Sometimes they explore different analytic methods. But I’ve never found one where the didn’t follow the a priori protocol or took the sponsor’s version and computation for granted. Their standard is low [two positive studies], but they go at it competently. The statistical reviews are often illuminating. I’ve disagreed with their conclusions at times, but never their methodology or thoroughness. These reports are reviewed by committees who say yeah or nay. Actually, so do the reviewers. And I think the final decision rests with the director of the FDA.

They’re obviously in no hurry to post their documents or to be comprehensive [did I mention swiss cheese], but that’s not what they’re for. And I’ve been glad for what I could get. I’m talking about this for a specific reason. The intended public interface for clinical trials is clinicaltrials.gov, an NIH database created to describe the trial design, its progress, and its results. But it has been purposefully underpopulated and essentially rendered impotent. The real information is inside the FDA with its ability to see all the information [see Evidence of Clinical Effectiveness and Data Requirements For an NDA], but it’s latecoming to their site and spotty for the likes of those of us who try to investigate these drugs and vet the published studies.

Two windows into the Clinical Trials results just across town from each other, but in some ways, they might as well be on the opposite poles of the planet:

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