
Tool 'names and shames' hidden drug trials - asplake
http://www.bbc.co.uk/news/technology-43119035
======
nmca
I hope that this is widely used, and that Private Eye picks up on it as a
source of information. Also if any commenters haven't read "Bad Science", and
the follow-up "Bad Pharma" by Ben Goldachre (who inspired the tool) they are
well worth a read.

~~~
AndrewOMartin
Bad Science is a very insightful and witty read with as many shocking parts as
there are hilarious parts.

It's a while since I tried to read it, but Bad Pharma seemed to be much more
focused on the fundamental problem and its effect, which I found to be a very
hard read, I never finished it. No fault of Goldacre's writing, it's just a
horribly horrible and massively massive problem.

~~~
alex_hitchins
Yep - Also found it a hard to read. I recommend the Audio Book read by Ben,
much easier to consume the information having it read out. Plus, Ben has a
lovely voice which helps.

------
ChrisSD
From the FDA:

> It is often not possible to determine which parties may be non-compliant
> based solely on the information in the record that is publicly posted on
> clinicaltrials.gov

Considering that "nobody has ever been penalised for breaching those codes",
this sounds like a handwave. What's the point of the website if it doesn't
accurately report missed deadlines? Or if missing deadlines doesn't breach the
rules then in what sense are they deadlines?

~~~
ameister14
The codes have been in effect for less than a month.

~~~
ChrisSD
Right but now that the codes are in effect, what about the website makes it
"often not possible" to tell if anyone is non-compliant?

------
jonlucc
I'm a little confused here. All trials have to be reported within 12 months of
completion, and the law goes into full effect in February. So the tool gives
the trials which have been overdue for some part of February?

The "US govt could have imposed fines" part seems to be way off too (unless
maybe it's in thousands?). It says they can levy fines of $10k/day. Just
clicking on one company, Bassett Healthcare, shows there is 1 trial overdue by
32 days. Only 22 days have elapsed in February (when it sounds like this
portion of the law went into effect), so shouldn't that company be able to be
fined at least 22*$10k=$220k? It has the total for all companies at $290k on
the home page.

Maybe I'm misunderstanding something, but the tool doesn't have a lot of
description that I could find.

~~~
wireblitz
The fines would be administered for each day the trial is late. Technically,
sponsors have 1 year to post results after the primary completion date stated
on ct.gov. This is supposed to be the anticipated date that the last primary
outcome measure is collected. Therefore, if a sponsor estimated to collect
that final measure on 12/1/2018, they would need to have results registered on
ct.gov on 12/1/2019\. If they were missing results on 12/2/2019 (and there are
no certified delayed results) they'd be fined 10K for that day. Also worth
noting that the sponsor would receive a notice that their out of compliance
and have 30 days to rectify before a fine is issued.

------
pella
now: "Percent reported: 89.7%"

website: [http://fdaaa.trialstracker.net/](http://fdaaa.trialstracker.net/)

github: [https://github.com/ebmdatalab/clinicaltrials-act-
tracker/](https://github.com/ebmdatalab/clinicaltrials-act-tracker/)

github issues: [https://github.com/ebmdatalab/clinicaltrials-act-
tracker/iss...](https://github.com/ebmdatalab/clinicaltrials-act-
tracker/issues)

------
lolc
Nice! Didn't know that law existed in the first place. Good to see it's being
monitored right from inception.

------
refurb
My understanding is that pharma companies have been much more compliant with
reporting than public institutions.

~~~
wireblitz
Yeah, most pharma companies have clinical trial disclosure teams whose sole
responsibility is disclosure to various registries. Most public universities
and hospitals with large research facilities usually register studies, but the
data is crap and isn't maintained with the same rigor as a pharma company.
That being said pharma companies are more likely to omit confidential
information regarding thier products.

------
scottmcdot
I initially read this as the band Tool.

------
hateful
I can't be the only one who thought this was about the band Tool.

~~~
ndesaulniers
New album soon...been holding my breath for what feels like 10,000 days.

