6 ms·

Tool 'names and shames' hidden drug trials

87 points by asplake 9y ago

nmca 9y ago
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 9y ago
  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 9y ago
    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.
- ZeroGravitas 9y ago
  There's also a book called Bad Medicine: Doctors Doing Harm Since Hippocrates from Oxford University Press. https://global.oup.com/academic/product/bad-medicine-9780199212798 https://global.oup.com/academic/product/bad-medicine-9780199... It's not by the same author, but adds a nice historical perspective. On a long scale, medicine is mostly about harming your patient with treatements that are worse than nothing.
ChrisSD 9y ago
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 9y ago
  The codes have been in effect for less than a month.
  - ChrisSD 9y ago
    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?
  - rkangel 9y ago
    Ah. That bit of missing context makes a big difference.
pella 9y ago
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/issues https://github.com/ebmdatalab/clinicaltrials-act-tracker/iss...
lolc 9y ago
Nice! Didn't know that law existed in the first place. Good to see it's being monitored right from inception.
refurb 9y ago
My understanding is that pharma companies have been much more compliant with reporting than public institutions.
- wireblitz 9y ago
  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.
hateful 9y ago
I can't be the only one who thought this was about the band Tool.
- ndesaulniers 9y ago
  New album soon...been holding my breath for what feels like 10,000 days.
- david-cako 9y ago
  BLAME HOFMANN
jonlucc 9y ago
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 9y ago
  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.
scottmcdot 9y ago
I initially read this as the band Tool.

87 points by asplake 9y ago

nmca 9y ago

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 9y ago
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 9y ago
  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.
ZeroGravitas 9y ago
There's also a book called Bad Medicine: Doctors Doing Harm Since Hippocrates from Oxford University Press. https://global.oup.com/academic/product/bad-medicine-9780199212798 https://global.oup.com/academic/product/bad-medicine-9780199... It's not by the same author, but adds a nice historical perspective. On a long scale, medicine is mostly about harming your patient with treatements that are worse than nothing.

ChrisSD 9y ago

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 9y ago
The codes have been in effect for less than a month.
- ChrisSD 9y ago
  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?
- rkangel 9y ago
  Ah. That bit of missing context makes a big difference.

pella 9y ago

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/issues https://github.com/ebmdatalab/clinicaltrials-act-tracker/iss...

lolc 9y ago

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

refurb 9y ago

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

wireblitz 9y ago
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.

hateful 9y ago

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

ndesaulniers 9y ago
New album soon...been holding my breath for what feels like 10,000 days.
david-cako 9y ago
BLAME HOFMANN

jonlucc 9y ago

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 9y ago
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.

scottmcdot 9y ago

I initially read this as the band Tool.