Democratic Underground Latest Greatest Lobby Journals Search Options Help Login
Google

Most Failed Clinical Trials are Never Published

Printer-friendly format Printer-friendly format
Printer-friendly format Email this thread to a friend
Printer-friendly format Bookmark this thread		 This topic is archived.
Home » Discuss » Topic Forums » Health Donate to DU
 
Hannah Bell Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:11 AM
Original message
Most Failed Clinical Trials are Never Published
Pharmalot.com
By Ed Silverman // September 23rd, 2008 // 8:33 am

A review of 909 clinical trials for 90 meds approved by the FDA between 1998 and 2000 found that more than half of the studies concluding a drug was ineffective were never published in medical journals. The review was published in PLoS Medicine.

http://www.pharmalot.com/2008/09/most-failed-clinical-trials-are-never-published/
Printer Friendly | Permalink |  | Top
Teaser Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:12 AM
Response to Original message
1. The file drawer effect
you can actually test for that with certain statistical assumptions.
Printer Friendly | Permalink |  | Top
 
Fire_Medic_Dave Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:49 AM
Response to Original message
2. Depending upon why they failed it might be a good idea to not publish them.
If there were problems with the methodology publishing those results could seriously damage a scientists career, possibly through the fault of a grad student. Just a thought. Although I'm sure that's not usually the case, my guess is that would be one of their arguments.

David
Printer Friendly | Permalink |  | Top
 
Warpy Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:52 AM
Response to Reply #2
3. Most of them fail at the animal study level
and some even fail at the tissue culture level. Unless some new and different mechanism for failure was discovered in the process, there is simply no reason to publish a detailed paper. The only thing to do is add it to the list of things that looked like they should have worked but didn't.

There's nothing sinister in this, it's just reasonable allocation of resources.

Usually, though, when something gets to human trials after passing all the preliminary work and fails spectacularly, papers are generated.

Remember Thymosin?
Printer Friendly | Permalink |  | Top
 
Hannah Bell Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:56 AM
Response to Reply #3
6. “We found that there was indeed a pattern that favorable studies were more likely to be published
...than unfavorable trials,” Ida Sim, associate professor of internal medicine at UCSF and the lead author of the analysis, tells Bloomberg News. “This is something that is essentially structural in the way clinical trial information is disseminated to the public.”

...The study, by the way, didn’t examine whether trials were submitted and rejected by journal editors or simply weren’t submitted at all, Bloomberg notes. Sim explains that previous research has shown the primary reason for publication bias is that companies or investigators don’t submit them.
Printer Friendly | Permalink |  | Top
 
Hannah Bell Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:53 AM
Response to Reply #2
4. Funny methodological problems are more likely when the results
aren't what the drugmakers wish...
Printer Friendly | Permalink |  | Top
 
Fire_Medic_Dave Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:54 AM
Response to Reply #4
5. That would agree with what I said.
Although I don't believe it's quite as sinister as you might think.

David
Printer Friendly | Permalink |  | Top
 
Hannah Bell Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 12:57 AM
Response to Reply #5
7. not really, dave.
Printer Friendly | Permalink |  | Top
 
Fire_Medic_Dave Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 01:06 AM
Response to Reply #7
8. The Derek Zoolander School for kids who don't read so good.
Printer Friendly | Permalink |  | Top
 
Hannah Bell Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 01:24 AM
Response to Reply #8
9. you never fail me, dave.
Printer Friendly | Permalink |  | Top
 
Fire_Medic_Dave Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 01:12 PM
Response to Reply #9
11. I try my best.
Printer Friendly | Permalink |  | Top
 
trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 10:39 AM
Response to Original message
10. In related news,
most products that fail testing are never sold.

The information we're missing here (which you appear to be assuming) is whether the drugs found to be ineffective were all manufactured and sold anyway. That would be useful to know in order to make any judgments.
Printer Friendly | Permalink |  | Top
 
Hannah Bell Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 01:57 PM
Response to Reply #10
12. The study was on approved drugs,
Over half of all supporting trials for FDA-approved drugs remained unpublished 5 y after approval.

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050191
Printer Friendly | Permalink |  | Top
 
trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 02:10 PM
Response to Reply #12
13. Thank you for posting the link to the real study instead of the editorial.
That helps clarify the issue - from the Conclusions section:

Pivotal trials and trials with statistically significant results and larger sample sizes are more likely to be published.


This would seem to reinforce the point made by Fire_Medic_Dave, that the unpublished studies may be poorly designed. It seems pretty obvious that a study with a larger sample size is going to be more valid than one with a smaller size.
Printer Friendly | Permalink |  | Top
 
Hannah Bell Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 02:20 PM
Response to Reply #13
14. the real study was linked in the editorial. & the researcher was quoted
Edited on Mon Sep-29-08 02:23 PM by Hannah Bell
on the weight of positive v negative results.

The blogger noted in the first line of the editorial that the study dealt with approved drugs, so that tells me you're not reading, just producing rationalizations. When one doesn't work, you move to the next.
Printer Friendly | Permalink |  | Top
 
trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Mon Sep-29-08 02:27 PM
Response to Reply #14
15. Please stop with your personal attacks. n/t
Printer Friendly | Permalink |  | Top
 
DU AdBot (1000+ posts) Click to send private message to this author Click to view this author's profile Click to add this author to your buddy list Click to add this author to your Ignore list Sat May 04th 2024, 11:25 AM
Response to Original message
Advertisements [?]
 Top

Home » Discuss » Topic Forums » Health Donate to DU

Powered by DCForum+ Version 1.1 Copyright 1997-2002 DCScripts.com
Software has been extensively modified by the DU administrators

Important Notices: By participating on this discussion board, visitors agree to abide by the rules outlined on our Rules page. Messages posted on the Democratic Underground Discussion Forums are the opinions of the individuals who post them, and do not necessarily represent the opinions of Democratic Underground, LLC.

Home  |  Discussion Forums  |  Journals |  Store  |  Donate

About DU  |  Contact Us  |  Privacy Policy

Got a message for Democratic Underground? Click here to send us a message.

© 2001 - 2011 Democratic Underground, LLC