
One-Third of Clinical Trial Results Never Disclosed, Study Finds - adamlvs
http://www.bloomberg.com/news/articles/2016-02-17/one-third-of-clinical-trial-results-never-disclosed-study-finds
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pc2g4d
It's not just a waste of funders' money; it's not just an ethical problem
because subjects expected to be advancing science; in my view the real problem
with this low disclosure rate is that it skews the publicly available
literature, almost universally in favor of the proposed new treatment. The low
disclosure rate is the flip side of publication bias. It has the tendency of
favoring the interests of corporations selling treatments at the expense of
patients who end up wasting their money on ineffective (or less-effective-
than-expected) new drugs/methods/procedures.

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refurb
This problem goes far beyond clinical trials to science in general. What kind
of journal wants to publish results that are negative?

The only time I've ever seen negative results published is if someone tries to
repeat "known" science, fails to do so, but finds something interesting in the
mean time.

I used to hear these complaints about negative results in chemistry. The
problem is, _most_ scientific experiments (including clinical trials) are
negative. If published, you'd need to increase the number of papers by ~500%
to include all these failed experiments.

~~~
Joof
This is a pretty big problem. I've given it some thought, but haven't cone
across a good answer. Incentivizing this is hard right now.

The best idea I've had is to minimize effort for negative experiments. Like
arxiv, but perhaps a even less formal. Allow it to be easily searchable. It's
still not incentivized, but it's a fuckton easier to put it out there.

I could also see dedicated data analysts publishing negative data of open data
sets.

~~~
pc2g4d
Journals requiring trials to be preregistered could help, if the registration
included a requirement to report at least informally on the outcome of the
trial.

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danieltillett
The solution to the problem is simple. No more grant money until all results
are published. If you run a trial with reporting requirements and fail to do
so then you are banned from getting any further funding. A credible threat to
cut off funding will get the results out ASAP. If you want to make it even
more effective ban the entire university. Peer pressure will work wonders.

To solve the same problem in the private pharma industry just refuse to
approve any new drugs from any company unless all trials are reported within x
time period.

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Gatsky
It can take a while for results to get published - it's often up to the whims
of the journal/reviewers.

Just make them release the raw data. That will definitely encourage people to
publish.

Although these stats look bad for the researchers, the other side of the story
is that publishing anything these days is a pretty painful and not exactly
transparent process.

~~~
danieltillett
Yes this is true - I think you have are supposed to have two years after the
trial ends to publish the results. This study was more than 5 years later so I
don’t think we can blame reviewers or editors for the delay.

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tel
Good related article from Stat News

[http://www.statnews.com/2015/12/13/clinical-trials-
investiga...](http://www.statnews.com/2015/12/13/clinical-trials-
investigation/)

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SilasX
"What does it matter, if those were the trials that didn't find anything
interesting?" \-- grant writer

~~~
Joof
"Fuuuuuuuuu" \-- everyone else

Because now we know not to try it again (and there may be interesting things
we haven't found yet). We can also review the methods and see if it can be
done better.

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jgalt212
In related news:

2/3rds of Hedge Fund returns never disclosed.

~~~
toomuchtodo
Hedge funds are not run with public money.

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refurb
Do you know who fails to update clinicaltrials.gov the most? Researchers using
public money (NIH, publicly funded academic institutes). Pharma companies have
a much better compliance rate.[1]

[1][http://www.statnews.com/2015/12/13/clinical-trials-
investiga...](http://www.statnews.com/2015/12/13/clinical-trials-
investigation/)

~~~
toomuchtodo
Why would I not take issue with that? If you used public money for a study,
you should be required by law to release the data.

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MCRed
If you discover a problem with a product, you either don't release it or you
fix it. You don't need to tell others (and others don't have a right) what
you've discovered.

To think otherwise is to think that my invention that I have locked up in my
head that would benefit society (according to you) is something you have the
right to force me to disclose.

Privacy exists for reasons and is a basic human right.

EG: do those who think you should have to disclose everything you know have
pins on their phones? Think Apple shouldn't be encrypting phone data?

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dsjoerg
In general you have a point, but in this case the research was conducted at
"major U.S. universities and academic hospitals".

The funding rules for academic institutions should be changed to require pre-
registration and disclosure of clinical trials; because that will better
further the academic community's ultimate goal of expanding our communal
knowledge.

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2-18_throw
As you might be aware, all clinical trials begun in the US since late 2007
must register with clinicaltrials.gov before the trial begins. Interestingly,
this includes trials conducted overseas but which use drugs/devices
manufactured in the US. [1]

This requirement includes studies funded privately as well as studies funded
with public funds.

[1] [https://clinicaltrials.gov/ct2/manage-
recs/faq#complyFDAAA](https://clinicaltrials.gov/ct2/manage-
recs/faq#complyFDAAA)

