
Proposal to require clinical trials data to be shared for publication - adenadel
http://www.statnews.com/pharmalot/2016/01/27/proposal-data-sharing-remarkable-turning-point-says-yales-krumholz/
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epistasis
> Pharmalot: What do you make, though, of the editors at The New England
> Journal of Medicine? In a recent editorial, they expressed reservations and
> set off a ruckus by saying that some researchers worry about ‘research
> parasites.’

>Krumholz: There are lot of people who feel the research they do is the best
research. It comes across as self-serving and absurd. Science is about
replicating and testing your work. We need scientists to test and investigate
and provide new insights. … Remember, people may make errors and the only way
to catch mistakes and make corrections is to see the data.To call people
parasites who are taking advantage of existing data and using that to generate
new knowledge is not parasitism. That’s synergy and building on work of
others. … Anyone who holds that view is not seeing the big picture about how
different people can work in different ways to help society advance.

There's been a lot of anger at NEJM for this editorial, largely because it
used the brazenly derogatory term "research parasites," more than any other
particular complaint. The same discussion happened last decade in the basic
research community, as gene expression microarray studies started publishing
lots of data, and no single initial publication could fully mine it. Now that
the clinical science community is encountering more of this, and information
dense technologies are being used to gather data during clinical trials, the
same discussion is getting rehashed.

Meanwhile, those whose primary research thrust is analysis of data rather than
generation often have more offers to collaborate than they could ever meet.
They may not get the Science or Nature papers though, as those are typically
reserved for data producers.

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yummyfajitas
The derogatory term is far from the only problem with the NEJM editorial. The
problem is that the article was acting as if publications and socially
approved results are primarily a reward for putting in effort, as opposed to
part of a search for truth.

The article criticized "rude" behavior like using someone's own data to refute
their conclusion. That's the biggest bit of cluelessness in the editorial.

~~~
ranko
Sadly, most researchers are primarily judged on publication record, with the
not-too-subtle subtext that "low" rates of publication are due to lack of
either effort or talent. In such rating exercises, truth is never a factor.

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tokenadult
I'm always glad to see submissions to Hacker News from the new Stat news
service. This submission has a lead paragraph before the interview transcript
that sets a lot of context: "In an extraordinary move, the International
Committee of Medical Journal Editors last week issued a proposal to require
researchers to share their clinical trial data as a condition for publication.
And the researchers would also have to submit plans for how their data can be
shared. The journal editors, who represent such periodicals as The New England
Journal of Medicine and the Annals of Internal Medicine, believe data sharing
'will help to fulfill our moral obligation to study participants, and we
believe it will benefit patients, investigators, sponsors, and society.'"

The key words there are "condition for publication." If researchers can no
longer publish in the major journals without an ironclad guarantee that they
will share their data, the incentive to share data well improves a lot.
Interestingly, the Retraction Watch group-edited blog about scientific
research has a guest post today "Sharing data is a good thing. But we need to
consider the costs"[1] by Liz Wager referring to the same proposal by medical
journals, but suggesting that some other rules would be even more helpful for
improving research.

"I want to re-emphasize that I am not against data sharing. If I had a magic
wand (aka unlimited funding for research and its dissemination) I would
undoubtedly wave it over all research and create a system in which raw data
were permanently linked to all types of report and all the report formats were
linked (so that, for example, somebody reading a press release could easily
check the journal article, and, if they wished, also the protocol, full study
findings and raw data). But if the fairy gave me two wishes instead of a wand,
I would wish for prospective trial registration and access to full trial
reports for all trials before wishing for raw data."

[1] [http://retractionwatch.com/2016/01/28/sharing-data-is-a-
good...](http://retractionwatch.com/2016/01/28/sharing-data-is-a-good-thing-
but-we-need-to-consider-the-costs/#more-36359)

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vitorbaptistaa
If you got curious about this, check Ben Goldacre's website
([http://www.badscience.net/](http://www.badscience.net/)) and the OpenTrials
project ([http://opentrials.net/](http://opentrials.net/)). He wrote a couple
very interesting books about this issue.

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godzillabrennus
I'm helping [http://www.myire.com](http://www.myire.com) which is about to
publicly launch this quarter and is working on this exact problem. It's
everything from ideation to publication allowing for collaboration. Truly
reproducible research.

If you want to chat about it email me hn at strapr dot com and let's talk.

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tuhins
This is pretty awesome. I think what's as important as actually providing the
data + results is details of the steps taken to produce the analysis. Clinical
trials data analysis is often performed by underqualified research assistants
and then sent to a biostatistician for a rubber stamp. Having a mechanism to
review analysis would not only save time in getting potential treatments to
patients, but also reduce the effort required to analyze new datasets.

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lutusp
Quote:

"In an extraordinary move, the International Committee of Medical Journal
Editors last week issued a proposal to require researchers to share their
clinical trial data as a condition for publication."

If this happens, it would turn a very important philosophical and practical
corner in the sciences. It might even prevent things like this:

[http://www.nature.com/news/over-half-of-psychology-
studies-f...](http://www.nature.com/news/over-half-of-psychology-studies-fail-
reproducibility-test-1.18248)

Noteworthy about the above result is that many studies that were to have been
included in the study, couldn't be, because the original data couldn't be
located.

~~~
tejtm
The International Society for Computational Biology has responded here:

[http://news.iscb.org/2016/01/iscb-responds-to-new-england-
jo...](http://news.iscb.org/2016/01/iscb-responds-to-new-england-journal-
of.html?m=1)

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return0
I won't wold my breath for this. Despite a decade of talking about "open
science" there is very very little progress.

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Joof
Finally

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Madmallard
Too bad corrupt pharmaceutical companies and desperate starving researchers
just alter the data.

