I applaud your efforts, Ravi. Regarding "Whose data is it?", I humbly suggest that referees and editorial boards push (demand?) for rules that require the raw data be made available to the referees and concurrent with publication.

      Spencer


On 1/7/2011 8:43 AM, Ravi Varadhan wrote:
I have just recently written about this issue (i.e. open learning and data
sharing) in a manuscript that is currently under review in a clinical
journal.  I have argued that data hoarding is unethical.  Participants in
research studies give their time, effort, saliva and blood in the altruistic
hope that their sacrifice will benefit humankind.  If they were to realize
that the real (ulterior) motive of the study investigators is only to
advance their careers, they would really think hard about participating in
the studies.  The study participants should only consent to participate if
they can get a signed assurance from the investigators that the
investigators will make their data available for scrutiny and for public use
(under some reasonable conditions that are fair to the study investigators).
As Vickers (Trials 2006) says, "whose data is it anyway?"  I believe that we
can achieve great progress in clinical research if and only if we make a
concerted effort towards open learning. Stakeholders (i.e. patients,
clinicians, policy-makers) should demand that all the data that is
potentially relevant to addressing a critical clinical question should be
made available in an open learning environment.  Unless, we can achieve this
we cannot solve the problems of publication bias and inefficient and
sub-optimal use of data.

Best,
Ravi.
-------------------------------------------------------
Ravi Varadhan, Ph.D.
Assistant Professor,
Division of Geriatric Medicine and Gerontology School of Medicine Johns
Hopkins University

Ph. (410) 502-2619
email: rvarad...@jhmi.edu


-----Original Message-----
From: r-help-boun...@r-project.org [mailto:r-help-boun...@r-project.org] On
Behalf Of Spencer Graves
Sent: Friday, January 07, 2011 8:26 AM
To: Mike Marchywka
Cc: r-help@r-project.org
Subject: Re: [R] Waaaayy off topic...Statistical methods, pub bias,
scientific validity

        I wholeheartedly agree with the trend towards publishing datasets.
One way to do that is as datasets in an R package contributed to CRAN.


        Beyond this, there seems to be an increasing trend towards journals
requiring authors of scientific research to publish their data as well.  The
Public Library of Science (PLOS) has such a policy, but it is not enforced:
Savage and Vickers (2010) were able to get the raw data behind only one of
ten published articles they tried, and that one came only after reminding
the author that s/he had agreed to making the data available as a condition
of publishing in PLOS.  (Four other authors refused to share their data in
spite of their legal and moral commitment to do so as a condition of
publishing in PLOS.)


        There are other venues for publishing data.  For example, much
astronomical data is now routinely web published so anyone interested can
test their pet algorithm on real data
(http://sites.google.com/site/vousergroup/presentations/publishing-astronomi
cal-data).



        Regarding my earlier comment, I just found a Wikipedia article on
"scientific misconduct" that mentioned the tendency to refuse to publish
research that proves your new drug is positively harmful.  This is an
extreme version of both types of bias I previously mentioned:  (1) only
significant results get published.  (2) private funding provides its own
biases.


        Spencer


#########
Savage and Vickers (2010) "Empirical Study Of Data Sharing By Authors
Publishing In PLoS Journals", Scientific Data Sharing, added Apr. 26, 2010
(http://scientificdatasharing.com/medicine/empirical-study-of-data-sharing-b
y-authors-publishing-in-plos-journals-2
<http://scientificdatasharing.com/medicine/empirical-study-of-data-sharing-b
y-authors-publishing-in-plos-journals-2/>).




On 1/7/2011 4:08 AM, Mike Marchywka wrote:





Date: Thu, 6 Jan 2011 23:06:44 -0800
From: peter.langfel...@gmail.com
To: r-help@r-project.org
Subject: Re: [R] Waaaayy off topic...Statistical methods, pub bias,
scientific validity

 From a purely statistical and maybe somewhat naive point of view,
published p-values should be corrected for the multiple testing that
is effectively happening because of the large number of published
studies. My experience is also that people will often try several
statistical methods to get the most significant p-value but neglect
to share that fact with the audience and/or at least attempt to
correct the p-values for the selection bias.
You see this everywhere in one form or another from medical to
financial modelling. My solution here is simply to publish more raw
data in a computer readable form, in this case of course something
easy to get with R, so disinterested or adversarial parties can run their
own "analysis."
I think there was also a push to create a data base for failed drug
trials that may contain data of some value later. The value of R with
easily available data for a large cross section of users could be to
moderate problems like the one cited here.

I almost
slammed a poster here earlier who wanted a simple rule for "when do I
use this test" with something like " when your mom tells you to" since
post hoc you do just about everything to assume you messed up and
missed something but a priori you hope you have designed a good
hypothesis. And at the end of the day, a given p-value is one piece of
evidence in the overall objective of learning about some system, not
appeasing a sponsor. Personally I'm a big fan of post hoc analysis on
biotech data in some cases, especially as more pathway or other theory
is published, but it is easy to become deluded if you have a conclusion
that you know JUST HAS TO BE RIGHT.
Also FWIW, in the few cases I've examined with FDA-sponsor rhetoric,
the data I've been able to get tends to make me side with the FDA and
I still hate the idea of any regulation or access restrictions but it
seems to be the only way to keep sponsors honest to any extent. Your
mileage may vary however, take a look at some rather loud disagreement
with FDA over earlier DNDN panel results, possibly involving threats
against critics. LOL.




That being said, it would seem that biomedical sciences do make
progress, so some of the published results are presumably correct :)

Peter

On Thu, Jan 6, 2011 at 9:13 PM, Spencer Graves
   wrote:
       Part of the phenomenon can be explained by the natural
censorship in what is accepted for publication:  Stronger results
tend to have less difficulty getting published.  Therefore, given
that a result is published, it is evident that the estimated
magnitude of the effect is in average larger than it is in reality,
just by the fact that weaker results are less likely to be
published.  A study of the literature on this subject might yield an
interesting and valuable estimate of the magnitude of this selection
bias.

       A more insidious problem, that may not affect the work of
Jonah Lehrer, is political corruption in the way research is funded,
with less public and more private funding of research

(http://portal.unesco.org/education/en/ev.php-URL_ID=21052&URL_DO=DO_TOPIC&U
RL_SECTION=201.html).
   For example, I've heard claims (which I cannot substantiate right
now) that cell phone companies allegedly lobbied successfully to
block funding for researchers they thought were likely to document
health problems with their products.  Related claims have been made
by scientists in the US Food and Drug Administration that certain
therapies were approved on political grounds in spite of substantive
questions about the validity of the research backing the request for
approval (e.g., www.naturalnews.com/025298_the_FDA_scientists.html).
Some of these accusations of political corruption may be groundless.
However, as private funding replaces tax money for basic science, we
must expect an increase in research results that match the needs of
the funding agency while degrading the quality of published
research.  This produces more research that can not be replicated --
effects that get smaller upon replication.  (My wife and I routinely
avoid certain therapies recommended by physicians, because the
physicians get much of their information on recent drugs from the
pharmaceuticals, who have a vested interest in presenting their
products in the most positive light.)

                                        
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