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Should unpublished clinical trial results be open access?

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I know how this appears to be an oxymoron.   Can research not published yet be considered for open access, a term associated with a form of publishing?  Read on…..

It’s really a taxpayer access issue.  Imagine you paid for something and  were still waiting more than 30 months to receive it? 50 months?   This was the problem identified earlier this year in a British Medical Journal(BMJ) article, Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis, which shown a bright light on delays in publication of research results, both publicly and privately sponsored.  Here’s a sample of the article’s final discussion:

British Medical Journal

Discussion

In a sample of NIH funded clinical trials registered in ClinicalTrials.gov, we found that fewer than half of trials were published in a peer reviewed biomedical journal indexed in Medline within 30 months of trial completion, although there were more recent improvements in timely publication. Furthermore, after a median of 51 months after study completion, we found that about a third of NIH funded trials remained unpublished. Twenty years ago, a single study focused on trials funded by NIH in 1979 found that 93% of completed trials were published within 10 years, using a broader definition of publication that included research abstracts, book chapters, and other non-Medline indexed sources. In contrast, a larger body of work focused on industry sponsored studies suggested that between 25% and 50% of clinical trials remain unpublished even several years after completion. Our results suggest that patterns of publication are similar for publicly funded and for industry funded clinical trial research and that substantial amounts of publicly funded research data are not published and available to inform future research and practice. Full Article Here

I wasn’t sure how I was going to eventually blog about this, but watching 60 Minutes tonight while eating leftover pizza (my own buffalo chicken pizza), my interest was revived. If you missed it (Treating Depression: Is there a placebo effect?) about the conflicting opinions about drugs or placebos  (or not) for treating depression, take a few minutes to watch it now. Pay particular attention to when the get to the point of Dr. Irving Kirsch having to use the Freedom of Information Act (FOAI) to request the unpublished study data from the Food and Drug Administration (FDA) :

So at least one  point of our wonder with the obstacles Dr. Kirsch is facing is that the FDA will make a decision to approve a drug when at least two clinical trial studies show a positive effect, even if there were 10 additional clinical trial studies that failed to prove an effect.   Now we saw Dr. Kirsch on camera thumbing through the FOAI-requested  clinical trial data in a bound notebook format.

I know a  bit about U.S. copyright law(pdf): “copyright protection subsists from the time the work is created in fixed form”.   I think what the millions of us watching the show were seeing on camera was a fixed format.  Of course,  an entity of the US Government cannot claim copyright over something it creates,  yet the government is not precluded from receiving and holding copyrights transferred to it by assignment, bequest, or otherwise.

What if as a condition of a NIH grant, any unpublished research data supplied to the FDA could in fact be formatted and released publicly (after a minimum embargo period to allow researchers to publish with their use of the data first, an amount much less than 30 months)  in some sort of federal repository, eliminating the time and expense of FOIA requests?   I am considering NIH-funded studies for this repository “publication.”   Data the FDA receives from privately funded studies would still be available through the more time-consuming FOAI request route.

There are issues raised by the BMJ  article and the 60 Minutes show.  A federal clinical trial data repository, with unpublished study results open and accessible to research interpretation and analysis, might be a useful solution to access which support public health and public interest in both these cases.

If you know of history around this notion, please comment and provide links.

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Sun, February 19 2012 » Uncategorized

2 Responses

  1. Bev A February 20 2012 @ 07:49

    See http://www.controlled-trials.com/ from BioMed Central and our new project on threaded publications http://bit.ly/yvJuFT for what we are trying to achieve in this area.

  2. cjgberg February 20 2012 @ 23:13

    Thank you! I will pass this on to the systematic review educators at my library.

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