NIH finally announced its plan regarding the publication of clinical trial results and, as expected, the new policy will be to request that researchers post their trial results 12 months after completion of the trial. This policy angered many public access and taxpayer watchdog groups, who argued that 6 months was more appropriate.
I can see the point of the watchdog groups - that NIH seems to pay a lot of attention to what industry associations say, and much less to what the citizens say. With the NIH's mission as the "steward of medical and behavioral research for the Nation," one would think that its primary interest would be for the people, not the companies (as "Nation" is often translated as meaning).
The publishers' argument that having the trial results made public several months before they might be published in one of the journals, which would, therefore, cut into the publishers' revenue doesn't sound like it really could bear up against scrutiny. The main readers of those journals are hospitals, companies, academic institutions and research centers that can afford to pay the subscription fees of hundreds or thousands of dollars a year, not the averge Joe trying to find out a treatment for his kid with leukemia. The journal subscribers get those journals because the journals also usually have other stories, articles and criticisms of the trials and related issues that wouldn't be included in the national database of trial results. So they're not likely to stop getting the journals only because raw data for trials is on an open access website.
But, other than the general argument that NIH seemed to be taking the path of least resistance with the publisher industry, I haven't heard any real strong arguments about the harm that will be done by waiting 6 more months for result publication on the national database. I'm not saying harm couldn't occur, I haven't seen anything specifically articulated that demonstrates how the delay will lead to either economic or physical harms.
The letter from the Scholarly Publishing and Academic Resources Coalition (SPARC) to Dr. Zerhouni (Director of NIH) generally talks about why the publisher's boohooing about losing money from the open access publication is just malarkey. It is missing any real, concrete statement about how public access is damaged because we'll have to wait 12 months instead of 6 to get the raw data on the website. Just to be a Monday morning quarterback, it's not difficult to see why NIH decided on a "compromise" position by softpedaling the publication deadline to 12 months after trial completion.
To me, more than the time delay, it's more disappointing that scientists are just "requested" to do this. There really is no requirement or any real penalty for not publishing the results. So the NIH could have said that scientists should publish the results 6 months after completion, and it wouldn't really matter. Scientists can still say "eh, nah ... not going to publish the results there."
Until there are more teeth in the policy, or sufficient public approbrium is raised against scientists who don't publish, the whole debate about 6 versus 12 months just doesn't get me really excited.
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