Stephen Senn writes:
For many years now I [Senn] have been making the point that obtaining a license to market a drug should carry with it the obligation to share the results with interested parties. . . .
Amongst those misunderstanding the issues, are many who work in the pharmaceutical industry. A common assumption is that any company that releases data will help competitors who will, of course, mine their publicly released information for valuable insights. The point is, however, that releasing companies will also gain such information from their competitors and this is not a zero-sum game. On average, the industry should be better off. The problem is that it is to nobody’s advantage to be the first to reveal and it is in this context that strong regulatory action is desirable.
Hey—as a political scientist, I can definitely relate to that sort of prisoner’s dilemma argument.
However, some of those associated with the campaign have also misunderstood an important point. Publication in the medical press must become irrelevant. Self-publication is necessary.
The first reason is that submission to a journal is not enough to guarantee publication, since the editors may reject the paper. The second reason is that journals may have a bias against negative studies. Although a great deal of research on this topic claims that this is not true, this research is inadequate for reasons I have explained in detail elsewhere. In particular researchers have naively (implicitly) assumed that authors make their decision to submit to a given journal based on quality of the research but not on anticipated probability of its acceptance. If the latter is the case we would not necessarily see different acceptance rates of papers submitted but higher quality of the negative papers.
The third reason is that the review process, by requesting changes in statistical analysis, can harm the quality of a trial which (certainly, if it is a phase III pharmaceutical trial) will have had a detailed proposal for the statistical analysis registered prior to un-blinding the data. Whether or not, others subsequently decide that alternative analyses are superior, it is important as a matter of historical record that the results of the pre-specified analysis are available. . . .
Thus, the whole business of journal publishing simply adds confusion to the process of making trial results available. . . .
My solution is rather different. I think that we should move to a system where in addition to Q for quality, E for efficacy and S for safety aspects of a drug and, increasingly, V for value for money, we should have a P for publication requirement. By publication I do not mean publication in journals, I mean self-publication on the web or in some publicly searchable registry such as ClincalTrials.gov [emphasis added]. . . . Forget the journals. Let’s look elsewhere.
This represents an interesting convergence, from the applied side, with Larry Wasserman’s suggestion that researchers in statistical theory and methods abandon journals and just post articles on Arxiv. From both directions there is a sense that journal publication is causing more harm than good.