According to Pharmafile, almost 30% of clinical trials for new drugs go unpublished up to five years after completion. Of those unpublished studies, almost 80% release no data at all for consideration by the public.
The Pharmafile article takes issue with this on the grounds that people who risked their health to participate in a clinical trial in order to benefit society are being shortchanged, since the results of those risks are effectively being withheld from the public. (Although I largely agree with this, I also don’t think all that many people participate in clinical trials solely out of the good of their hearts; the idea of “experimental” treatments probably carries a good deal of hope for some patients as well). The article breaks all of this down by the numbers but mostly discusses the issue from that angle.
I believe, however, that the patients who are involved in these trials are not the only ones shortchanged by such a result (or lack thereof). A study conducted by researchers from Yale School of Medicine found that fewer than half of the NIH-funded clinical trials in their sample were published by 30 months after trial completion, and one-third were still unpublished by a full 51 months after the trials in question had ended.
Before moving on, it is important to note that this isn’t just laziness or waste on the part of the medical research community. Getting a study published in an academic journal is not a particularly effortless thing to do, and papers can be stuck in review for months at a time–or even for years at the most competitive journals. The Yale researchers do discuss this point when elaborating upon their results:
Ross said that there may be many reasons for lack of publication, such as not getting accepted by a journal or not prioritizing the dissemination of research findings. Still, he said, there are alternative methods for providing timely public access to study results, including the results database at ClinicalTrials.gov that was created in response to Federal law.
Because the NIH funds such a substantial amount of medical research, a problem such as this essentially can be boiled down to the realization that Americans are paying taxes to support research and then are not being allowed to see the results of that research. Now, we can have conversations on the best methods of funding scientific research as a society, but it seems to me that if we are going to levy taxes to support it then we should make an effort to present the results of those studies to the public. This isn’t just a problem with unpublished studies, either: a lot of taxpayer funding goes to studies that are published, but then get locked behind the pay walls of privately run academic journals. In this case, Americans are able to see the research that they have in part funded, but only after they pay for it a second time.
I don’t have the answers to this problem, but I do think it is a problem, and I know that I’m not the only one. Open access advocates like Michael Eisen devote their blogs (as well as their lives) to this kind of thing, and they’ve got a lot of valuable things to say about it. If you’re interested, I’d recommend checking out Eisen’s blog. Derek Lowe over at the In the Pipeline blog also comments on this sort of thing from time to time, and, for those who may be interested in heterodox takes on funding for the sciences, Terence Kealey’s The Economic Laws of Scientific Research is a thrilling read.