Transparency and public accessibility to clinical studies greatly improved since 2005 when the ICMJE (International Committee of Medical Journal Editors) decided that no trials will be considered for publication unless they are included on a clinical trials registry.
Publication bias, i.e. the tendency of positive studies to be published and negative studies to be forgotten, however, seems to be a ongoing problem given some of the recent discussions and continues to hamper the scientific clinical evidence base.
Interestingly enough publication bias may even lead to an overstatement with respect to the difference in the degree of bias in industry and non-industry sponsored studies as Adam Jacobs indicated in his recent blog.
Also worth noticing in this respect is that unpublished data does not seem to be about negative outcome only: a recent publication in BMJ indicated that the direction of the effect of including unpublished trial data in meta-analyses varied; some meta-analyses changed to show more efficacy and some changed to show less efficacy of the drug.
Less than 50% of Clinical Trial Results Published
So how much clinical data is actually published? Numbers reported vary quite a bit, but I find it striking to read that despite improvements in publication, fewer than half of the trials funded by NIH are published in a peer reviewed journal within 30 months after trial completion.
Especially with the current health care market requiring an increasing clinical scientific evidence base while also demanding less expensive services, drugs, and devices, I wonder whether you as a medical device company can afford to spend millions of Euros in clinical trials without guarding the end result, i.e. a publication?
I know from my own experience, that besides the study results there are also other elements contributing to clinical study data not being published. What often happens is that the clinical project manager leading the publication effort moved on to the next clinical trial and is no longer driving for a publication, or that physicians are short of resources, i.e. time or money, to perform trial data analyses and publication next to their daily work.
Reflecting on the title of my blog: To me it seems that at least some improvement of the published clinical evidence base can be achieved by embedding a publication strategy and follow-up program in your strategic clinical evidence plan, and would increase your return on clinical investment. For medical device industry such publication strategy to my opinion should also include a grant program for supporting physicians interested to publish their clinical data in line with the overall clinical evidence plan.
If you like to exchange thoughts regarding the above or like some help with your publication strategy please feel free to contact me. Also I am planning to write in more detail about some of the elements in this blog, such as the need for publication, so stay tuned for future posts.