Treatment trials, prevention trials, diagnostic trials, expanded access trials, screening trials and quality of life trials. Safe dosage range, identification of side effects, comparison to commonly used treatments, post-marketing studies, and of course the placebo comparison. Every new drug that hopes to get to market has to undergo it all. Eventually we should be able to know what every new drug can and cannot do. Ideally, only the effective drugs -- the ones that do exactly what they say on the label and nothing more -- make it to the end. In this process, a wealth of information is gained. Unfortunately, for the drugs that don’t make it all the way to the end, a lot of vital information is also lost.
A recent study entitled “Time to publication for results of clinical trials” has highlighted the need to publish the bad as well as the good from clinical trials, an effort supported by the World Health Organisation. Clinical trials showing a positive treatment effect, or those with important or striking findings, were much more likely to be published in scientific journals than those with negative findings. Researchers at the Cochrane Centre set out with the objective to investigate if publication of clinical trials was influenced by the result obtained (positive or negative) and to what extent does the significance of the outcome influences the publication. The more striking results get published quicker, and are also more likely to get published. Positive results in favour of the treatment hypothesis were published within 5 years, while the so-called “silent evidence” goes unpublished for many years. Trials with null or negative results were only published after about 6 to 8 years. Possibly, due to the fact that additional time is needed for follow-up trials and studies. This, of course, points out the way we view positiveness in our data. Often follow-up studies would be done to glean some positiveness to an otherwise negative result.
In the end, the wealth of information -- the systematic review -- on a particular drug or treatment will be incomplete, adversely affecting the evidence for decision and policy making. The importance of such a grand question has been known for some time. And such, making sure the bias in the science we do is put forward to create a clearer picture as possible.
Written by Dr. Charles Ebikeme for The All Results Journals.
NOTE FROM DAVID ALCANTARA: Please leave your best ideas about publication bias and how a journal of negative results can help to fight the bias below in the comments. Please try to write up something with some value and contribute to this conversation with an insight, a practice, or a resource that we can all use to create more value. Thank you!