Unpublished Trials Amnesty

Come and join our unpublished trials amnesty

If you have an unpublished randomised controlled trial (RCT) or parts of an unpublished randomised controlled trial dealing with interventions for skin diseases in humans, please send it to us so that it can be used for the greater good of mankind.

Why are we doing this?

We believe that all randomised controlled trial data conducted on humans should belong to the people, i.e. the data should be accessible in the public domain. It is only when we view the totality of data, that we are able to obtain a fair picture of what is going on with a particular intervention.

Why are RCT studies not published?

For a variety of reasons, some benign and some malign. Perhaps the most common reason is the lack of time and effort, eg. the investigator was a busy clinician who was not able to complete the study, and has since moved on and has not had any time to complete the write-up or submit the study for publication in a peer reviewed journal. Sometimes, the dermatology journals give the authors a hard time in publishing their study, and after 2 or 3 attempts, the authors may give up trying to publish the study. Sometimes data is deliberately concealed or delayed for publication by investigators and the pharmaceutical industry in order to obtain an intellectual or commercial advantage, and this is something we wish to overcome.

Why bother publishing small inconclusive RCTs that didn't make it to a journal?

The most important reason is for people conducting systematic reviews of an intervention for skin diseases to include all possible evidence for that intervention. It has been shown in numerous studies that a publication bias occurs for RCTs. That is studies with 'positive findings' tend to be published far more commonly and quickly than those with 'negative' or inconclusive findings. By only including such positive studies, a systematic review may end up with a biased overall estimate of the treatment's beneficial effects whilst ignoring the hidden data from other studies. Nearly all studies, however small, contain some useful data. Sometimes, the study contains useful information on adverse events, some contain useful data on new methods, some contain useful data on the variability of outcome measures, and whilst the results of the RCT may be inconclusive in itself, it may provide some essential data for new clinical trialists to plan the next study.

If a study is published on the Cochrane Skin Group site, does it mean it is a good study?

Not necessarily. The studies that are published in this section are not peer reviewed, and the inclusion or otherwise of a study in this section in a systematic review is the responsibility of the reader/reviewer. Apart from studies that appear clearly unethical, we will undertake to publish all studies submitted to us for this section.

How do I submit my study?

Please send it to the Cochrane Skin Group (csg@nottingham.ac.uk) in whatever format you can, and we will add it to the repository.