Simon Wessely writes on The BMJ Blogs his experience of finally publishing the results of a trial 17 years after completion. It serves as a good example of how trials can remain unpublished for so many years and what academics can do to get their abandoned trials published.
In 1995, Wessely’s team attempted to replicate a trial to determine the effect counselling had on people admitted to hospital who have problems with alcohol misuse. Wessely completed his trial on time and to budget and submitted the paper to The BMJ. It was rejected but the referees provided constructive comments. However, the project quickly fell to the back burner as the research grant had run out and the researchers moved on to different projects and jobs. They lost contact with one another and were left with an outdated draft and no access to the raw data.
After confessing to Iain Chalmers (one of the co-founders of AllTrials) at a Christmas party in 2011 that he had an unpublished study, Wessely decided to finally publish his trial.
Although we were unable to locate the data set, Jane Marshall (co-investigator) managed after a considerable effort to find the electronic copy of the manuscript, which included the revisions suggested by The BMJ and our responses. Neither of us, however, had the time (a familiar lament) to get the old manuscript into a presentable condition, nor to update the literature which had continued to expand in the intervening years, and now included several meta-analyses and a Cochrane review, albeit none of them including our trial, given that the authors did not have the gift of clairvoyance. And so I suggested we propose a Special Study Component for a King’s College London medical student, consisting of a project on non-publication of trials, linked to resurrecting and updating an example of the genre. And so we now had a new member of the team, medical student Celia Shiles. She got to work with gusto, updated the introduction and discussion, and carried out a meta-analysis to see how our trial would influence knowledge. And so 19 years after we wrote the grant, and 17 years after we finished the study, we submitted the trial to Trials.
The paper was published in the open access journal Trials in October 2013, meaning the efforts of the 154 people involved in the trial are now counted. Wessely’s story shows how academic delays and non-publication can be quite common and result from an “understandable and human sequence of events.”
Of course [these delays are] not ideal, but perhaps the most important thing is that the data from this trial are now available to all, and in a form that enables them to contribute to the next systematic review and meta-analysis in a subject that continues to be a very important public health problem […] We hope that others will now be persuaded to look into their own file drawers and see what lies there. It really is never too late.
Read other stories of researchers publishing their old data in our recovered trials series.
Shiles C, Canning U, Kennell-Webb S, Gunstone C, Marshall J, Peters T, Wessely S. Randomised controlled trial of a brief alcohol intervention in general hospital setting Trials 2013: 14; 345. Online.
Wessely, S. The lost trial – a Christmas story The BMJ Blogs 2013. Online.