Bringing old trials to light in BMJ Open

 

Today we have published the first trial prompted by the Restoring Invisible and Abandoned Trials (RIAT) initiative.

Dr Tom Treasure from UCL, with colleagues from University of Sussex and Imperial College, have brought back from obscurity the results of the ‘CEA Second-Look’ trial.

The study asked the question: in patients who have undergone a potentially curative resection of colorectal cancer, does a ‘second-look’ operation to resect recurrence, prompted by monthly monitoring of carcinoembryonic antigen, confer a survival benefit?

As well as the inherent clinical significance of the study to colorectal surgery the paper is important in the context of the AllTrials and RIAT initiatives to bring greater transparency to the conduct and reporting of clinical trials.

We are delighted that this paper has been published in BMJ Open and you can read more about the background to the paper’s preparation in an accompanying Analysis piece in The BMJ.

We are enthusiastic supporters of the AllTrials campaign (BMJ was a founder). We encourage submission of so-called negative results, such as this trial of weekly chloroquine therapy for malaria-associated anaemia. These papers may show genuine evidence of absence of an effect, but they may also report trials that were inconclusive (reporting an absence of evidence).  Results of trials that had to shut down early, perhaps due to recruitment problems or unexpected side-effects will also be considered. As well as RIAT trials, trials that just happen to be old are also important to publish. We also publish trial protocols and research into trial methods.

For many years The BMJ has campaigned for all trial results to be published and the creation of BMJ Open in 2010 was intended, in part, to provide a venue for trials that may struggle to be published by journals looking only for definitive, new or positive results.

Unfortunately, we also have to turn away some trials that are submitted to BMJ Open.

Before sending any trial or trial protocol for review we check the registration details. We follow rigorously the International Committee of Medical Journal Editors’ recommendations that trials should be registered prospectively, i.e. before any participants are recruited. Unfortunately we receive several studies every month that fail this check and are rejected. Doubtless they’ll end up published somewhere, but that is where we set the bar for ethical and methodological soundness of trial conduct.

If you have any questions about whether your study is suitable for BMJ Open, or about trial registration, please contact the editorial office at editorial.bmjopen@bmj.com. We would be delighted to hear from you.

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