In May 2014 Tom Treasure and his colleagues were able to publish the results of a trial completed 20 years ago involving 1447 bowel cancer patients. It was the first trial to be published under the RIAT (restoring invisible and abandoned trials) initiative announced last year.
Few people lived more than 5 years after being diagnosed with bowel cancer in the 1970s. Surgery to remove the tumour cured about half of the patients and doctors hoped that doing a follow-up surgery in patients with signs that the cancer had returned would save more lives. To test this theory, a group of researchers launched a large clinical trial in 1982 to determine whether people lived longer if they had this second surgery. 1447 patients enrolled in the trial in 58 hospitals across the UK. The trial was stopped in 1993 when it became clear that the additional surgery was not effective. The trialists never published their final results.
Treasure and a few of his colleagues were able to get access to the trial data and they decided to publish the trial using the RIAT initiative, which aims to allow researchers to publish other people’s trials that would otherwise remain hidden. Treasure’s team contacted the people who were initially involved in the trial to ask if they could publish it. None of the original trialists planned to continue work on the trial and they supported Treasure’s efforts to publish the findings. Treasure’s team was able to clean up the data (which had some formatting issues) and reanalyse the results. Their results confirm that the additional surgery did not improve the chance of survival. They end their paper by saying that if these findings had been published in 1994, doctors may have been more critical about using similar surgeries for liver and lung cancer patients.
The first RIAT publication has meant that the results of a trial with nearly 1500 people are now counted. More researchers are already working on publishing other trials under the RIAT initiative.
Read other stories of researchers publishing their old data in our recovered trials series.
Tom Treasure, Kathryn Monson, Francesca Fiorentino, Christopher Russell, The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer BMJ Open 2014;4:e004385. Full text
The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer BMJ Blogs 13 May 2014. Online
Peter Doshi, Kay Dickersin, David Healy, S Swaroop Vedula, Tom Jefferson, Restoring invisible and abandoned trials: a call for people to publish the findings BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2865 (Published 13 June 2013)
Operating to remove recurrent colorectal cancer: have we got it right?