When authors get new data that revise a previous report, what should they do?
Experience suggests that it is preferable that an author send such a note on a published paper and even retract a paper, rather than a retraction being forced upon them (because other researchers have been unable to replicate their findings). Visit the second link (above) for an earlier Retraction Watch editorial that discusses the different consequences of an author taking such action rather than a forced retraction.
Shortly after the paper was published, a pharmaceutical company released new data showing the drug wasn’t quite as effective as it had seemed. Once the authors included the new data in their analysis, they adjusted their original response rate of 59% — hailed as one of a few “encouraging results” in an NEJM editorial at the time of publication — to 45%, as they write in the letter. One of the authors told us they published the 2015 paper using less “mature” data because the drug’s benefits appeared so promising, raising questions about when to publish “exciting but still evolving data.”
It’s not a correction, as the original paper has not been changed; it doesn’t even contain a flag that it’s been updated. But among the online letters about the paper is one from the authors, “Update to Rociletinib Data with the RECIST Confirmed Response Rate,” which provides the new data and backstory:
“In our Journal article that was published on April 30, 2015,1 we described the activity of rociletinib, an epidermal growth factor receptor (EGFR) inhibitor with specificity for the T790M mutation, in patients with EGFR mutation–positive lung cancer in the phase 1 TIGER-X trial. The key finding was a response rate of 59% (95% confidence interval [CI], 45 to 73) among 46 patients with biopsy-proven T790M-mediated resistance to previously administered EGFR inhibitors. In November 2015, Clovis Oncology issued a press release that contained updated data from a pooled cohort of patients from TIGER-X and TIGER-2 (another phase 2 study of rociletinib), stating that the rate of confirmed response was 28 to 34%.2 Since these response rates differed substantially, the academic authors of the Journal article undertook an independent updated analysis that included the patients whose data were reported in that article.”