A manuscript was submitted to our journal describing a clinical trial funded by a commercial sponsor with almost all authors being either employees or having financial ties to the company. Although generally favourable, during the extensive peer review process several reviewers raised concerns about the data being “too good to be true”. The editors sought additional statistical advice from two further statisticians, who felt there was no evidence of fraud. The paper was accepted.
Recently the journal received a phone call from X who wanted us to know that the company is aggressively touting its stock by saying it has a major paper that will soon appear in a prestigious journal. X also alleged that he had information raising further doubts about the conduct and validity of the study. Specific points were put to the authors, who refuted these.
What should we do now?
Should we be concerned? Should we do anything more? Although the results look very good, extensive review and enquiry has found no evidence of scientific fraud. Should we do nothing more and publish? Should we seek more evidence from the source of the allegations? Should we organise an independent investigation?
In this unusual case, some members of the Forum suggested that although the paper has been thoroughly reviewed, if the editor still suspects fraud then he should take steps to investigate it. Other suggestions were to ask X for his evidence that the conduct and validity of the study are flawed, with a deadline for an answer. If no answer is forthcoming, the paper should be published.
Thus the advice from Forum was that the editor has two options: (1) as there is no proof of fraud, the paper should be published but the editor should write an editorial explaining that although the results appear “too good to be true”, it has been extensively reviewed and analysed; (2) to definitely rule out fraud, ask the authors for the raw data and have the data thoroughly analysed.
We have asked the institution to examine the data and report back to us. They have agreed but we have had no other feedback as yet.
The Head of the institutions where the corresponding author was employed sent us a letter saying that he has full confidence in the author and in the author’s work and so we went ahead and published the paper. We regard this case as closed.