ABSTRACT

The investigator may wish to publish the results of the research because he feels the information is intrinsically interesting, needs to be communicated, or would enhance his (the investigator’s) reputation and status. The sponsor, too, is often keen to have the data published, particularly if the results reflect favourably on his product. On the other hand, many sponsors are rather reticent about having trial results published. The issue of publication should be discussed thoroughly during the contract negotiation phase with the monitor or preferably someone more senior; if possible, get a written undertaking about when and where to publish, and who should write the paper. The protocol or contract often contains a bland statement about the desirability of publication, even though the sponsor may actually have no intention of publishing the report, and some more specific agreement should be in place before the trial starts.