THE CHALLENGE

Regional differences in clinical practice may affect interpretation of multi-country trials, which can delay local-level regulatory approvals. In a post hoc analysis of a registration study in prostate cancer, there was a significantly improved overall survival (versus placebo) in patient subgroups from Europe and those from North America. This is consistent with findings for the overall study population reported previously. Without any significant overall differences between the regional populations, was this analysis relevant to the urology community?

THE SOLUTION

We carried out further detailed analysis of the overall survival data and demonstrated that there were actually differences between the patient subgroups (longer median overall survival in both the treatment and placebo arms for the European versus the North American subgroups). These geographic differences were linked to regional differences in patient baseline characteristics and treatment patterns, and demonstrate that geographic differences in medical care can impact on the interpretation of clinical trial results. The next critical stage was for us to work with the authors to ensure that these thought-provoking results were published in the correct journal, for the most relevant audience.

THE OUTCOME

The British Journal of Urology International (BJUI) met all of our criteria. The BJUI not only accepted the manuscript, it showcased the information beyond the authors’ expectations, as the manuscript was selected to be “Article of the Week”. Additionally, an author video with summary slides was published on the BJUI website to enhance the health-care professional learning experience.