One approach to assigning authorship for a clinical trial

Make sure that you have identified the primary and senior author before the clinical trial has started — this is one of the of the better pieces of advice I have received from my mentors along the way. It makes for much less controversy when it is time to write up the manuscript. But who to put second, third, fourth and so on can still be a sticky subject, especially when you are dealing with a multicenter study.

I came across a recent article in Annals of Internal Medicine this month which presented a novel, but fair, way of assigning authorship based solely on effort ("Method for establishing authorship in a multicenter clinical trial"). This report is based on a cardiology study, the HF-ACTION trial, which examined the influence of exercise on death and hospitalization among patients with NYHA class II-IV heart failure. Participating sites received points for accrual, data completion and protocol compliance.

There was also a publication committee responsible for soliciting advice from participating investigators about possible manuscripts (for this large project, it ended up being a planned 22 papers). I think what appeals to me about this process is the transparency and the weight not just on accrual but on the quality of the data and the follow-up for the patients. Other large oncology clinical trials should consider adopting a similar approach for future studies.