One thing puzzles me about the dispute involving Procter and Gamble (P&G) and researchers at Sheffield University. According to the International Conference on Harmonisation guideline for good clinical practice:
"The sponsor should utilise appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports." It seems that P&G had such persons, but who was the statistician at Sheffield who was going to check the analysis? Was it a physician? In which case how far must this principle of collegial amateurism be extended? If I collaborate in medical research, will I have to spend time on the wards checking the doctors are getting it right?
Stephen Senn Glasgow University