Ethical issues in oncology biostatistics.

A medical statistician's routine professional activities are likely to have important ethical consequences. This is due in part to the fact that good medical practice and scientifically valid medical research both require as precursors high quality statistical design and data analysis. In this paper I discuss various ethical issues that I have encountered while working as a biostatistician at M.D. Anderson Cancer Center. I describe particular experiences and the ethical issues involved. Topics include medical decision making, benefit-harm trade-offs, safety monitoring, adaptive randomization, informed consent, and publication bias.