This paper by David J. Stewart, et al, first published in the Journal of Clinical Oncology: Volume 28, Number 17 (June, 2010), discusses how current approaches squander research resources and discourage research participation, and the marked imbalance between potential life-years lost versus saved renders the regulatory burden potentially unethical.  Stewart, et al. discuss suggested solutions.

Access the full article at http://ascopubs.org/doi/full/10.1200/JCO.2009.27.5404