The process of obtaining informed consent and engaging in shared decision making with patients involves conveying information about the reasonable effectiveness of proposed treatment, as well as its risks and benefits. This can be particularly difficult with respect to regenerative and stem cell therapies, as this is an area of medicine that currently lacks substantive data on efficacy. Generation of relevant data and evidence has not occured to a sufficient  enough degree and this is often blamed on the difficulty involved in organizing large-scale, randomized controlled trials as part of the approval process for novel therapies. However, the FDA has recently argued that a statistically significant 100% improvement in an outcome measure may be detected with a randomized trial involving as few as 42 participants.