ALT In hindsight, one might call into question whether it was advisable to pursue this line of investigation in the first place. Each clinical trial must be conducted only when there is a sound scientific foundation underpinning the research and following careful consideration of the potential risks vs the potential benefits for patients. Patient volunteers must not be subjected to the demands, inconvenience, and risks of a clinical trial without a compelling reason to believe they may benefit. There is also the consequential matter of resource allocation, since federal research dollars are ultimately zero sum. Did TACT and TACT2 meet these requirements?

ALT It is not the purpose of this note to proffer a value judgment about the original decision to pursue this research because this is a complex, multifaceted question that requires in-depth review and deliberation. Although this question is beyond the scope of this note, the matter is nevertheless worthy of thoughtful consideration by the wider cardiology research community. There may not be a bright line, but the implications for the clinical research enterprise merit careful attention. Common sense dictates that not all hypotheses need be subjected to a clinical trial.