In 2003, the President of the United States introduced a now often used phrase into the American lexicon, “Mission accomplished” (1). While history has not judged, to the greatest of degrees, his proclamation with favor in terms of its accuracy, the idiom does seem a fitting response to the letter by Sanda and Greenbaum (2), written in reaction to my editorial (3). This claim can effectively be made as their action is exactly what I hoped would occur: an open discourse…a debate, on how trials to reverse type 1 diabetes are designed and performed. For this, I am grateful and hope that more opinions such as theirs come forward, both in written as well as verbal form at scientific meetings, consistent with the stated goal of the editorial (3).
To be clear, my intention was not to convey a message that placebo-controlled trials should be outright discarded without discussion, but rather that the concept of trial design, including those involving either a universal control or an adaptive trial design, be subject to more active consideration rather than our just continuing the ways of history because, as so much of life operates, “It has always been done this way.” To my belief, each of the contrarian arguments noted in the letter by Sanda and Greenbaum (2) were, in fact, presented within the editorial (3)—notions placed into the prose for the purpose of providing intellectual balance. Yet, in the end, if the intended degree for my providing a balanced viewpoint was inadequate, the letter of Sanda and Greenbaum will, hopefully, address any such shortcoming.
Finally, I join with these authors (2), as noted in the editorial (3), that efforts like the National Institutes of Health (NIH) TrialNet are without question advancing the pace of clinical trials. I also acknowledge this issue of trial design is not new to that group, having been subject to previous consideration by them. Also as noted in my editorial (3), the model should be tested, and NIH TrialNet would certainly be in an ideal position to test it. That being said, I remain confident in my belief that the number of subjects making their way into such research trials represent the vast minority of persons in the U.S. eligible for these efforts based on typical entry criteria. Hence, I would once again portend that we need to explore new avenues and novel thought processes routinely and often to increase recruitment…and not for the matter of mere emotions but because we must do a better job at what we do.
No potential conflicts of interest relevant to this article were reported.