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Competing Perspectives on PROactive

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In his commentary on the conduct of the PROactive Study (Clinical Diabetes 24:63-65, 2006), Dr. Jay Skyler reiterated his opinion of misconduct by some or all of the study statisticians, the members of the Data Safety and Monitoring Committee (DSMC), or the overall study chairman and his steering committee, and specifically that they colluded in suggesting a new principal secondary end point, having prior knowledge of the study's primary end point likelihood.^1,2 By so doing, he impugns yet again the scientific integrity of all of the above. Despite our earlier unequivocal refutation of his allegations,³ we feel that his continued onslaught once again calls for an absolute and transparent rebuttal of his allegations.

Throughout the study, blinded patient data . . . [Full Text of this Article]

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