Summary
The TIDE trial continues to recruit patients despite a lack of clinical equipoise, exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator. It is almost certain that prospective study subjects are deprived of the opportunity to make a fully informed decision because the consent form does not present an accurate portrayal of existing safety concerns. It is difficult to imagine that a patient would willingly participate in a trial involving a drug that, according to the American Diabetes Association and its European equivalent, has safety concerns that leave it with no present-day role in the management of type 2 diabetes. The TIDE trial can only continue with the misplaced objective of proving definitive proof of what many studies have already suggested — that rosiglitazone is indeed more dangerous than pioglitazone. The price of such definitive proof will almost certainly be measured in the lives of study subjects who have been incompletely informed about the available evidence regarding the risks and benefits of participation.
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