—To estimate the lifetime benefits and costs of intensive therapy, we applied the results of the DCCT to the fraction of the US population with IDDM that fulfilled DCCT eligibility criteria.1,2 This conservative approach reflects the lack of extensive clinical trial data on the effects of intensive therapy in other IDDM populations. Nevertheless, evidence from other clinical trials suggests that intensive therapy is beneficial in patients with longer durations of IDDM at baseline than the DCCT participants and in patients with noninsulin-dependent diabetes.3,4 It is likely that many IDDM patients with relatively mild complications, regardless of age or duration, will have a similar benefit-to-risk ratio with intensive therapy as did the DCCT study population.An alternative research design that has been proposed for collecting health economic data within a clinical trial is the cost-effectiveness trial5 in which clinical trial protocol constraints are relaxed to examine the cost-effectiveness
Herman WH, Dasbach EJ, Songer T, Eastman R, Nathan DM. Cost-effectiveness of Intensive Insulin Therapy in the Diabetes Control and Complications Trial-Reply. JAMA. 1997;277(5):374–375. doi:10.1001/jama.1997.03540290026019
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