We agree with Dr Holme that the figures on total mortality in the two arms of the HAPPHY trial should be published and refer to the letter that follows by members of the HAPPHY trial's Steering Committee.Dr Holme's second point refers to the effectiveness of treatment in relation to follow-up time in the MAPHY Study and the best method for its evaluation. Ethically, it is important in all trials to choose a statistical method with adequate sensitivity for detecting a clinically important difference between treatment alternatives in effectiveness. Before performing the main analysis, it is necessary, therefore, to discuss the pros and cons of different conventional tests. It is evident that the possibility of detecting a difference in treatment effect, if one exists, will be decreased by crossovers and dropouts. Experience from earlier long-term clinical drug trials has shown that increasing follow-up time will increase the impact
Olsson G, Tuomilehto J, Wikstrand J. MAPHY and the Two Arms of HAPPHY-Reply. JAMA. 1989;262(23):3272–3273. doi:10.1001/jama.1989.03430230044023
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