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February 27, 2002

Patient Safety in Trials of Therapy for Acute Ischemic Stroke—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor

JAMA. 2002;287(8):987. doi:10.1001/jama.287.8.983

In Reply: The letter from Drs Goldstein and Albers further highlights the complexity of conducting clinical trials for acute ischemic stroke. Although the trial of aptiganel hydrochloride for acute stroke was designed and conducted by experienced investigators, an increase in morbidity and mortality was observed among patients receiving the highest dose of the study drug.1 This finding was unexpected given previous experience with the drug, thus emphasizing the importance of the DSMB. Although many trials do not halt recruitment of patients during interim analyses, most trials do not recruit patients at the rapid pace seen in the aptiganel hydrochloride trial. Inherent in the concept of an interim analysis is that the data can be used by the DSMB to determine whether the trial should continue or be halted for safety or efficacy reasons. There is seemingly little rationale for conducting an interim analysis if the interim data cannot be acted upon quickly. In the aptiganel hydrochloride trial, the phase 2 interim analysis of the first 300 patients prompted the DSMB to terminate the trial; yet during this time, another 328 patients were enrolled.