Data and safety monitoring in the Concorde and Alpha trials. NLM AIDSLINE Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

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Data and safety monitoring in the Concorde and Alpha trials.

Control Clin Trials. 1999 Jun;20(3):207-28. Unique Identifier : AIDSLINE MED/99284387
Armitage P; St Peter's College, Oxford, United Kingdom.

Abstract: Concorde was a randomized trial to compare immediate and deferred zidovudine (AZT) treatment for persons with asymptomatic HIV infection. Alpha was a randomized trial to compare the efficacy of two doses of didanosine (ddI), in persons with symptomatic HIV disease who were intolerant of zidovudine. The two trials overlapped in time, and a single Data and Safety Monitoring Committee (DSMC) monitored accumulating data from both trials. This paper describes the deliberations of the DSMC and its recommendations to the parent steering committee during the course of each trial. In the discussion on Concorde, I draw attention to the problems of interpreting early survival data and trends in surrogate markers. With Alpha, interest focusses on the conflicting considerations that arose in discussions about possible termination at an interim stage.
Keywords: JOURNAL ARTICLE Acquired Immunodeficiency Syndrome/*DRUG THERAPY Anti-HIV Agents/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Biological Markers Didanosine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Double-Blind Method Human Randomized Controlled Trials/*METHODS/STATISTICS & NUMER DATA/ STANDARDS Survival Analysis Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USEKWDjournalarticleacquiredimmunodeficiencysyndrome/KWDdrugtherapyanti-hivagents/administration&dosage/adverseeffects/KWDtherapeuticusebiologicalmarkersdidanosine/administration&dosage/adverseeffects/KWDtherapeuticusedouble-blindmethodhumanrandomizedcontrolledtrials/KWDmethods/statistics&numerdata/standardssurvivalanalysiszidovudine/administration&dosage/adverseeffects/KWDtherapeuticuse
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