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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
pharmacology, toxicology and pharmaceutics
Termination of a randomized controlled trial of two vasectomy techniques
Controlled Clinical Trials, Volume 24, No. 1, Year 2003
Notification
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Description
Family Health International (FHI) and EngenderHealth conducted a multicenter, randomized controlled trial to evaluate a fascial interposition (FI) component of a vas occlusion procedure for male sterilization. A data monitoring committee (DMC) was established to provide independent review of the interim report. The DMC met to review the interim report after enrollment of 552 men. As planned, an estimate of the hazard ratio (HR) for successful vasectomy for the FI group versus the no-FI group controlling for age of the participant and level of experience of the surgeon was obtained for the interim report using Cox's proportional hazards regression. The main analysis comparing time to vasectomy success, defined as two consecutive azoospermic semen samples, was highly significant and met the prespecified level for stopping enrollment (HR=1.54, p<0.01). However, a troublesome age by vasectomy technique interaction became apparent in the analysis. FI was clearly beneficial for younger males. However, the trend for older men was not as clear. The DMC recommended continuing the trial to better study this interaction and obtain more data to clarify the effect of FI for older men. After consulting further with the DMC, the study statisticians presented the interim report to senior management at FHI. A meeting between FHI senior management and the DMC followed. After much deliberation, trial enrollment was terminated. Follow-up of participants already enrolled in the study continued as planned. This paper presents the issues involved in the decision to terminate the study. © 2003 Elsevier Science Inc. All rights reserved.
Authors & Co-Authors
Chen-Mok, Mario
United States, Durham
Fhi 360
United States, Research Triangle Park
Biostatistics Branch
Bangdiwala, Shrikant I.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Dominik, Rosalie C.
United States, Durham
Fhi 360
Hays, Melissa A.
United States, Durham
Fhi 360
Sokal, David C.
United States, Durham
Fhi 360
Statistics
Citations: 31
Authors: 5
Affiliations: 3
Identifiers
Doi:
10.1016/S0197-2456(02)00267-2
ISSN:
01972456
Research Areas
Environmental
Study Design
Cohort Study
Study Approach
Quantitative
Participants Gender
Male