Stopping the active intervention: CARET.

Deborah J Bowen; Mark Thornquist; Karen Anderson; Matt Barnett; Corinne Powell; Gary Goodman; Gilbert Omenn; Carotene and Retinol Efficacy Trial

doi:10.1016/s0197-2456(02)00277-5

PubMed · 12559641

Stopping the active intervention: CARET.

Deborah J Bowen·Mark Thornquist·Karen Anderson·Matt Barnett·Corinne Powell·Gary Goodman·Gilbert Omenn·Carotene and Retinol Efficacy Trial

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Abstract

The Carotene and Retinol Efficacy Trial (CARET) was a large, multicenter randomized chemoprevention trial designed to test a combined lung cancer prevention agent in heavy smokers and workers exposed to asbestos. In January 1996, the CARET Steering Committee decided to stop the intervention due to an adverse effect. This paper describes the decision process used to apply the stopping rules and the activities engaged in by CARET participants and staff to implement the decision. The most important activity was to draft and mail a letter to the participants informing them of the disappointing CARET results and asking them to stop taking the study vitamins and to return any unused study vitamins. The steering committee, with the support of the National Cancer Institute, planned to follow participants for disease endpoints and smoking behavior for 5 years. These activities led to smooth closure of active intervention and maintained high retention rates during the transition.

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Asbestos Chemoprevention Clinical Trials Data Monitoring Committees Data Interpretation, Statistical Drug Evaluation Ethics, Medical Humans Lung Neoplasms Occupational Exposure Randomized Controlled Trials as Topic Smoking Therapeutic Human Experimentation United States Vitamin A beta Carotene Journal Article Research Support, U.S. Gov't, P.H.S.

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Deborah J Bowen, Mark Thornquist, Karen Anderson, Matt Barnett, Corinne Powell, Gary Goodman, Gilbert Omenn, Carotene and Retinol Efficacy Trial. 2003. Stopping the active intervention: CARET.. https://doi.org/10.1016/s0197-2456(02)00277-5

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