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Microcomputer voice-response telephone entry for balanced clinical trial randomization

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Abstract

Simple randomization of patients to treatment regimens in clinical trials can result in inbalance among stratum categories. Procedures that produce balance may lack randomness. Systems that are not deterministic yet produce balance are often extremely complex and are not easily performed by randomization clerks. A microcomputer-based voice-response system has been implemented that permits clinic staff to easily randomize patients in clinical trials despite the complexity of the algorithm. Data entry is accomplished by the use of Touch-Tone® keys.§ Input prompts and regimen assignment are spoken by a commercially available voice synthesizer.

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Authors and Affiliations

  1. Department of Statistics, University of Wisconsin, 1210 West Dayton Street, 53706, Madison, Wisconsin

    Sunming Cheung, Steven M. Entine &  Jerome H. Klotz

Authors
  1. Sunming Cheung
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  2. Steven M. Entine
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  3. Jerome H. Klotz
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Additional information

Supported in part by DHEW, NIH, PHS Grant No. 5 P30 CA 1452A 20-05, Mod, 1.

Supported in part by DHEW, NIH, PHS Grant No. 5 R01 CA 18332-02.

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Cheung, S., Entine, S.M. & Klotz, J.H. Microcomputer voice-response telephone entry for balanced clinical trial randomization. J Med Syst 1, 165–169 (1977). https://doi.org/10.1007/BF02285283

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  • DOI: https://doi.org/10.1007/BF02285283

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