Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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Volume 45, Issue 1
Displaying 1-8 of 8 articles from this issue
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Original Article
  • Stopping Rules for Continual Reassessment Method Using Both Efficacy and Toxicity Endpoints
    Shinjo YADA, Chikuma HAMADA
    2014 Volume 45 Issue 1 Pages 3-10
    Published: January 31, 2014
    Released on J-STAGE: February 21, 2014
    DOIhttps://doi.org/10.3999/jscpt.45.3
    JOURNAL FREE ACCESS
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    The continual reassessment method (CRM) is a sequential design for phase I clinical trials. The CRM updates the model parameter of dose-toxicity relationship using the accumulated data, and selects the estimated maximum tolerated dose (MTD) as the dose used in the next cohort. In some situations, however, it is necessary to select the appropriate clinical dose considering both efficacy and toxicity. Recently, many methods for selecting the dose with the highest utility considering both toxicity and efficacy have been proposed. Although a trial is to be terminated when the response rates at all doses are very low or estimated toxicity is very high, no other formal and quantitative stopping rules have been proposed. From the ethical and economic viewpoints, it is desirable to halt the trial early if the necessary information about efficacy and toxicity is available. The design proposed by Thall and Cook (2004) is a CRM that considers toxicity and efficacy simultaneously. Adopting this design, we propose a rule to stop a trial if the Bayesian confidence interval of the predicted benefit in the next cohort lies within a given range. Computer simulations show that this proposed method allows early stopping compared to the conventional method, without greatly reducing the percentage of correct selection of the optimum dose. Even when there is misspecification of the efficacy-toxicity trade-off contours, the proposed method recommends the optimum or a safer dose.
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Short Communication
Forum
  • Inalienable Right to Withdraw from Study and the Point of No Return in the Context of Biobank Research
    Kenji MATSUI, Kuniko AIZAWA, Akiko TAMAKOSHI
    2014 Volume 45 Issue 1 Pages 17-23
    Published: January 31, 2014
    Released on J-STAGE: February 21, 2014
    DOIhttps://doi.org/10.3999/jscpt.45.17
    JOURNAL FREE ACCESS
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    Research participants are generally granted the freedom to withdraw from participating in a medical research at any time without providing any reason. However, this generally accepted practice of allowing participants the inalienable right to withdraw is not necessarily an ethical requirement. Ethics provides room to restrict a participants' freedom to withdrawal under certain conditions. Taking into consideration the current state of consent withdrawal in actual biobanking research and the possibility of eliminating any reliance on researchers' discretion, it is more appropriate both ethically and practically to limit the duration to 6 months in which participants are guaranteed the inalienable right to withdraw from a study.
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Proceedings of the 34th Annual Meeting of the Japanese Society of Clinical Pharmacology and Therapeutics
"Introduction of Novel Therapeutics against Cardiovascular and Metabolic Diseases: From Bench to Bedside"
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