臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
45 巻, 1 号
選択された号の論文の8件中1~8を表示しています
原著
  • 矢田 真城, 浜田 知久馬
    2014 年 45 巻 1 号 p. 3-10
    発行日: 2014/01/31
    公開日: 2014/02/21
    ジャーナル フリー
    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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フォーラム
  • 松井 健志, 會澤 久仁子, 玉腰 暁子
    2014 年 45 巻 1 号 p. 17-23
    発行日: 2014/01/31
    公開日: 2014/02/21
    ジャーナル フリー
    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.
第34回 日本臨床薬理学会学術総会 記録
日本薬理学会・日本臨床薬理学会 共催シンポジウム「循環器・代謝性疾患の新規治療薬:基礎から臨床へ」
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