臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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41 巻, 3 号
選択された号の論文の24件中1～24を表示しています
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特集／臨床試験とバイオマーカー
  • 巻頭言
    渡邉 裕司
    2010 年 41 巻 3 号 p. 89
    発行日: 2010年
    公開日: 2010/07/23
    DOIhttps://doi.org/10.3999/jscpt.41.89
    ジャーナル フリー
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  • １．動脈硬化性疾患のバイオマーカー
    植田 真一郎
    2010 年 41 巻 3 号 p. 90-94
    発行日: 2010年
    公開日: 2010/07/23
    DOIhttps://doi.org/10.3999/jscpt.41.90
    ジャーナル フリー
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    The principal aim of the intervention against established cardiovascular risk factors including hypertension, dyslipidemia and diabetes is the prevention of atherosclerotic cardiovascular event. Indeed there is no doubt that reduction of blood pressure, for example, is associated with better outcome. However, achieved of blood pressure does not necessarily reflect regression of atherosclerosis. Blood pressure as well as other risk factors, therefore, may not be suitable for the assessment of progression of atherosclerosis particularly at the early stage. Although the criteria of surrogacy is not easily satisfied, surrogate markers that integrate risk factors and more directly reflect development of atherosclerosis are warranted in clinical practice for individual patient as well as in early phase clinical trial of anti-atherosclerotic therapy.
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  • ２．がん分子標的治療のバイオマーカー
    西尾 和人
    2010 年 41 巻 3 号 p. 95-100
    発行日: 2010年
    公開日: 2010/07/23
    DOIhttps://doi.org/10.3999/jscpt.41.95
    ジャーナル フリー
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    Molecular target therapy constitutes an essential component of standard cancer therapy of the 21st century. Hence the importance of biomarkers and their research are growing. Biomarkers are used for risk assessment, early detection, prediction of prognosis and surrogate endpoints. Biomarkers are also essential for the development of personalized medicine. Many biomarkers are biological substances related to normal tissues including the stroma, vessels as well as tumor tissues. Omics technology is also being used worldwide.
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  • ３．脳神経疾患におけるバイオマーカー
    岡村 信行, 谷内 一彦, 古川 勝敏, 荒井 啓行, 工藤 幸司
    2010 年 41 巻 3 号 p. 101-106
    発行日: 2010年
    公開日: 2010/07/23
    DOIhttps://doi.org/10.3999/jscpt.41.101
    ジャーナル フリー
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    Biomarkers play an important role in the study of neurological disease. In neurodegenerative disease, the pathophysiologic process leading to neuron death begins before clinical symptoms develop. Therefore, one of the most important roles of biomarkers is an accurate diagnosis of diseases in their early and presymptomatic stages. Another important role of biomarkers is to serve as potential surrogate markers of disease severity. Biomarkers can also be used to improve safety assessment and determine appropriate dosage of the drug. Various biomarkers have been developed for clinical assessment of Alzheimer's disease. Tau and amyloid-β protein in cerebrospinal fluid are useful biomarkers for early diagnosis of Alzheimer's disease. Recent development of molecular imaging probes enables noninvasive detection of amyloid plaques using positron emission tomography (PET). PET amyloid imaging may be useful for early and accurate diagnosis of Alzheimer's disease, patient selection for disease-modifying therapeutic trials, and monitoring of the effect of anti-amyloid therapy. A multisite, prospective clinical study was launched to develop standardized neuroimaging and biomarker methods for clinical trial on Alzheimer's disease.
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  • ４．製薬企業におけるバイオマーカーの活用
    劉 世玉
    2010 年 41 巻 3 号 p. 107-112
    発行日: 2010年
    公開日: 2010/07/23
    DOIhttps://doi.org/10.3999/jscpt.41.107
    ジャーナル フリー
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    Drug development projects have high attrition rates, often because efficacy and safety issues have not been foreseen. The FDA Critical Path Opportunities list highlights prominently developing and qualifying biomarkers that enable rational decision-making early in development, allow the potential for increased efficiency, as well as resource and time savings. Biomarkers have found utility in many aspects of drug development and medical practice. Regarding the potential for molecular diagnostics to be used as companion products for personalized treatments, the idea of a forthcoming Rx/Dx co-development guidance was floated in a 2005 white paper, which industry observers criticized as too idealistic and out of step with the challenges of managing competing interests and aligning of divergent drug and diagnostics development timelines. In October 2006, a biomarker consortium founded by the FDA, the Foundation for the National Institutes of Health, and the Pharmaceutical Research and Manufacturers of America was launched, which is a visionary first step to pooling resources, standardizing approaches, and instituting collaborations across public and private sectors to facilitate discovery and application of biomarkers to achieve truly individualized patient care. In addition, for the safety of biomarkers, collaboration across the industry and academic researchers has jointly established the Serious Adverse Events Consortium (SAEC) in August, 2007. In this article, the current status of biomarkers in Japan is summarized, including the results of a survey conducted by JPMA and the activities of the Japan Data Science Consortium (JPDSC)founded by six pharmaceutical companies in February 2009 with the objective to reduce adverse events by a study framework for genome-wide association of adverse events in Japanese population.
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フォーラム
  • 研究倫理審査委員会の現状と改善策の提案　―ある施設における臨床研究を対象とした平成18年度の審査過程の調査及び委員，申請者の意識調査より―
    鈴木 美香, 佐藤 恵子
    2010 年 41 巻 3 号 p. 113-124
    発行日: 2010年
    公開日: 2010/07/23
    DOIhttps://doi.org/10.3999/jscpt.41.113
    ジャーナル フリー
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    A research ethics committee (REC) is an appropriately constituted group that reviews and monitors biomedical research in order to protect the rights and welfare of human subjects. Although a number of studies have reported that Japanese institutions conducting biomedical research have established RECs, little is known about the quality of research protocols and the review process in these institutions.
    Using a checklist of 67 items, we reviewed 75 protocols that had been evaluated by the REC of an institution. Forty-six of 75 protocols did not clearly state the background of the study. In 25 of the 46 protocols, no committee members identified the absence of a stated background. Interviews with 18 investigators and 27 REC members revealed that some investigators and committee members did not understand the role of the REC.
    The results of this study suggest that about one-third of REC-approved protocols may contain shortcomings. The study implies that REC does not always function effectively to ensure that the research to be conducted is ethically sound. We suggest the following improvements: 1) education and training of investigators and committee members on how to conduct clinical research, 2) establishment of a research center to support and manage the conduct of clinical research, 3) improvement of relationship and communication between committee members, 4) introduction of a procedure whereby all committee members discuss each protocol until a consensus is reached, and 5) establishment of an organization to support efficient and effective operations of the RECs.
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第30回日本臨床薬理学会年会記録
シンポジウム 9 　　わが国における臨床研究スタッフのあり方を考える　―SCRP（Senior Clinical Research Professional）をめぐって
シンポジウム14　　大規模臨床試験の基盤整備：ルール・ファンド・利益相反
シンポジウム15　　ファーマコゲノミクスの現状と課題
ワークショップ 2 　ジェネリック医薬品：多様化する選択肢の中でどう選ぶか
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