薬理と治療
2012, 40巻Suppl 1
Volumes & issues:
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日本臨床試験研究会雑誌
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- 扉・目次
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- SYMPOSIUM:第2回日本臨床試験研究会学術集会2011 in 大阪“臨床試験の国際化が進む中で日本が超えるべき障壁は何か”
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【シンポジウム 1 ● がん領域における国際共同試験の進め方】 抗がん剤の国際共同治験の現状と課題―外資系製薬企業の経験より
40巻Suppl 1(2012);View Description Hide Description -
【シンポジウム 1 ● がん領域における国際共同試験の進め方】 静岡がんセンターにおける国際共同試験の実施体制と課題
40巻Suppl 1(2012);View Description Hide Description -
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【シンポジウム 3 ● アカデミアにおける臨床試験サポート体制の現状】 大阪大学の臨床試験サポート体制
40巻Suppl 1(2012);View Description Hide Description -
【シンポジウム 3 ● アカデミアにおける臨床試験サポート体制の現状】 国立循環器病研究センターにおける臨床研究支援体制の現状
40巻Suppl 1(2012);View Description Hide Description -
- Series
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- Congress Report
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Annual Conference of Society for Clinical Data Management
40巻Suppl 1(2012);View Description Hide Description - REVIEW
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- ORIGINAL ARTICLES
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治験責任医師に添付文書改訂内容を伝える方法の検討
40巻Suppl 1(2012);View Description Hide DescriptionObjectives In spring 2010, revised package inserts with updated safety information of interferon(IFN)and ribavirin(RIB)provided for physicians including clinical investigators. This study investigated the way of providing information of revised package insert for clinical investigators. Methods We investigated the clinical trials with IFN and RIB in Hiroshima University Hospital from January to April in 2010. The Process for conveying information of revised package inserts of IFN and RIB were investigated by using the documents form sponsor to investigator. Results Ongoing clinical trials with IFN and RIB were 15 trials in January. In this study, 3 out of 15 clinical trials were revised Clinical Trial Consent Form by using Periodic Safety Update Report as precautions into the revised package insert. Three clinical trials was administering investigational agent during the implementation period. Clinical investigators had revised Clinical Trial Consent Form without using revised package insert information. Conclusions These results indicated that Clinical investigators should explain the reasons of the Clinical Trial Consent Form need amendment. -
日本の製薬企業における Electronic Data Capture 利用の実態に関する調査研究
40巻Suppl 1(2012);View Description Hide DescriptionBackground:Electronic Data Capture(EDC)system has been used to collect information in clinical trials. The proportion of trials using EDC in Japan was established to be lower than that in foreign countries. In 2007, we found the coverage of EDC was 34% in pharmaceutical companies of Japan. Some researches pointed out issues for introducing EDC, but follow-up surveys about EDC were scarcely reported in Japan. Objectives:To make the issues clear by comparing the results of research about the current usage situation of EDC with that in 2007. Methods:Structured questionnaire was delivered targeting both data management section in clinical development division and post marketing surveillance division of member companies of Japanese Pharmaceutical Manufacturers Association. Results:Among 102 respondents obtained, 56(55%)sections use EDC;the proportion was about 20 percent higher than that of the previous research in 2007. Out of 60 sections which have used EDC, 26(43%)sections have considered the case report form should be paper-based in the trials using EDC. One of the most important promoting factors for EDC was“to make EDC system cheaper”. Conclusions:We found the whole EDC coverage was much higher than the previous research, and that the most challengeable barrier was that EDC systems were relatively expensive. We revealed that the issues for introducing EDC at medical institutions were lack of infrastructure and security issue. -
高度医療評価制度下で実施する臨床試験の支援に関する研究―がん領域における多施設共同試験の課題―
40巻Suppl 1(2012);View Description Hide DescriptionThe Evaluation System of Investigational Medical Care(ESIMeC)is a new clinical trial system that Ministry of Health, Labour and Welfare authorizes the coverage of medical expenses by Japanese health insurance system for the patients participating in the approved clinical trials with high quality control mechanism. This system became effective in 2008. The Kitasato University Clinical Trials Coordinating Center has supported two randomized, phaseⅢ trials being conducted under ESIMeC since 2009. One trial is to evaluate the efficacy and safety of intraperitoneal (IP) chemotherapy of Carboplatin for ovarian cancer patients;another trial is to evaluate the efficacy and safety of new anticancer agent Bevacizumab for recurrent ovarian cancer patients. Carboplatin is approved for ovarian cancer by intravenous administration, but not for IP administration. Bevacizumab is not approved for ovarian cancer. However, the indication-directed trial has been completed for the first line chemotherapy for ovarian cancer, but not for the recurrent setting. In this article, we discuss the issues that need to be improved in the future, as well as the importance of the clinical trial coordinating center, so that ESIMeC will work better to accelerate investigator-initiated clinical trials evaluating new agents/medical techniques with no indication approval in Japan. Critical issues in cancer clinical trial coordination under ESIMeC include being familiar with the system itself, development of the clinical trial team, support of the application process for ESIMeC, establishment of serious adverse event reporting procedures, management of the study agents, and cost-effective study monitoring. - 会員連絡
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日本臨床試験研究会認定制度(新たな認定制度の実施)について/“臨床研究推進ガイドライン(案)”のパブリックコメント募集について
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