薬理と治療
2015, 43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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- 特集 臨床研究・臨床試験の信頼性確保への取り組み
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これからの倫理審査委員会を考える―「臨床研究に係る制度の在り方に関する検討会」における報告書の提言を手がかりに―
43巻Suppl 1(2015);View Description Hide Description -
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- Series
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EQUATOR Network から得られる,質の高い研究報告のための国際ルール④ PRISMA:システマティック・レビュー報告のためのツール
43巻Suppl 1(2015);View Description Hide Description - CONGRESS REPORT
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第 35 回日本臨床薬理学会学術集会シンポジウム「改正研究倫理指針に,医療機関・研究者はどのように向き合うべきか」
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- CASE REPORT
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最適化した疾患登録レジストリ・疾患データベース構築の取り組み
43巻Suppl 1(2015);View Description Hide DescriptionDisease registries/databases in the field of rare diseases are important since basic disease data necessary for clinical study planning can be obtained. However, many investigators using them have difficulties in securing labor and quality in data management and analysis. Our data center(DC)has supported a pediatric leukemia/lymphoma registry in linkage with clinical studies for more than 10 years, and our experience showed that their separation holds the key to effective data management and analysis. Therefore, we clarified known problems of disease registries/databases, and made efforts to optimize labor and quality by taking measures at the construction stage. On the basis of mock tables and figures that were expected to be generated at the time of completion of the paper, the principle investigator, biostatistician, data manager, and system engineer gathered together and undertook substantial discussions(Figure first). As a result, the initial plan to construct a single registry/database was changed, and it was finally separated into 3 parts:a disease registry, prospective observational study, and cross-sectional study. After their simultaneous initiation, cases were accumulated more rapidly than expected. These results suggest that the“Figure first”method allows the design of efficient clinical studies linked with a disease registry. -
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研究者主導臨床研究向け無償Electronic Data Capture システム「REDCap」を用いた Computer System Validationプロジェクトの事例報告
43巻Suppl 1(2015);View Description Hide DescriptionTo improve clinical research efficiency, it is necessary to utilize various information systems, including electronic data capture(EDC)systems. However, it is difficult to appropriately manage EDC systems in an academic institution because commercial EDC systems are often cost-prohibitive, and to safely and effectively manage EDC systems, network-level countermeasures and institutional-level activities are required. REDCap is one of the global, standard -free EDC systems for investigator-initiated clinical researches. Here, we introduce our REDCap and computer system validation project to improve the efficiency of clinical research. We developed a four-tier in-hospital network at our center according to the confidentiality level of the information associated with our institution. The tier-one demilitarized zone network was used to deploy the EDC system for multisite clinical research. The tiertwo network was used for ordinary research and administrative purposes related to the internet. Further, the tier-three network was used for clinical research databases and documents, and the tier-four network was for hospital information systems, including the electronic medical records system. We introduced the REDCap system at the appropriate infrastructure tiers. After introduction, we executed computer system validation using a validation plan, user requirement specification, confirmation of functional specification, and other validation measures that were created in our institution. In addition, standard operating procedures were established to execute the operation of the system and to maintain it appropriately. The REDCap system was introduced without major problems. We believe that introducing the REDCap system in institutions will improve the effectiveness of investigator-initiated clinical researches in Japan. -
国立国際医療研究センターにおける医学統計コンサルテーションに関する実施状況
43巻Suppl 1(2015);View Description Hide DescriptionThis article reports biostatistical consulting operation procedures at National Center for Global Health and Medicine, Tokyo, Japan, which were developed based on the results of a survey on biostatistical consulting at Japanese medical institutes. We show how we provide biostatistical consultation according to the standard operation procedures and also show consulting results from October 2013 to November 2014. -
被験者組入れ不良により中止された介入研究の失敗要因分析:事例検討
43巻Suppl 1(2015);View Description Hide DescriptionBackground Importance of Academic Research Organization in the area of clinical research has been increasing with the advance of building up of clinical study infrastructure in Japan. However, some studies could be terminated due to the insufficiency of subject recruitment. Objectives To find factors associated with the study failure due to insufficiency of subject recruitment by review of study management and interviews with staff. Methods A set of two studies of chemotherapy for multiple myeloma patients was analyzed. Review of studies was conducted based on the record of the studies. Four management staffs were interviewed. Results Review of studies and interview revealed five factors associated with study failure including principal investigator, role of management staff, co-investigator, protocol and trial design, and project management. Conclusions Factors associated with study failure were found by review of studies and interview. It is important to consider these factors at the planning of clinical study. - TECHNICAL TREND
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