薬理と治療
2018, 46巻Suppl 2
Volumes & issues:
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日本臨床試験学会雑誌
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- 扉・目次
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- 特集【臨床研究法への対応】
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臨床研究法令を適切に運用するために(共同臨床研究等の検討)
46巻Suppl 2(2018);View Description Hide DescriptionObjectives This article aims to reveal actions and progress on the Clinical Trials Act in Japan. Especially we focused on research and configuration of contracts of clinical research for good operational procedures for medical institutions. Methods We reviewed criteria and notification about the clinical research. We identified factors that may effect on each type of contract. In addition, we extracted configuration of contracts and reality of situations between in Japan and in other countries to examine the rules of legislation regarding the clinical research under the rule of pharmaceutical industry in Japan. Results We focused on 4 points below, based on the patterns before the Clinical Trials Act coming into operation;1, classified configuration of contracts, 2, identified factors that may effect on each research contract and compare how legislation changes from conventionally style, 3, detail of the envisioned legislation and rules, 4, analysis of characteristics and characteristics extraction. We roughly grouped clinical research into two types, investigator‒initiated and company‒initiated. Role allotment between researchers and companies is summarized in Table1. Positive and negative lists along company’s function are shown in Table2. Conclusions We categorized the clinical research according to responsibilities, initiation and implementation. We assumed that the coauthor of the study, the clinical research organization may be considered desirable under the Clinical Trials Act. - 日本臨床試験学会 第9回学術集会
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【シンポジウム1 ●医療機器の臨床試験,何が難しい?】 実際の医療機器治験の実例から考える医師主導治験「全身性強皮症に伴う皮膚潰瘍に対する低出力体外衝撃波療法」を題材に
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【シンポジウム2 ●データベース/レジストリ研究,データシェアリングの現状と課題~これからの臨床研究開発・製造販売後安全性監視のあり方を考える!~】 1 電子診療情報を活用したこれからの医薬品安全性評価
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【シンポジウム2 ●データベース/レジストリ研究,データシェアリングの現状と課題~これからの臨床研究開発・製造販売後安全性監視のあり方を考える!~】 2 患者レジストリを薬事制度下で活用する際の「データの信頼性」の考え方(案)
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【シンポジウム2 ●データベース/レジストリ研究,データシェアリングの現状と課題~これからの臨床研究開発・製造販売後安全性監視のあり方を考える!~】 3 日本神経精神薬理学会の産学官連携活動におけるデータシェアリングの試み
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【シンポジウム3 ● 医療機関の長の業務を担う臨床研究事務局は機能しているのか?~キープレイヤーの存在とチームワークの重要性~】 1 医療機関の長の業務を担う臨床研究事務局の機能の現状と課題
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【シンポジウム3 ● 医療機関の長の業務を担う臨床研究事務局は機能しているのか?~キープレイヤーの存在とチームワークの重要性~】 2 倫理審査委員会の認定を取得した医療機関における臨床研究事務局の実際とは?
46巻Suppl 2(2018);View Description Hide Description - CONGRESS REPORT
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- SERIES
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海外文献紹介―① 臨床試験の統計解析計画書の内容に関するガイドライン Guidelines for the Content of StatisticalAnalysis Plans in Clinical Trials
46巻Suppl 2(2018);View Description Hide Description - Original Article
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がん領域における医療従事者の先進的な医療等に関する用語や制度の認識度と対応状況および支援体制に関する実態調査
46巻Suppl 2(2018);View Description Hide DescriptionRecent efforts of Japanese government have diminished the delays in marketing approval for new drugs; the government recommended that physicians must inform patients about investigational medical care as the next goal in the third Cancer Control Plan. The purpose of this study was to investigate the physicians’ and healthcare professionals’ awareness of 11 regulations and terms regarding advanced and investigational medical care, their experience with patient inquiries and difficulties, and their need for support systems of advanced and investigational medical care in oncology settings, by using an internet survey among 1042 healthcare professionals in clinical academic societies and cancer information and support centers in designated cancer care hospitals. We analyzed the differences in the above parameters among physicians, cancer information counselors, and other medical professionals. About 30% or less of healthcare professionals were aware of 8 out of 11 regulations and terms, and less than 20% were aware of the more recent regulations and terms. Cancer information counselors and other healthcare professionals were more experienced with patient inquiries than physicians. Similarly, cancer information counselors faced the most difficulties compared to other healthcare professionals and physicians. The recognition of current available support for healthcare professionals was associated with lower difficulties associated with patient inquiry. Healthcare professionals need all the seven support systems examined in this study, especially health professional support. A supporting environment is needed not only for patients but also among healthcare professionals. More studies are needed to elucidate how we establish a functional system to support patients and physicians. - Brief Report
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日本における医師主導治験の実施状況の分析とその求められる役割の検討
46巻Suppl 2(2018);View Description Hide DescriptionObjectives Fifteen years have passed since the investigator‒initiated clinical trial was institutionalized in Japan. This analysis was conducted to capture the entire picture of investigator‒initiated clinical trials conducted to date, and to determine relevant facts and characteristics. Methods Using clinical study registry databases (e.g., University Hospital Medical Information Network[UMIN], Japan Medical Association Center for Clinical Trials[JMACCT]), investigator‒initiated clinical trials in Japan were identified. Information on clinical trial notification and others was also extracted. These data were analyzed to determine annual changes in the number of trials, as well as trial characteristics such as developmental phase, design, new active ingredient or new indication, and target disease. Results Between January 2003 and August 2017, 235 investigator‒initiated clinical trials were identified. Of these, 82.1% were conducted in 2012 or later, and the annual number of trials increased from 2012 onward. PhaseⅡ accounted for 64.4%, but recent data showed an increase in PhaseⅠ trials(11 trials up to 2011 and 72 trials in and after 2012). In addition to trials for new indications of approved drugs(24 trials up to 2011 and 99 trials in and after 2012), seeding trials or trials of new active substances(15 trials up to 2011 and 94 trials in and after 2012)increased. Target diseases also have changed over time. Conclusions Recently, investigator‒initiated clinical trials have greatly increased and their contents have changed. This is presumably due largely to the influence of governmental policies including designation of core clinical research hospitals, and reorganization of pharmaceutical companies such as reduction of domestic development function in the age of globalization. -
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