薬理と治療
2019, 47巻Suppl2号
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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- 日本臨床試験学会 第10回学術集会【これまでの10年,これからの10年】
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【シンポジウム1 ●臨床研究法において製薬企業が留意すべき事項およびその関わり方】 1 臨床研究法対応:研究者主導臨床研究の契約サンプル(多施設型)に関する解説
47巻Suppl2号(2019);View Description Hide Description -
【シンポジウム1 ●臨床研究法において製薬企業が留意すべき事項およびその関わり方】 2 臨床研究法における製薬企業等の関わり方(RACI の作成)
47巻Suppl2号(2019);View Description Hide Description -
【シンポジウム1 ●臨床研究法において製薬企業が留意すべき事項およびその関わり方】 3 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)
47巻Suppl2号(2019);View Description Hide Description -
【シンポジウム2 ●がんゲノム情報をもとに行う治験・臨床研究―実臨床での活用を見据えて】 ゲノム情報を活用する臨床試験のデザインと統計解析
47巻Suppl2号(2019);View Description Hide Description -
【シンポジウム3 ● 質の高い臨床研究実施のためのCRC とリサーチナースの効果的な活かし方―臨床研究法時代を迎えて】 1 リサーチナースの概念について
47巻Suppl2号(2019);View Description Hide Description -
【シンポジウム3 ● 質の高い臨床研究実施のためのCRC とリサーチナースの効果的な活かし方―臨床研究法時代を迎えて】 2 リサーチナースとCRC の協働の可能性
47巻Suppl2号(2019);View Description Hide Description - Original Article
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医師主導治験における標準業務手順書の適切な作成と効率的な運用に向けた検討
47巻Suppl2号(2019);View Description Hide DescriptionObjectives Standard Operating Procedure(SOP)is needed to conduct investigator‒initiated clinical trials. SOP templates for drug and medical device have been released on website, however, preparation processes for SOP depends on the institutions conducting a clinical trial. Moreover, no templates for regenerative medicine products are released. Here we created of SOP templates for regenerative medicine products, and also revised SOPs for drugs and medical devices. Methods First, we searched the notifications and guidelines relating investigator‒initiated clinical trials. Then SOP templates for drug and medical device were updated to reflect the latest notifications and guidelines as of the end of March 2019. Then, based on them, SOP templates of regenerative medicine products were made. Results The drug and medical device SOP templates were updated according to the 18 notifications and 7 guidelines from December 2012 to March 2019, and a regenerative medicine product SOP templates were newly created according to the latest notifications and guidelines as of the end of March 2019. Conclusions The SOP templates for drugs, medical devices and regenerative medicine products were created and released on the JMACCT website. They can be browsed and used by clinical trial personnel. These SOP templates can also be used as an education and training material. We hope that the proper use of these templates will help reduce or prevent deviations from GCP and regulations, and help achieve the quality control goals. -
jRCT(Japan Registry of Clinical Trials)を用いた特定臨床研究等の登録状況の実態調査
47巻Suppl2号(2019);View Description Hide DescriptionObjectives Although the Clinical Trials Act(the Act)was enforced in April 2018, the exact number of clinical trials(CTs)registered in the Japan Registry of Clinical Trials(jRCT)is unknown. This study investigates the CTs published in the jRCT and reports the actual condition of the registration status that has not clarified before. Methods We identified the specified CTs, etc. submitted by principal investigators for registration in the jRCT between the enforcement date of the Act and March 31, 2019. We extracted the data from jRCT at May 8, 2019 and used them for analysis of this study. We also obtained and used the data of the CTs registered in the University Hospital Medical Information Network between January 2010 and March 2019 to know the actual condition of pre‒enforcement and observation studies. Results The total number of CTs registered in the jRCT by principal investigators in the studied period was 1,145. Of these, 1,093(95.5%)were specified CTs, 38(3.3%)were non‒specified CTs, and 14 (1.2%)were registration‒directed or other types of CTs. The number of studies registered as non‒specified CTs was small. Among the 1,145 trials, 855(74.7%)were for drugs, 284(24.8%)for medical devices, and 6(0.5%)for regenerative medicine products. Of the target diseases registered in the jRCT in FY2018, 510(44.5%)were the oncology area, 619(54.1%)were the non‒oncology area, and 16(1.4%)were the CTs with healthy subjects. Conclusions The number of interventional studies decreased in the short term because the regulatory application procedures have become complicated and the application cost has increased due to the enforcement of the Act. Non‒oncology studies account for a larger portion of clinical trial registrations, and their study scales are smaller than those conducted during the transition period from the ethical guidelines. - Brief Report
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製薬企業におけるエビデンス創出に重要な知識・技能に関する横断調査
47巻Suppl2号(2019);View Description Hide DescriptionObjectives In pharmaceutical industry, the medical affairs(MA)department engage in the activities for creation of evidence, which consist of various designs. Thus, traditional knowledge and skills are insufficient for evidence creation in MA department. This survey was aimed to clarify key skills for evidence creation and to evaluate factors to contribute medical care through valid clinical evidence. Methods We sent questionnaires to 70 pharmaceutical companies subscribing to the Japan Pharmaceutical Manufacturers’ Association, and collected anonymously. Result The responses were obtained from 34 companies(48.6%). All 34 companies set up MA department, and conducted evidence creation in MA department. The average number of research areas was 4.5 areas. The most important skills for evidence creation was the highly ethical mind. The design of clinical studies, biostatistics and knowledge of public health were also considered as important skills for evidence creation. Needs for epidemiology and biostatistics in public health were great, and need for the 10 competency regions in public health was consistently high. Needs for 10 competency regions in public health and internationality were significantly related to the number of research areas. Conclusions In this survey, all company set up MA department, and engaged in evidence creation. The various skills including the highly ethical mind and the design of clinical studies were needed for evidence creation. In terms of public health, epidemiology, biostatistics and competency were regarded as key skills for evidence creation. - Case Report
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金沢大学附属病院の事例:臨床研究法に対応した研究計画書雛形とチェックリスト
47巻Suppl2号(2019);View Description Hide DescriptionInnovative Clinical Research Center, Kanazawa University(iCREK)has been disclosing a sample of protocol adapted to Clinical Trials Act and its checklist. This article reports the preparation of these documents. We hope to share the considerations in the preparation help clinical research planning in other clinical institutions. -
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「iPS 細胞由来ドパミン神経前駆細胞を用いたパーキンソン病治療に関する医師主導治験」での問合せ対応に関する報告:コールセンター業務からの考察
47巻Suppl2号(2019);View Description Hide DescriptionBackground Recruitment of trial participants is often difficult, and when recruiting, it may be necessary to respond to many inquiries. We recruited participants for the clinical trial using iPS cells for Parkinson’s disease. Parkinson’s disease is a refractory disease with a large number of patients, and iPS cell therapy is of great social interest. Therefore, many inquiries were expected when recruiting. Method We set up a website and a call center dedicated to the trial. We examined the number of inquiries from patients and others regarding this clinical trial, the content of inquiries, and the patient background. Result A total of 783 inquiries were made to Kyoto University during the dedicated call center setting period, of which 611 (78%)were handled by the call center. Total call time at the call center was 55.2 hours. The main contents of the inquiries were on how to participate in the trial, selection criteria, and registration period. Conclusion Many inquiries occurred in a short time when recruiting participants for a trial applying iPS cells to Parkinson’s disease patients. When conducting similar clinical trials in the future, centralizing the contact point to the call center is effective in order to avoid the influence on the normal operation in the hospital. -
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