薬理と治療

2022, 50巻Suppl 1
Volumes & issues:
-
日本臨床試験学会雑誌 23
-
- 扉・目次
-
- 日本臨床試験学会 第13回学術集会 臨床試験による創造と変革 Change the world better through clinical trials, together! 【特別シンポジウム】これからの臨床試験・臨床研究はどうあるべきか
-
扉 日本臨床試験学会 第13回学術集会 臨床試験による創造と変革 Change the world better through clinical trials, together! 【特別シンポジウム】これからの臨床試験・臨床研究はどうあるべきか
50巻Suppl 1(2022);View Description
Hide Description
-
特別シンポジウム『これからの臨床試験・臨床研究はどうあるべきか』について
50巻Suppl 1(2022);View Description
Hide Description
本セッションは,長年日本臨床試験学会の代表理事を務められ,2020 年に逝去された大橋靖雄先生の数々の功績のなかから,本学会にも縁がある有識者を招き,日本臨床試験学会が進んできた過程を振り返り,今後の進むべき方向性について最新の知見を持って議論するために企画された。プログラム順に概要を説明する。 -
1 治験,臨床研究の教育とJSCTR 認定制度について
50巻Suppl 1(2022);View Description
Hide Description
本稿は第13 回日本臨床試験学会学術集会特別シンポジウムの口演記録であるが,すでに「大橋先生と日本臨床試験学会の10 年の歩み」など,口演発表と類似した内容をいくつかの雑誌に掲載しているので,特別シンポジウム口演記録として,その後の臨床試験の情勢変化を含めて現在考えていることを記載する。 日本の臨床研究の現状については著者が書いた論文をご参照いただきたい1),2)が,特定臨床研究の数は横ばいであるが,新倫理指針における介入研究数は減少している。日本臨床試験学会などで,厚生労働省医政局研究開発振興課から「臨床研究法及び人を対象とする生命科学・医学系研究に関する倫理指針改正のポイント」の解説をいただき,現場からの疑問について質疑応答の時間を設けていただいた。しかし,残念ながら「人を対象とする生命科学・医学系研究に関する倫理指針」,「デジタル社会の形成を図るための関係法律の整備に関する法律(令和3 年5 月19 日法律第37 号)に関しては,アカデミアのほとんどで理解が浅く,弁護士の方のセミナーが多く開催され,個人情報保護法および学術研究機関の運用については混乱をきたしている。本学会でもセミナー「第8 回倫理審査委員会を考える!」が今後計画されている。 また,海外論文を書いてみて経験したが,論文が採択されるためには,患者・市民参画(PPI: patient and publicinvolvement:医学研究・臨床試験プロセスの一環として,研究者が患者・市民の知見を参考にすること)が必要となってきた。 本シンポジウム『これからの臨床試験・臨床研究はどうあるべきか』では,「治験,臨床研究の教育とJSCTR認定制度について」,次のことをお話しさせていただいた。①治験,臨床研究の現状と本学会②JSCTR 認定制度について③今後の治験,臨床研究と教育について -
2 N‒SAS 試験などの臨床研究支援組織の立ち上げの経験
50巻Suppl 1(2022);View Description
Hide Description
2021 年3 月に逝去された日本臨床試験学会前代表理事の大橋靖雄先生と25 年余りに及ぶ臨床研究を支援する組織の立ち上げの経験について報告する。 -
3 UMIN EDC サービスの過去,現在,未来
50巻Suppl 1(2022);View Description
Hide Description
UMIN は,研究,教育,診療,病院経営を含めた,さまざまな医学系情報サービスを運用する公的機関である。特定の目的に特化した公的な医学系情報サービスは世界にいくつかあるが,多目的にわたり,多様な情報サービスを提供する機関は世界でも類例がない。本稿では,UMIN の多くのサービスのなかで,特にEDC サービスの過去の経緯,現在の状況,将来の予定などについて解説を行う。 - Brief Report
-
治験・臨床研究相談窓口への問い合わせ後の患者動向調査に基づく相談窓口機能の評価
50巻Suppl 1(2022);View Description
Hide Description
Background It is recommended to set up consultation services to properly conduct Chiken (clinical trials for marketing approval)and other clinical studies. One of the main tasks of the consultation services is to look for clinical studies(including Chiken)that can be participated at the request of patients. There are no reports investigating whether patients were actually able to participate in the clinical studies presented by the consulting services. Methods Patients who were provided clinical studies information during the period from May 2019 to May 2020 at the clinical studies consultation service of Kyoto University Hospital were followed up for outcomes. Results During the study period, there were a total of 48 requests for information on clinical studies, of which 35 were provided with information on clinical studies in which they could participate. Twelve patients responded to the follow‒up survey, but none of the patients were actually able to participate in the clinical studies for which information was provided. Discussion Searching for clinical studies at the consultation service was based on the patient’s self‒reported medical histories and publicly available information on clinical studies, making it difficult to properly judge the eligibility for participation. In addition, there may have been cases in which participation was withheld due to the risk of experimental treatment. Conclusion The provision of information about clinical studies did not lead to actual participation in clinical studies. The reasons for this were considered to be insufficient accuracy of information, patient anxiety about experimental treatments, and the availability of other options. The significance of providing information on clinical studies needs further investigation in the future.(Jpn Pharmacol Ther 2022;50 suppl 1:s16‒20) -
治験・臨床研究相談窓口への相談案件記録からみたアンメット・メディカル・ニーズの検討
50巻Suppl 1(2022);View Description
Hide Description
Background There have been almost no systematic reports that examined unmet medical needs based on the content of inquiries to the clinical studies consultation service. Method From April 2018 to November 2020, among the inquiries received at the clinical studies consultation service of the Kyoto University Hospital, the number of clinical trial survey requests was totaled and the disease areas with high patient needs were examined. Results During the study period, there were 123 survey requests regarding clinical trials that could be participated. Of these, the largest number of consultations was regarding cancer(60 cases, 49%). Other than that, there were 15 consultations(12%)regarding nervous system diseases. Among the consultations on cancer, the most common was diseases of the digestive system(25 cases, 42%). Among the consultation cases for which information on clinical trials that could be participated was not found, nervous system diseases were the most common. Discussion The high proportion of cancer and nervous system diseases in the disease areas requested to be investigated in clinical trials was similar to the results of investigations by other methods in the past. Our study reaffirmed the high medical needs in these disease areas. Conclusion To clarify the effectiveness of examining unmet medical needs from the survey contents of the consultation service should be followed by further examination.(Jpn Pharmacol Ther 2022;50 suppl 1:s21‒26) - Original Article
-
医療機器治験の申請資料からみた逸脱の分析
50巻Suppl 1(2022);View Description
Hide Description
The objective of the present study was to find the current characteristics of deviations in medical device clinical trials in Japan. For medical devices approved from April 2011 to December 2020, we surveyed the summary of Japanese clinical trials published in the application document summary. We summarized the deviations from the protocol and GCP practice. Forty summary reports mentioned the evaluation results of serious or significant deviations. Eighty‒nine serious or significant deviations occurred in 20 clinical trials against 2621 registered examinees(3.4 cases/100 examinees). Thirty‒three summary reports mentioned the detailed evaluation results of deviations included deviations other than significant or significant deviations. In total, 801 deviations occurred in 30 clinical trials against 2151 registered examinees(37.2 cases/100 examinees). One of the major causes of frequent deviations might be restrictions on the use of familiar drugs or operation procedures. The other might be the setting of allowance in the protocol that did not reflect actual clinical practice. Regarding the data handling of the deviations related to the measurement time, there existed not a small case that the efficacy and safety data sets included those data. In addition, the frequency of deviations was high during the examination on the discontinuation or discharge from the hospital. We showed the current characteristics of deviations in medical device clinical trials in Japan. We believe that these results provide helpful information for preparing a protocol and conducting risk‒based monitoring in medical device clinical trials.(Jpn Pharmacol Ther 2022;50 suppl 1:s27‒36) -
医学研究に二次利用するための医療情報データの特徴・性質調査―大阪大学医学部附属病院 単施設の状況―
50巻Suppl 1(2022);View Description
Hide Description
Background In recent years, there has been an increasing expectation to use real‒world data in the development of drugs and medical devices. However, medical information from electronic medical records is not data collected following research plans. This may lead to problems in which the data is not collected with the quality expected for research, or the data is biased and is different from the target population. Therefore, when using medical information data, it is important to understand the characteristics and properties of the data in advance and to confirm and select the data for the research purpose. Therefore, we conducted a survey to clarify the characteristics and properties of medical information data from Osaka University Hospital(OUH). Method We extracted items frequently used in clinical studies from medical information data of all patients who had their first medical examination at OUH in the past 10 years. Among the data of each item, we examined the distribution and transition over time of patient background and the frequency of missing or abnormal data. Results and Conclusions This study showed that the medical information data of OUH includes some items that were entered according to the status of missing data and the original rules. When using a database, it is necessary to check the error data and examine the cause and handling. Understanding the characteristics and properties of medical information data in advance is expected to facilitate identifying the cause of errors and the selection of databases will be more efficient.(Jpn Pharmacol Ther 2022;50 suppl 1:s37‒50) -
本邦アカデミアにおけるCDISC 標準導入の現状と課題
50巻Suppl 1(2022);View Description
Hide Description
Objective Implementation of the CDISC standards is considered to accelerate clinical research, and the objective of this research is to clarify the current status and challenges of the implementation of the CDISC standards in Japanese academia. Methods The survey period was from April 27 to June 30, 2020, and a questionnaire survey was conducted targeting members of the CDISC expert liaison committee of the Academic Research Organization(ARO)council, TG3(Topic Group 3)of National University Hospital Clinical Research Promotion Initiative(NUH‒CRPI), and Metropolitan Academic Research Consortium(MARC). Results We received valid responses from 41 facilities. Nineteen point five percent of the facilities had CDISC data generation experience, and 34.1% had CDISC standards implementation. On the other hand, more than 70% of the facilities requested to hold a seminar on CDISC standards, OJT, and provide materials and information. Eighty‒five point four percent of facilities answered that“shortage of human resource and economic resources”was an obstacle to the implementation of the CDISC standards. Conclusions The implementation of the CDISC standards has not progressed throughout the academia in Japan, with some facilities being experienced and some not. It is necessary to establish a support system that can support facilities that wish to implement the CDISC standards.(Jpn Pharmacol Ther 2022;50 suppl 1:s51‒61) - Case Report
-
診療科訪問形式による「品質管理講習会」開催の試みについて
50巻Suppl 1(2022);View Description
Hide Description
Background Since the Clinical Trials Act came into effect in 2018 in Japan investigators have had to adhere to strict guidelines in order to ensure the quality and reliability of clinical research. With this in mind, we conducted a series of seminars in numerous clinical departments at the University of Miyazaki Hospital, from July to December 2019 to inform investigators of information pertinent to conducting clinical research. To clarify the efficacy and otherwise further improve the seminar, we collected questionnaire responses from participants. Methods We visited 15 clinical departments at University of Miyazaki Hospital to hold a series of seminars on conducting intervention studies or specific clinical trials. The seminars were divided into two parts, one covering important points for conducting clinical research appropriately and the second concerning quality control for clinical research. Responses to a questionnaire were collected from participants after the seminar. Results We visited 15 clinical departments a total of 22 times. According to the questionnaire, 96% of respondents“understood or largely understood”the seminar, and 98% found it “useful or largely useful”. However, 70% also found it“difficult or rather difficult”. Conclusions These findings suggest that our seminar“by visitation”had a high degree of understanding and usability among participants. However, many participants regarded as difficult, we should continue to think of ways to improve our seminar.(Jpn Pharmacol Ther 2022;50 suppl 1:s62‒66) -
-
-