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COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH

BACKGROUND: Clinical physicians have difficulties in conducting investigator-initiated-trials because of increasing clinical duties in Japan. Therefore, physician support can be one of the important factors for quality control and quality assurance. In Kyoto University Hospital, clinical research pr...

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Autores principales: Furukawa, Keiko, Arakawa, Yoshiki, Mineharu, Yohei, Tanji, Masahiro, Takaori, Akifumi, Miyamoto, Susumu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7213125/
http://dx.doi.org/10.1093/noajnl/vdz039.191
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author Furukawa, Keiko
Arakawa, Yoshiki
Mineharu, Yohei
Tanji, Masahiro
Takaori, Akifumi
Miyamoto, Susumu
author_facet Furukawa, Keiko
Arakawa, Yoshiki
Mineharu, Yohei
Tanji, Masahiro
Takaori, Akifumi
Miyamoto, Susumu
author_sort Furukawa, Keiko
collection PubMed
description BACKGROUND: Clinical physicians have difficulties in conducting investigator-initiated-trials because of increasing clinical duties in Japan. Therefore, physician support can be one of the important factors for quality control and quality assurance. In Kyoto University Hospital, clinical research professional’s support for physician had started at November 2012. In this study, we evaluate effect of physician supports on quality control and quality assurance in clinical brain tumor research. METHODS: Our department of Neurosurgery has been a member of Brain Tumor Study Group in Japan Clinical Oncology Group (JCOG) since 2007. The number of registered patients, the status of periodic monitoring, the occurrence of inquiries per case, and details of physicians’ support (items, frequency, methods, etc.) in each clinical trial were investigated. The factors affecting the audit results conducted by JCOG Audit Committee on January 2013 and February 2019 are examined. RESULTS: There are seven trials have been ongoing on or started since November 2012. There are fifty patients registered in the clinical studies until July 2019. Periodic monitoring has been carried out in 214 patients of cumulative total number since 2012. Physicians’ support mainly involved the preparation of ethical review documents, CRF documentation, responses to data queries, preparation of SAE reports, study schedule check and monitoring of observation items. The audit results of site visit were acceptable, total evaluation score 68.80 on January 2013 and excellent, total evaluation score 99.9 on February 2019. CONCLUSION: Clinical Trials Act has been implemented, and further improvement in the quality of clinical trials has been demanded. As the results of this study, we clarified the necessity for physician support and the contribution to quality improvement.
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spelling pubmed-72131252020-07-07 COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH Furukawa, Keiko Arakawa, Yoshiki Mineharu, Yohei Tanji, Masahiro Takaori, Akifumi Miyamoto, Susumu Neurooncol Adv Abstracts BACKGROUND: Clinical physicians have difficulties in conducting investigator-initiated-trials because of increasing clinical duties in Japan. Therefore, physician support can be one of the important factors for quality control and quality assurance. In Kyoto University Hospital, clinical research professional’s support for physician had started at November 2012. In this study, we evaluate effect of physician supports on quality control and quality assurance in clinical brain tumor research. METHODS: Our department of Neurosurgery has been a member of Brain Tumor Study Group in Japan Clinical Oncology Group (JCOG) since 2007. The number of registered patients, the status of periodic monitoring, the occurrence of inquiries per case, and details of physicians’ support (items, frequency, methods, etc.) in each clinical trial were investigated. The factors affecting the audit results conducted by JCOG Audit Committee on January 2013 and February 2019 are examined. RESULTS: There are seven trials have been ongoing on or started since November 2012. There are fifty patients registered in the clinical studies until July 2019. Periodic monitoring has been carried out in 214 patients of cumulative total number since 2012. Physicians’ support mainly involved the preparation of ethical review documents, CRF documentation, responses to data queries, preparation of SAE reports, study schedule check and monitoring of observation items. The audit results of site visit were acceptable, total evaluation score 68.80 on January 2013 and excellent, total evaluation score 99.9 on February 2019. CONCLUSION: Clinical Trials Act has been implemented, and further improvement in the quality of clinical trials has been demanded. As the results of this study, we clarified the necessity for physician support and the contribution to quality improvement. Oxford University Press 2019-12-16 /pmc/articles/PMC7213125/ http://dx.doi.org/10.1093/noajnl/vdz039.191 Text en © The Author(s) 2019. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Abstracts
Furukawa, Keiko
Arakawa, Yoshiki
Mineharu, Yohei
Tanji, Masahiro
Takaori, Akifumi
Miyamoto, Susumu
COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH
title COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH
title_full COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH
title_fullStr COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH
title_full_unstemmed COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH
title_short COT-11 EFFECT OF PHYSICIAN SUPPORTS ON QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL BRAIN TUMOR RESEARCH
title_sort cot-11 effect of physician supports on quality control and quality assurance in clinical brain tumor research
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7213125/
http://dx.doi.org/10.1093/noajnl/vdz039.191
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