A cross‐sectional survey on principal investigators' clinical research knowledge in Japan

Abstract Principal investigators (PIs) play a key role in clinical research, and must thus understand the role of clinical research support staff to conduct successful and appropriate clinical research. This study evaluates clinical research capabilities by examining the clinical research knowledge...

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Main Authors: Miwa Sekine, Koshi Kataoka, Yuji Nishizaki, Kotone Matsuyama, Toshiaki Otsuka, Kensuke Sato, Mayumi Idei, Shoji Sanada
Format: Article
Language:English
Published: Wiley 2023-03-01
Series:Clinical and Translational Science
Online Access:https://doi.org/10.1111/cts.13456
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author Miwa Sekine
Koshi Kataoka
Yuji Nishizaki
Kotone Matsuyama
Toshiaki Otsuka
Kensuke Sato
Mayumi Idei
Shoji Sanada
author_facet Miwa Sekine
Koshi Kataoka
Yuji Nishizaki
Kotone Matsuyama
Toshiaki Otsuka
Kensuke Sato
Mayumi Idei
Shoji Sanada
author_sort Miwa Sekine
collection DOAJ
description Abstract Principal investigators (PIs) play a key role in clinical research, and must thus understand the role of clinical research support staff to conduct successful and appropriate clinical research. This study evaluates clinical research capabilities by examining the clinical research knowledge of PIs and clinical research support staff. The participants of this cross‐sectional study were academic researchers and clinical research support staff from Japanese universities and research institutions. The participants comprised of 54 respondents, among whom 36 were PIs (physicians) and 18 were clinical research support staff. A self‐administered electronic survey was created and evaluated by experts, with 50 knowledge items. Mann–Whitney U tests were used to determine the significance of the differences in knowledge between clinical research support staff and PIs. We compared the correct answer rate of clinical research support staff and PIs for each knowledge category and observed that the clinical research support staff scored significantly higher than the PIs in all aspects of clinical research knowledge sections, including total score. Our findings showed that PIs did not have the same amount of clinical research knowledge as the clinical research support staff. Clinical research knowledge is essential for investigators, especially PIs, to protect patients and promote medical breakthroughs. Thus, more accessible clinical research education and mandatory knowledge testing will allow PIs to lead successful clinical research and further the level of medical research in Japan.
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spelling doaj.art-538b9b072a7046e9afca4b8ca42ff2ac2023-03-15T04:35:39ZengWileyClinical and Translational Science1752-80541752-80622023-03-0116345946610.1111/cts.13456A cross‐sectional survey on principal investigators' clinical research knowledge in JapanMiwa Sekine0Koshi Kataoka1Yuji Nishizaki2Kotone Matsuyama3Toshiaki Otsuka4Kensuke Sato5Mayumi Idei6Shoji Sanada7Division of Medical Education Juntendo University Faculty of Medicine Tokyo JapanDivision of Medical Education Juntendo University Faculty of Medicine Tokyo JapanDivision of Medical Education Juntendo University Faculty of Medicine Tokyo JapanCenter for Strategic Research Initiative Nippon Medical School Foundation Tokyo JapanDepartment of Hygiene and Public Health Nippon Medical School Tokyo JapanClinical Research and Trial Center Juntendo University Hospital Tokyo JapanMedical Technology Innovation Center Juntendo University Faculty of Medicine Tokyo JapanClinical and Translational Research Center Kobe University Hospital Hyogo JapanAbstract Principal investigators (PIs) play a key role in clinical research, and must thus understand the role of clinical research support staff to conduct successful and appropriate clinical research. This study evaluates clinical research capabilities by examining the clinical research knowledge of PIs and clinical research support staff. The participants of this cross‐sectional study were academic researchers and clinical research support staff from Japanese universities and research institutions. The participants comprised of 54 respondents, among whom 36 were PIs (physicians) and 18 were clinical research support staff. A self‐administered electronic survey was created and evaluated by experts, with 50 knowledge items. Mann–Whitney U tests were used to determine the significance of the differences in knowledge between clinical research support staff and PIs. We compared the correct answer rate of clinical research support staff and PIs for each knowledge category and observed that the clinical research support staff scored significantly higher than the PIs in all aspects of clinical research knowledge sections, including total score. Our findings showed that PIs did not have the same amount of clinical research knowledge as the clinical research support staff. Clinical research knowledge is essential for investigators, especially PIs, to protect patients and promote medical breakthroughs. Thus, more accessible clinical research education and mandatory knowledge testing will allow PIs to lead successful clinical research and further the level of medical research in Japan.https://doi.org/10.1111/cts.13456
spellingShingle Miwa Sekine
Koshi Kataoka
Yuji Nishizaki
Kotone Matsuyama
Toshiaki Otsuka
Kensuke Sato
Mayumi Idei
Shoji Sanada
A cross‐sectional survey on principal investigators' clinical research knowledge in Japan
Clinical and Translational Science
title A cross‐sectional survey on principal investigators' clinical research knowledge in Japan
title_full A cross‐sectional survey on principal investigators' clinical research knowledge in Japan
title_fullStr A cross‐sectional survey on principal investigators' clinical research knowledge in Japan
title_full_unstemmed A cross‐sectional survey on principal investigators' clinical research knowledge in Japan
title_short A cross‐sectional survey on principal investigators' clinical research knowledge in Japan
title_sort cross sectional survey on principal investigators clinical research knowledge in japan
url https://doi.org/10.1111/cts.13456
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