{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T04:45:35Z","timestamp":1773290735821,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,12,26]],"date-time":"2020-12-26T00:00:00Z","timestamp":1608940800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2021,3]]},"abstract":"The purpose of this study was to conduct a factual survey to evaluate the type of clinical research support offered by service providers (supporters) in Japanese academic research organizations (AROs). From September to October 2018, we conducted an online questionnaire targeting researchers and supporters of AROs, including individuals supporting research and development (R&D) planning, as well as those involved in study management, biostatistics, coordination, data management, monitoring, and auditing. The number of responses was tabulated for each survey item. For items with written descriptions, we compiled summaries using the inductive regression method of qualitative research. Responses were obtained from 124 researchers, 258 supporters, and 40 AROs. None of the institutions responded that they had a performance index for all types of service providers, whereas 47% of institutions had an index for 1\u20133 types of service providers, and 40% of institutions had no index. Many institutions responded that they had a performance index for coordinators and data management, but few responded that there was a performance index for individuals engaged in R&D and study management. Furthermore, for all evaluations of AROs and researchers, the level of supporter satisfaction was low at only 20%. There was a discrepancy between the levels of researcher expectations and the actual contribution of R&D in the process of research planning. Our survey revealed that there is currently no performance index for services supporting clinical research. In future studies, we need to examine a performance index that accurately reflects the researcher attitudes revealed in this study.<\/jats:p>","DOI":"10.1111\/cts.12942","type":"journal-article","created":{"date-parts":[[2020,12,5]],"date-time":"2020-12-05T17:41:07Z","timestamp":1607190067000},"page":"745-755","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Performance Index for Types of Clinical Research Support Service Providers for Academic Research Organizations in Japan: A Cross\u2010Sectional Survey"],"prefix":"10.1111","volume":"14","author":[{"given":"Keiko","family":"Ueda","sequence":"first","affiliation":[{"name":"Regulatory Strategy Division Clinical Research Support Center University of Tokyo Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoto","family":"Uemura","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Faculty of Medicine Oita University Oita Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kotone","family":"Matsuyama","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management Nippon Medical School Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Nishizaki","sequence":"additional","affiliation":[{"name":"Medical Technology Innovation Center Juntendo University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nanae","family":"Tanemura","sequence":"additional","affiliation":[{"name":"Division of Drug Development & Regulatory Science Faculty of Pharmacy Keio University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kento","family":"Asano","sequence":"additional","affiliation":[{"name":"Department of Medical Innovation Osaka University Hospital Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuki","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Clinical Research, Innovation, and Education Center Tohoku University Hospital Sendai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naotake","family":"Yanagisawa","sequence":"additional","affiliation":[{"name":"Medical Technology Innovation Center Juntendo University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiaki","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Hygiene and Public Health Nippon Medical School Tokyo Japan"},{"name":"Center for Clinical Research Nippon Medical School Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinji","family":"Yasuno","sequence":"additional","affiliation":[{"name":"Clinical Research Support Center The Jikei University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rieko","family":"Ueda","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Juntendo University Graduate School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yumiko","family":"Seo","sequence":"additional","affiliation":[{"name":"Medical Technology Innovation Center Juntendo University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hironori","family":"Nakagami","sequence":"additional","affiliation":[{"name":"Department of Health Development and Medicine Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shoji","family":"Sanada","sequence":"additional","affiliation":[{"name":"Department of Medical Innovation Osaka University Hospital Osaka Japan"},{"name":"Center for Clinical Research and Innovation Osaka City University Hospital Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,12,26]]},"reference":[{"key":"e_1_2_11_1_1","unstructured":"Healthcare and medical strategy (Cabinet decision July 22 2014) and Plan for the Promotion of Medical Research and Development (Headquarters for Healthcare Policy decision July 22 2014). 5-year Clinical Trial Activation plan 2012[in Japanese] (2014). Accessed May 30 2020."},{"key":"e_1_2_11_2_1","unstructured":"Clinical Trials Act (Act No. 16 of 2017) (2017). Accessed May 30 2020."},{"key":"e_1_2_11_3_1","unstructured":"Japan Medical Association Center for Clinical Trials.Investigator-initiated trials (2019). Accessed May 10 2020."},{"key":"e_1_2_11_4_1","unstructured":"Research project results report (Japan Agency for Medical Research and Development) [in Japanese]. (2018). Accessed May 30 2020."},{"key":"e_1_2_11_5_1","unstructured":"Interim evaluation results of research and development involving life sciences. Council for Science and Technology [in Japanese]. (2019). Accessed May 30 2020."},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2015.06.006"},{"key":"e_1_2_11_7_1","first-page":"391","article-title":"Clinical trials in academia: an international comparison of academic research organization (ARO) [in Japanese]","volume":"32","author":"Kumagai Y.","year":"2015","journal-title":"Neurolog. Ther."},{"key":"e_1_2_11_8_1","unstructured":"Meeting of the National University Hospital Clinical Research Promotion Initiative [in Japanese]. (2017). Accessed May 30 2020."},{"key":"e_1_2_11_9_1","unstructured":"Department for Clinical Research and Trials Division 8th meeting records (2019). Accessed May 10 2020."},{"key":"e_1_2_11_10_1","unstructured":"Department for Clinical Research and Trials Division 16th meeting records (2019). Accessed May 10 2020."},{"key":"e_1_2_11_11_1","first-page":"s59","article-title":"A survey of researchers regarding the Clinical Trials Act","volume":"47","author":"Kunito H.","year":"2019","journal-title":"Japan Pharmacol. Ther."},{"key":"e_1_2_11_12_1","unstructured":"Department of Clinical Research and Trials Division 9th meeting records (2019). Accessed May 10 2020."},{"key":"e_1_2_11_13_1","unstructured":"Ministry of Health Labour and Welfare.2018 publication of the report on operations involving clinical research core hospitals (2018). Accessed May 10 2020."},{"key":"e_1_2_11_14_1","first-page":"47","article-title":"A survey of the state of CRC accredited by the Japanese Society of Clinical Pharmacology and Therapeutics: 2nd report 2018\u2015the state of individuals with accredited CRC qualifications, and contribution of the accredited CRC system [in Japanese]","volume":"50","author":"Haseyama T.","year":"2019","journal-title":"Clin. Pharmacol."},{"key":"e_1_2_11_15_1","unstructured":"Compilation of opinions from core clinical research hospitals (council of each core clinical research hospital) [in Japanese] Accessed May 30 2020."},{"key":"e_1_2_11_16_1","unstructured":"REDCap web page: Research Electronic Data Capture (REDCap)[internet] Accessed February 16 2020."},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2648.2007.04569.x"},{"key":"e_1_2_11_18_1","unstructured":"ICH Harmonized Tripartite Guideline General Consideration for Clinical Trials (ICHE8). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (1997). Accessed May 10 2020."},{"key":"e_1_2_11_19_1","unstructured":"Recommendations for the conduct reporting editing and publication of scholarly work in medical journals. International Committees of Medical Journal Editors (2019). Accessed May 30 2020."},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2010-09-308858"},{"key":"e_1_2_11_21_1","first-page":"221","article-title":"Development of a scale that evaluates the level of expertise of clinical research coordinators [in Japanese]","volume":"50","author":"Kohara I.","year":"2019","journal-title":"J. Clin. Pharmacol. Therap."},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2019.01228"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.12942","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.12942","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.12942","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T22:24:47Z","timestamp":1693607087000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.12942"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,26]]},"references-count":22,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1111\/cts.12942"],"URL":"https:\/\/doi.org\/10.1111\/cts.12942","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,26]]},"assertion":[{"value":"2020-07-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-11","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-26","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}