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Clinical trials in healthy volunteers allow intensive safety monitoring and intensive pharmacokinetic sampling, enabling the acquisition of high\u2010quality, broad\u2010range pharmacokinetic and safety data within a shorter timeframe and at lower cost. Leveraging these advantages by utilizing healthy volunteer trials in place of patient trials may contribute to more rapid and efficient implementation of anticancer drug development and is expected to help eliminate the \u201cdrug lag\u201d and \u201cdrug loss\u201d that have been concerns in Japan's research and development process in recent years. In this study, we investigated the clinical data packages of newly approved anticancer agents in Japan from April 2014 to March 2024 and evaluated trends in cases in which data from Japanese healthy volunteers were obtained. We then summarized key considerations for anticancer drug development in Japan regarding whether data from Japanese healthy volunteers should be obtained.<\/jats:p>","DOI":"10.1111\/cts.70626","type":"journal-article","created":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T03:40:37Z","timestamp":1781581237000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Utilization of Healthy Volunteers in Oncology Drug Development in Japan: A 10\u2010Year Analysis of Approved Anticancer Agents (2014\u20132024)"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-9987-9682","authenticated-orcid":false,"given":"Kana","family":"Morihisa","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Oita University Faculty of Medicine  Yufu City Oita Prefecture Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Yoshitsugu","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Oita University Faculty of Medicine  Yufu City Oita Prefecture Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5717-8251","authenticated-orcid":false,"given":"Hirokazu","family":"Wakuda","sequence":"additional","affiliation":[{"name":"General Clinical Research Center Oita University Hospital  Yufu City Oita Prefecture Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3722-8979","authenticated-orcid":false,"given":"Naoto","family":"Uemura","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Oita University Faculty of Medicine  Yufu City Oita Prefecture Japan"},{"name":"General Clinical Research Center Oita University Hospital  Yufu City Oita Prefecture Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,15]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2012.157"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12703"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.4103\/0253\u20107613.99350"},{"key":"e_1_2_10_5_1","unstructured":"International Conference on Harmonization (ICH) \u201cThe Nonclinical Evaluation Of The Potential For Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals \u201d(2005) https:\/\/database.ich.org\/sites\/default\/files\/S7B_Guideline.pdf."},{"key":"e_1_2_10_6_1","unstructured":"International Conference on Harmonization (ICH) \u201cNonclinical Evaluation For Anticancer Pharmaceuticals \u201d(2009) https:\/\/database.ich.org\/sites\/default\/files\/S9_Guideline.pdf."},{"key":"e_1_2_10_7_1","unstructured":"International Conference on Harmonisation (ICH) \u201cM3(R2) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals \u201d(2009) https:\/\/database.ich.org\/sites\/default\/files\/M3_R2__Guideline.pdf."},{"key":"e_1_2_10_8_1","unstructured":"MHLW Press Release:The results of the 2024 Health and Labour Sciences Special Research Project \u201cSurvey on the actual condition of drug loss and construction of means to solve it\u201d.https:\/\/www.mhlw.go.jp\/content\/10808000\/001462594.pdf."},{"key":"e_1_2_10_9_1","unstructured":"PMDA \u201cGuidelines for Clinical Evaluation of Anticancer Drugs \u201d(2021) https:\/\/www.pmda.go.jp\/files\/000243746.pdf."},{"key":"e_1_2_10_10_1","unstructured":"PMDA \u201cList Of Approved New Drugs \u201d(2026) https:\/\/www.pmda.go.jp\/review\u2010services\/drug\u2010reviews\/review\u2010information\/p\u2010drugs\/0010.html."},{"key":"e_1_2_10_11_1","unstructured":"MHLW \u201cHandling of Sakigake Designation \u201d(2023) https:\/\/www.mhlw.go.jp\/content\/001191257.pdf."},{"key":"e_1_2_10_12_1","unstructured":"MHLW \u201cImplementation of Conditional Accelerated Approval System For Drugs \u201d(2017) https:\/\/www.pmda.go.jp\/files\/000220723.pdf."},{"key":"e_1_2_10_13_1","unstructured":"MHLW \u201cHandling of Priority Review \u201d(2024) https:\/\/www.pmda.go.jp\/files\/000268593.pdf."},{"key":"e_1_2_10_14_1","unstructured":"MHLW \u201cProcedures for Designation of Orphan Drug \u201d(2024) https:\/\/www.mhlw.go.jp\/content\/11120000\/001285832.pdf."},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.26258"},{"key":"e_1_2_10_16_1","unstructured":"PMDA \u201cDrug Information Search. 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