Clinical trial coordination under the evaluation system of investigational medical care in Japan: Operational challenges in multi-center cancer clinical trials

Eriko Aotani, Tomomi Hata, Atsuko Kawakami, Sae Tsuboi, Nami Numagami, Mayumi Ushitani, Kaoru Miyata, Miwa Nonaka, Masahiro Takeuchi, Toru Takebayashi, Keiichi Fujiwara

Research output: Contribution to journalArticlepeer-review

Abstract

The Evaluation System of Investigational Medical Care (ESIMeC) is a new clinical trial system that Ministry of Health, Labour and Welfare authorizes the coverage of medical expenses by Japanese health insurance system for the patients participating in the approved clinical trials with high quality control mechanism. This system became effective in 2008. The Kitasato University Clinical Trials Coordinating Center has supported two randomized, phase III trials being conducted under ESIMeC since 2009. One trial is to evaluate the efficacy and safety of intraperitoneal (IP) chemotherapy of Carboplatin for ovarian cancer patients ; another trial is to evaluate the efficacy and safety of new anticancer agent Bevacizumab for recurrent ovarian cancer patients. Carboplatin is approved for ovarian cancer by intravenous administration, but not for IP administration. Bevacizumab is not approved for ovarian cancer. However, the indication-directed trial has been completed for the first line chemotherapy for ovarian cancer, but not for the recurrent setting. In this article, we discuss the issues that need to be improved in the future, as well as the importance of the clinical trial coordinating center, so that ESIMeC will work better to accelerate investigator-initiated clinical trials evaluating new agents/medical techniques with no indication approval in Japan. Critical issues in cancer clinical trial coordination under ESIMeC include being familiar with the system itself, development of the clinical trial team, support of the application process for ESIMeC, establishment of serious adverse event reporting procedures, management of the study agents, and cost-effective study monitoring.

Original languageEnglish
Pages (from-to)S67-S79
JournalJapanese Pharmacology and Therapeutics
Volume40
Issue numberSUPPL. 1
Publication statusPublished - 2012 Mar 25
Externally publishedYes

Keywords

  • Clinical Research Management
  • Clinical Trail
  • Evaluation System of Investigational Medical Care (ESIMeC)

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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