Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs

• Main Authors: Tomomi Hata (Author), Kenichi Nakamura (Author), Kan Yonemori (Author), Emi Noguchi (Author), Makiko Watanabe (Author), Joohyuk Sohn (Author), Yen‐Shen Lu (Author), Yoon‐Sim Yap (Author), Kenji Tamura (Author), Yasuhiro Fujiwara (Author)
• Format: Book
• Published: Wiley, 2021-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract There are many differences between Asian regions in terms of the regulatory requirements and operational procedures in conducting international academic clinical trials for the approval of new drugs. The National Cancer Center Hospital in Japan has launched an international investigator‐ini...