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A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
[Challenges to International Collaborative Clinical Research and Approval Disparities]
Yukinori Ozaki1, Toshimi Takano
1Dept. of Breast Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research.
Abstract:
The standard treatment and prognosis of breast cancer are improving as because of international collaborative clinical research. Generally, the standard treatment for breast cancer in Japan is not different from that in the US, Europe or other Asian countries, however, some novel agents have not been developed or have been delayed. For example, no institution in Japan has participated in the clinical trials of sacituzumab-govitecan. Institutions in Japan participated in the clinical trial of alpelisib and neratinib, however, the development of these drugs was delayed due to the racial difference and lack of a company in charge. On the other hand, there are international collaborative trials that Japan has participated in or has taken the lead, such as POSITIVE trial, CREATE-X trial, and PATHWAY trial. There are many challenges for Japan to participate in or lead international collaborative trials with Europe, US, or Asia. It is necessary to build a network and infrastructure for international collaborative trials based on the cooperation between the institutions and clinical trial groups in the world.
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