Anzai Takayuki, Matsuyama Takaaki, Wasko Michael, Hatakeyama Hirofumi, Horikawa Shin-Ichi, Anzai Reo, Iwata Hijiri, Imai Norio, Mizuhashi Fukutaro, Tsuboi Masaru, Okuzono Takeshi, Takagi Hisayoshi, Cho Hyeon, Rong Bryan Tan Siang, Masaki Fumio, Nakae Dai
Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-0064, Japan.
PDS Life Science, 100 Valley Road, Suite 204, Mt. Arlington, NJ 07856, U.S.A.
J Toxicol Pathol. 2019 Apr;32(2):119-126. doi: 10.1293/tox.2018-0066. Epub 2019 Mar 2.
The Standard for Exchange of Nonclinical Data (SEND), adopted by the US Food and Drug Administration (FDA), is a set of regulations for digitalization and standardization of nonclinical study data; thus, related organizations have begun implementing processes in support of SEND. The Global Editorial and Steering Committee (GESC), which provides oversight of the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND), has prepared the SEND Controlled Terminology (CT) for toxicologic pathology. SEND provides electronic data standards created by the Clinical Data Interchange Standards Consortium (CDISC), and CDISC also collaborates in the implementation of SEND. Furthermore, the Pharmaceutical Users Software Exchange (PhUSE), which includes members of the US FDA, has conducted various activities to promote realistic and effective methods to implement SEND. As we reported in 2015, there is a significant variation in the efficiency and quality of SEND data implementation across pharmaceutical companies and contractors (CROs) globally. To address this problem, the Global SEND Alliance (G-SEND) was established in August 2018 to facilitate the coordination and standardization of SEND datasets across CROs in Asia. This paper reports the first method for organizationally and jointly creating consistent SEND datasets between CROs using G-SEND.
美国食品药品监督管理局（FDA）采用的非临床数据交换标准（SEND）是一套针对非临床研究数据数字化和标准化的法规；因此，相关组织已开始实施支持SEND的流程。负责监督国际术语和诊断标准协调（INHAND）的全球编辑和指导委员会（GESC）已经制定了毒理学病理学的SEND受控术语（CT）。SEND提供了由临床数据交换标准协会（CDISC）创建的电子数据标准，CDISC也在SEND的实施方面开展合作。此外，包括美国FDA成员在内的制药用户软件交换组织（PhUSE）开展了各种活动，以推广实施SEND的切实有效方法。正如我们在2015年所报道的，全球制药公司和合同研究组织（CRO）在SEND数据实施的效率和质量方面存在显著差异。为解决这一问题，全球SEND联盟（G-SEND）于2018年8月成立，以促进亚洲各CRO之间SEND数据集的协调和标准化。本文报告了使用G-SEND在各CRO之间组织并联合创建一致的SEND数据集的第一种方法。
