创建于上海的中国新药研发创新领军企业华领医药近日宣布成为临床数据交换标准协会（CDISC）的企业会员。这标志着CDISC拥有了第一家来自中国药企的会员。
CDISC是一个全球性的全学科开放非盈利组织，旨在融合行业最佳实践，为临床研究开发建立一系列统一标准，用于支持临床及临床前数据的电子获取、交换、递交和归档。CDISC更致力于提高医学研究及医学保健相关领域的效率，并为此建立了全球性的非平台依赖的数据标准，以促进各相关信息系统的有机结合。2016年开始，日本和美国的药物监管机构先后启动了递交符合CDISC标准的临床试验数据的强制性要求。中国CFDA也在新出台的行业指导原则中明确鼓励递交符合CDISC标准的临床试验数据，强化对临床试验数据质量和标准化的重视，这对改善和提高中国新药研发的环境有积极而深远的正面影响。
华领医药早在2015年即开始内部研究并推动CDISC标准化的应用，并在其“全球新”抗糖尿病药葡萄糖激酶激活剂HMS5552的2期临床研究中率先采用了该国际标准，极大的保障了临床数据的质量并取得稳健的统计分析结果。秉承对临床试验数据质量的最高标准理念，华领医药坚信CDISC标准能协助申办方公司做好临床数据质量和分析的管理，从而极大的提高数据审核和递交的效率和成功率。作为CDISC的新会员，华领医药将继续与同行群策群力，积极将CDISC标准实践于中国原创新药的研究和开发中。
“这是CDISC在中国及亚太地区一个重要的里程碑。祝贺华领医药成为中国首家药企CDISC会员，欢迎加入CDISC大家庭！” CDISC亚太协调委员会主席（AP3C）张子豹博士说到。“华领医药是一家中国知名的创新型生物科技公司，一直以来致力于按照国际标准开发全球性新药。我们相信CDISC标准可以促进华领医药的临床研究，从数据采集到全球数据提交，包括基于CDISC标准的数据采集、结构标化和统计分析；进而提高数据质量和整个临床试验流程的效率。”张博士补充到，“CDISC期待和欢迎更多中国和亚太地区的领先公司加入CDISC，充分利用CDISC标准和CDISC提供给会员公司的福利（如知识库、在线培训资源和工具）。”
中国CDISC协调委员会副主席彭瑞玲亦为华领医药表达祝贺：“在为华领提供服务的这一年期间，我及医普科诺深刻感受到，华领所有同事都真正切切地将患者安全和健康放在第一要务，华领管理团队和核心技术团队在整个药物研发的思路和流程都致力与国际接轨--在II期试验过程中就已采纳CDISC标准，并积极加入CDISC组织，便是最强有力的证据！作为CDISC C3C（中国CDISC协调委员会）副主席，在亲眼见证华领成为中国第一家CDISC药企会员的激动时刻，衷心祝愿华领在CDISC数据标准的应用实施方面引领中国走向世界！”
Hua Medicine Announces CDISC Membership – A PivotalMilestone to Establish the First CDISC Member from China Pharma
Hua Medicine Inc. (Hua), a leading clinical-stage biotech based in Shanghai (China), announces membership in CDISC. Hua becomes the first CDISC member as a biopharmaceutical company based in China.
CDISC is a global, open, multidisciplinary, non-profit organization that develops data standards to streamline the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. In 2016, both PMDA (Japan) and the US FDA mandated the requirements to submit CDISC compliant data for regulatory reviews. Chinese FDA (CFDA) also encourages the implementation of CDISC standards in new guidelines, demonstrating high value of global standards to control the quality of clinical data. The influence on the current status of clinical trials in China is profoundly positive.
Hua strived to establish CDISC standards internally as early as in 2015, and adopted CDISC standards for the first time in the phase 2 trial of its first-in-class glucokinase activator HMS5552, which yielded high-quality clinical data and robust statistical analysis results. Hua believes that implementing CDISC standards in research studies will benefit the sponsors to improve data quality and thus increase the likelihood of effective and successful data reviews and submissions. As a new CDISC member, Hua will proactively work with its peers to contribute to the implementation of CDISC standards in the discovery and development of novel medications in China.
“It’s a great milestone for CDISC in China and APAC. Congratulations Hua as the first CDISC member in the Chinese biopharma section, and welcome to CDISC family!” Dr. Zibao Zhang, Chair of APAC CDISC Coordinating Committee (AP3C) said. “Hua is a well-known innovative biotech company in China with a dream of developing brand new medical products worldwide at global quality.” “We believe CDISC standards could facilitate Hua’s clinical development from data collection to global data submission through CDISC standard-based data collection, tabulation and analysis, while enhancing the data quality and process efficiency.” Dr. Zhang added “CDISC expects and welcomes more leading companies in China and APAC to join CDISC and leverage the benefits of CDISC standards and membership.”
The Vice President of China CDISC Coordinating Committee (C3C), Ruiling Peng, also expressed congratulations to Hua Medicine: “During the last year when we Improve-Quality served for Hua Medicine, we are deeply moved by: all Hua Medicine colleagues truly fully put patients first, and both of Hua Medicine management team and core technology team conduct their drug Research & Development in line with global standards—especially the data standards. Early implementing CDISC standards into phase II study, and proactively joining CDISC member family are the solidest evidences! As the vice-president of CDISC C3C, I witness the exciting moment when Hua Medicine ranked as the first Chinese biopharmaceutical CDISC member, and here to wish Hua Medicine will lead Chinese industry to implement CDISC into global stage.”