2017年9月21日和22日, CDISC(临床数据交换标准协会)中国交流会议在北京举行, 方恩医药生物统计学团队出席此次会议并发表讲话。
今年会议的主题是“通过标准化赋予创新”, 会议总结了当今中国制药行业现状及其法规政策。随着中国加入ICH并提出相关流程和标准, 全球医药产品开发和监管审查更加高效的开展, 大量机会得以涌现, 因此CDISC标准化成为一个重要的热点问题。
在本届会议中, 方恩医药生物统计学团队领导分享了我们在这一领域的经验。全球生物统计学总裁刘铁浦博士发表了关于CDISC标准的历史沿革及其监管指南的主题演讲; 统计编程副总监王超分享了国内实验中define.xml的实施经验。大家对于在NDA/BLA递交中如何执行CDISC标准提出了各自的见解。
CDISC(临床数据交换标准协会)作为一个全球性的非营利组织, 致力于开发数据标准以简化临床研究, 并促进企业与医疗保健领域的对接。自从美国FDA计划并随后要求提交数据以便进行注册审批, 规范数据标准就成了申办方主要关注的焦点。最近中国CFDA也建议提交标准化数据来进行产品审核。因此, CDISC标准将一定会在加快审查时间和提高质量上起着重要作用。
实施CDISC标准主要的益处包括:
•提高效率
•增强创新能力
•促进数据共享
•增加可预测性
•使数据具有完整的可追溯性
•提高数据质量
•降低成本
•简化流程
方恩医药一直是采用CDISC标准的先驱。从CDSIC建立初始, 我们就是CDISC的金牌会员;我们的高级领导团队密切参与SDTM实施指南的初稿编写和项目预实验测试; 这些年来，我们同时也为全球客户提供了多次相关培训。方恩医药已经积累了深层次的知识体系和丰富的实际操作经验, 随着中国开始在其电子注册申报和审查过程中实施CDISC标准, 方恩医药无疑将在未来几年做出重要贡献。
FMD Biometrics team was excited to participate in the 2017 CDISC China Interchange conference held in Beijing on September 21 and 22.
The theme of this year’s meeting is “Empowering Innovation through Standardization” that sums up very well what’s going on in China in the pharmaceutical industry and regulatory policies. As China joins ICH and brings up processes and standards to coordinate efficient global pharmaceutical product development and regulatory review, many opportunities come up, thus CDISC standardization becomes a critical and timely hot topic.
During the conference, FMD’s biometrics leaders shared our experiences in this subject area. Dr. Tiepu Liu, President of Global Biometrics, presented history and practice of regulatory guidance in adopting CDISC standards. Chao Wang, Associate Director of Statistical Programming, shared experience in implementing Define.XML in China studies. The speakers shared their insights in implementing CDISC in NDA/BLA submissions.
CDISC, Clinical Data Interchange Standards Consortium, as a global, nonprofit organization, develops data standards to streamline clinical research and enable connections to healthcare. Ever since the US FDA planned and later requires data submission for regulatory review and approval, standardizing data format for submission has become a major focal point for sponsors. Recently China FDA has recommended data submission for product reviews and CDISC standards will play a major role in submission format to expedite review time and improve quality.
Major benefits to implement CDISC standards include:
· Fostered efficiency
· Enhanced innovation
· Facilitated data sharing
· Increased predictability
· Complete traceability
· Improved data quality
· Reduced costs
· Streamlined processes
FMD has been a pioneer in adopting CDISC standard in data and analysis and delivery. We have been a gold member of CDISC since the very beginning of CDISC initiative. Our senior leadership team was intimately involved in the first draft of SDTM Implementation Guide and pilot project testing. Over the years, we have provided many training sessions to our global clients. FMD has established in-depth knowledge and hands-on experiences that will undoubtedly make important contributions in the coming years as China starts implementing CDISC standards in its electronic regulatory submissions and reviews.
关于方恩医药
方恩（天津）医药发展有限公司于2007年注册，注册资金为150万美元，是国内目前唯一一个能够提供全方位与国际标准接轨的临床开发服务CRO公司。方恩在天津、北京、上海、南京、广州、成都、沈阳、香港、台湾、美国宾州及亚美尼亚、日本和韩国建立了分支结构。方恩现有员工1400多位，中国大陆的临床运营团队分布在全国36个城市，目前还在不断的发展壮大中，致力于为国内外生物制药或医疗器械客户提供高质量低成本的全方位的临床研究服务。
方恩自成立以来，参与并承担了“十一、五”及“十二、五”重大新药创制项目，通过了国内外大中型制药企业的数十次稽查，为许多国内外领先的医药企业及全球一些非盈利机构和一些新兴的生物医药公司提供临床研究服务。至今为止，方恩已支持提交国内外15个新药证书并有11个已经批准；承接了200多项临床试验项目包括多个治疗领域下的入组10000例的上市后研究；与亚洲300多家临床试验机构保持着良好的合作关系；目前已经为分布于中国大陆、香港、台湾和韩国的各阶段临床试验入组了近60000例受试者。
