Asymchem Clinical (Clin-nov) recently invited Mr. Sun Haiquan, Senior Director of the Statistical Programming Department, to present at the Chengdu-Chongqing Biostatistics Forum (CBF). His keynote address, titled "The Application of Data Standards in the Execution of Estimating Clinical Research Targets," provided valuable insights into the critical role of biostatistics in supporting clinical research, particularly in the development of innovative drugs and medical devices—a national strategic priority in China.
Biostatistics plays an increasingly vital role in clinical development, guiding key decision-making processes in the pharmaceutical and medical device sectors. Recognizing the importance of this field, academic institutions and industry professionals from Chengdu and Chongqing established the CBF to facilitate dialogue between university professors specializing in biostatistics, statisticians, programmers, data managers, and other experts in the industry.
The inaugural meeting of the CBF was a resounding success, featuring participation from leading organizations including Asymchem Clinical. As a technology-driven Clinical Research Organization (CRO) and the first CDISC member in China under its Statistical Services division, Asymchem Clinical boasts a team of over 160 Biometrics experts who have supported more than 100 innovative drug projects globally, with extensive experience in oncology and dual regulatory submissions between China and the U.S.
Mr. Sun Haiquan's presentation took place during the forum's afternoon session. From 16:11 to 16:35, delving into the practical application of data standards in clinical research and engaging the audience with his expertise in estimating clinical research targets.
One key focus of Mr. Sun's presentation was the implementation of ICH E9(R1) guidelines, adopted by the International Council for Harmonisation (ICH) in 2019. In response, China's National Medical Products Administration (NMPA) has aligned its technical registration standards with international practices, mandating the use of ICH E9(R1) in recent years. This regulatory shift has introduced new challenges in clinical trials, particularly in the adoption and adaptation of evolving data standards.
Drawing on his 14 years of experience in biostatistics and programming, Mr. Sun provided a comprehensive overview of the application of data standards in estimating clinical research targets. His presentation, grounded in real-world case studies, covered critical aspects such as data collection, tabulation, and the analysis of datasets. He offered a detailed exploration of the Adverse Events In Clinical Evaluations (ADICE) data standard, emphasizing its data structure and variable framework. Mr. Sun explained the rationale behind the formation of ADICE and demonstrated how it integrates with other analysis datasets to ensure traceability throughout the entire data analysis process.
The Chengdu-Chongqing Biostatistics Forum offered a platform for thought leaders in biostatistics to share best practices and address the challenges posed by evolving data standards in clinical research. Asymchem Clinical's participation, highlighted by Mr. Sun Haiquan’s insightful presentation, underscores the company's commitment to advancing Biostatistics and supporting development and implementation of innovative drugs and medical devices through robust data analysis standards.
