Proceedings: DIA China 2019
DIA China 2019
Improving Clinical Data Quality and Trial Efficiency in China

Charles Yan
Vice President
Clinical Data Science Center
Hengrui Medicine


he National Medical Products Administration (NMPA) (formerly the CFDA) has clearly focused on quality as its primary objective over the past few years. For example, to protect data integrity and quality, China launched its self-inspection initiative in July 2015. Many new regulatory requirements and guidelines relating to clinical research and data integrity were published thereafter, which resulted in an upsurge in the demand for more efficient models for clinical data collection, monitoring, review, integration, sharing and exchange, and aggregation. Data management and data standards, including identification and application of appropriate information technology, have become a “hot topic” challenge for sponsors as well as regulators.

Key Takeaways

  • Use of information technology to manage clinical trial data and processes, and to support timely decision making, has become a more urgent need in China. Electronic data capture (EDC) tools are widely used in clinical trials, thanks to NMPA’s EDC guideline released in July 2016, while the process standardization and efficiency benefits of Clinical Trial Management Systems (CTMS) and the electronic Trial Master File (eTMF) are receiving increased attention from study sponsors, study sites, and contract research organizations (CROs).
  • A significant majority of subject visit records are generated from routine clinical practice and stored as electronic medical records (EMRs) in individual hospitals or other clinical sites. These EMRs include not only medical patient information such as their medical history, physical examination records, and laboratory reports, but also drug prescription records and medical expenses as well. EMRs are considered to be essential source data for NMPA inspection activities. However, constitutional privacy protections create big challenges for EMR accessibility and usability in China.

Integrated eClinical solutions have demonstrated their usefulness as an efficient tool for improving clinical trial data quality and processing. However, few domestic eClinical solutions are available in China; this is especially applicable to data exchanges across different platforms, systems, and/or applications.

Implementation of global data standards through organizations such as CDISC has also significantly increased clinical trial efficiency in China. Many observers hope that progress in data standards and related subjects will be elevated and advanced when the NMPA issues its eCTD technical documentation, which will include data standards among its requirements, later this year.

In addition, it has become common practice for medical professionals to regularly review clinical trial data and for Independent Data Monitoring Committees (IDMCs) to regularly review safety data. The consistency of EDC and clinical trial randomization and trial supply management (RTSM) systems is also routinely reviewed. These enhanced review practices have also improved the quality of clinical trials and clinical trial data, and will ultimately enhance the quality of healthcare products developed and manufactured in China.

This Data and Data Standards theme also addressed practices and challenges in data standards, including implementation practices, and best practices for IDMCs.