From October 22-24, the 4^th three-day Symposium on Clinical Study Quality hosted by China Quality Association for Pharmaceuticals (CQAP) was successfully concluded in Beijing. Clinical study plays a vital role in the process of innovative drug development. In order to promote the development and rapid improvement of clinical study capabilities in China, this conference focused on the quality and efficiency of clinical study. Seven major presentations made by more than 100 experts attracted a lot of industry experts to communicate and share their opinions together. Elixir Clinical Research participated in this conference as a golden supporting party. Dr. Yuji Feng, Associate General Manager and Head of Real-World Studies of Elixir Clinical Research, was invited and delivered a keynote speech on "Practices and Challenges of Leveraging Digital Platforms to Support Real-World Studies".

With increased policy support, real-world evidence (RWE) has become an important tool to support regulatory decision-making and lifecycle management of drugs and other medical products. The approval of first medical device using real-world evidence-assisted clinical evaluation in China in March 2020 marked the initial implementation of RWE-supported pharmacovigilance review in China.

Production-compliant, accessible, and traceable high-quality real-world data (RWD) is key to generating high-quality real-world evidence. When clinical researches are performed, following major problems are still quite common: contradiction between the large amount of accumulated case data and high-quality output; low quality clinical data, insufficient data comprehensiveness, low data accessibility and difficulty in data sharing; insufficient clinical research capacity and time for front-line physicians, as well as scarce clinical research service teams for huge research demand.

To address such real-world challenges, Dr. Yuji Feng shared a few principles for leveraging digital platforms to support real-world studies:

1.The database should be established based on the hospitals' real clinical all-patient treatment data and be able to capture data in real time.

2.Digital medical tools such as remote monitoring should be used for patient disease management. Patient engagement should be increased. The collection of out-of-hospital data and patient self-reported data should be strengthened. Connection and integration with in-hospital data should be achieved.

3.The acquired data should be cleaned and structured, and all consultation data for the same patient should be connected and integrated to provide a longitudinal track record on an individual patient basis.

4.A common data model (CDM) compatible with different types of data and terminology systems should be established to further build a distributed research network and improve the efficiency of data interoperability and analysis.

5.While completing real-world data governance, we establish a management platform for digital data analysis and utilization to reduce the difficulty of data utilization and clinical research by front-line researchers, and improve data utilization and research output.

-- Yuji Feng

Associate General Manager of Elixir Clinical Research

Head of Real-World Studies

Real-World Studies Services of Elixir Clinical Research

Elixir Clinical Research is committed to building a technology-based RWE platform that provides high-quality real-world research solutions and a full range of research services, covering registration, post-marketing evaluation, health insurance access, clinical research support and information services. First-class professional team, together with "data platform + RWE solutions + data analysis", provides a more scientific and comprehensive overall solutions to uncover more valuable real-world evidence for you.

Elixir Clinical Research Booth

Pharmaceutical innovation has been regarded as a national strategy. The pharmaceutical industry in China is entering the best innovation era. Thank you for your support and attention during the conference! In order to achieve the mission of "Making good drugs accessible", Elixir Clinical Research will continue to collaborate with multiple parties and collect industry wisdom to empower the management and operation of clinical study throughout the life cycle with digital technology, and facilitate the launching of new drugs quickly!