From June 17-19, Clinical Data Management 2021 China Conference was successfully held and concluded in Shanghai. The 3-day conference focused on driving CDM with digital transformation, covering 8 hot topics. More than 30 speakers and experts from the industry shared their views on risk-based data audit, exploration of intelligent digital technology in data management, positioning and growth path of data managers in the era of digital intelligence, clinical trial data submission under new regulations, regulatory requirements and verification items for international submission of new drugs, and challenges, opportunities brought by technological reforms and changes in regulatory requirements and response strategies.

Application and practice of standard data specifications in real-world studies- Elixir Clinical Research INSIGHTS

In recent years, "real-world studies" has received increasing attentions from home and abroad, and real-world clinical studies have been developing rapidly. Since the first appearance of real-world studies in the official document in July 2018 - Notice on Soliciting Proposals for Evaluation of Specific Medical Products in China in the 289 Basic Drug List, more and more "first" appearances have shown up ever since the policy affirmation at the national regulatory level to the publication of guidelines by authoritative academic organizations, making real-world studies in China start to get on the right track. In 2020, the National Medical Products Administration (NMPA) released the first Guidelines for Real-World Evidence to Support Drug Development and Review (Interim), thereby China's drug development and evaluation enters into a new phase.

As medicine integrates with big data and artificial intelligence, a lot of real-world studies evidence can be applied to research and practice related to new drug development and review, which continues to drive regulation, decision-making and changes in the global pharmaceutical industry.

Real-world data is derived from a variety of data related to patient health status and/or treatment and care collected in daily healthcare services. Real-world data must be obtained through scientific study design, rigorous organizational implementation and reasonable statistical analysis. Data quality control in real-world studies is key to ensuring its authenticity, accuracy, and reliability. Only real-world data that satisfy applicability can generate real-world evidence. To ensure data quality, data management and services are particularly important. Data management has become a key part of clinical study and is an important data quality guarantee.

On this basis, Dr. Yuji Feng makes the following points:

1. With the increased policy support and improved information technology in healthcare, China has rapidly growing demands for real-world data and evidence. Primary sources of real-world data for clinical study come from diagnosis and treatment information in hospitals. The prerequisites of real-world data development and utilization are based on effective integration of clinical data from different sources within hospitals and patient-centered clinical database. In addition, out-of-hospital data are collected through intelligent follow-up systems and electronic wearable devices to form a closed loop of patient clinical data.

2. At present, there is still a gap between medical data quality and the needs of real-world studies in China, especially more innovative solutions are required in the clinical treatment records standardization, medical data standardization, terminology application, and medical texts processing, and there is also a particular need to establish a terminology system for symptoms, drugs, laboratory tests, etc.

3. The principles of authenticity, reliability, and traceability must be followed in the collection of real-world data. For different sources of data, a common data model can be used to standardize heterogeneous data; for registration items, international common standards such as CDISC should be used.

Real-world studies create a new pathway for drug marketing and evaluation, which will greatly promote more innovative drugs to enter the Chinese market and bring more optimized treatment options for patients, and will play an increasing role in clinical study.

Innovative data management solutions attract a lot of attention BOOTH

As a technology-enabled full service CRO, Elixir Clinical Research uses advanced digital technology to drive the management and operation of entire process of clinical study projects, providing partners with more accurate and higher quality data, giving new impetus to the development of clinical study, and making evidence-based choices. The conference attracted many attendees. Senior experts in data management from Elixir Family interacted with new and existing clients, and proposed targeted and innovative solutions to the difficulties encountered by them in clinical data projects.

Look forward to meeting you again!