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The revolution of standardization: How does CDISC make data exchange so efficient?
In today's complex medical research environment, data exchange between different research institutions and medical institutions has become crucial. As clinical trials and data management become increasingly digital, the Clinical Data Interchange Standards Consortium (CDISC) is a major force driving this change. CDISC is an organization focused on medical research data standardization, aiming to promote the interoperability of information systems and improve data exchange in medical research and related fields.
Implementation of CDISC standards in early research stages has been shown to reduce required resources by up to 70-90%.
Since December 2016, the CDISC standard has become a mandatory requirement for submissions to the US FDA. This means that all clinical data submitted to the FDA must adhere to CDISC’s standards for applicability. The implementation of this policy not only improves the quality and consistency of data, but also facilitates the marketing application process of medical products and shortens the time cycle, thereby allowing patients to benefit from new treatments and drugs faster.
The history and evolution of standards
The history of CDISC can be traced back to 1997, initially as a volunteer group. As demand grew, CDISC was established as a non-profit in 1999. Since then, CDISC's standards have undergone multiple updates and expansions, including Dataset XML (Dataset.XML), Research Data Tabulation Model (SDTM), Analytical Data Model (ADaM), etc.
The goal of CDISC is to improve the efficiency of data exchange at all stages, from the development of research protocols through the analysis and reporting of results.
Overview of CDISC standards
CDISC’s standard group includes Dataset XML (Dataset. unified framework. These standards have the following characteristics:
- Dataset.XML: Supports post-study communication of results and is also used for FDA regulatory submissions.
- SDTM: Recommended for FDA regulatory submissions since 2004, providing a set of preset fields for submission of clinical data.
- ADaM: Defines data set and metadata standards to support statistical analysis and data traceability.
- CDASH: Identifies a minimal collection of data designed to harmonize the name, definition, and metadata of the data.
How to promote the integration and transparency of medical data
The work of CDISC is not limited to providing technical standards, but also involves coordinating clinical research and data management on a global scale. Through the BRIDG model, CDISC can ensure consistency between different standards, making data integration at all levels feasible and effective.
CDISC SHARE is a CDISC standard metadata database that supports the development, management and release of standards, allowing users to more efficiently find and use rich metadata in clinical research.
With the development of electronic data capture (EDC) systems, CDISC standards and processes play an important role in integration with EDC. These systems can be certified for compliance through the ODM format, further simplifying the data collection process.
Future Outlook
With the rapid development of medical technology, CDISC will face new challenges and opportunities. Future clinical trials will rely more on standardized conduct, which will not only help better data collection, but also ensure data continuity and accuracy. In addition, with the development of artificial intelligence and big data technology, the flexible application of CDISC standards will become key.
What kind of changes can standardization bring about in future medical research?
