How CDISC SDTM Improves Cost & Quality in ISS/ISE in 2024

When investigating the efficacy and safety of a new drug/device it is sometimes necessary to combine the research from multiple clinical trials for your analysis. In such cases, it is important to consider the cost and quality of producing integrated summaries and how CDISC SDTM (Clinical Data Interchange Standards Consortium Study Data Tabulation Model) can aid in reducing costs and improving quality for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) submissions.

Cost-Efficiency Through SDTM Implementation

The first efficiency that CDISC SDTM can bring to an ISS/ISE is the reduction of costs. This can be achieved by following best practices with your study data analysis such as:

• Supply clean and complete data.
• Code all studies to the same dictionaries and same version.
• Prepare submission-ready documents throughout the project lifecycle, applying consistent style and formatting.
• Reduce the number of review cycles and agree the key messages upfront.

In addition to these typical best practices, more advanced methods that use the latest programming techniques and automations will further help you to reduce costs in the following areas:

Standardization and Uniform Structure

Leveraging a uniform structure across clinical trials by using CDASH standards is a vital part of the SDTM framework. This uniformity not only simplifies the process of data integration but also significantly reduces the time required for data alignment and aggregation across multiple studies.

Macros and Standard Reporting

The use of standardized macros and consistent reporting formats throughout clinical programs boosts operational efficiency. SDTM's standardized dataset structure enables the efficient reuse of macros and uniform formats for tables, listings, and figures, crucial for streamlined regulatory reviews.

Regulatory Submission-Ready Data

Utilizing data formatted as CDISC SDTM SAS transport files or datasets ensures compliance with the preferred formats of regulatory bodies such as the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). This practice not only smoothens the review process but also minimizes administrative overhead and accelerates the approval timeline.

Quality Enhancement Through SDTM Framework

The second efficiency in using CDISC SDTM with your ISS/ISE is how SDTM's structured format improves data quality by enforcing clear definitions and documentation standards. This clarity reduces the likelihood of errors and discrepancies in the data. It also promotes interoperability by ensuring that data from different sources and studies can be integrated seamlessly. This interoperability eliminates the need for extensive data mapping and reconciliation efforts, thereby increasing accuracy, reliability and reducing the risk of errors and inconsistencies in ISS and ISE summaries. In addition to this the SDTM framework also enhances quality in the integrated summary submission with the following:

Robust Data Validation and Preparation

Rigorous quality control measures, including double programming for SDTM mapping and thorough validation of data for appropriateness and completeness, are imperative. These practices ensure that the integrated datasets meet the exacting standards required for regulatory submissions.

Consistency and Compliance

Maintaining consistency in coding across studies using the same dictionaries and versions, and adhering to the same version of the Implementation Guide (IG) for all SDTM domains, bolsters both the quality and reliability of the data.

Thorough Documentation

Proactively preparing submission-ready documents throughout the project lifecycle and reducing the number of review cycles are strategic approaches that enhance the documentation process. The creation of define.xml files for individual studies and a comprehensive define.xml for integrated summaries, coupled with detailed quality control plans, ensures all documentation is comprehensive and compliant with electronic Common Technical Document (eCTD) requirements.

Conclusion

To conclude, implementing CDISC SDTM standards in the creation of Integrated not only streamlines the regulatory submission process but also significantly enhances the quality and reduces the costs of these critical documents. The adoption of a standardized structure and uniform data presentation, as recommended by regulatory bodies like the FDA, ensures that submissions are not only compliant but also more readily reviewed and approved. Furthermore, the integration of advanced programming techniques and automation in data handling and report generation can provide substantial cost efficiencies and improve data reliability. As regulatory requirements continue to evolve, staying abreast of CDISC SDTM updates and integrating these into your submission processes will remain essential.

Related Blog Posts 

• Integrated Summaries of Safety & Efficacy for Regulatory Submissions
• Creating Custom or Non-Standard CDISC SDTM Domains 
• CDISC SDTM v3.1.2 Theory and Application