Enhancing Stakeholder Engagement in CDISC Standards Development: The Role and Impact of the CDISC Advisory Council Task Force

An open consensus process is the cornerstone of standards development as it ensures that comments are considered, using fair, efficient, impartial, and transparent processes. CDISC has a robust standards development process (Figure 1) that includes several opportunities for consensus building including volunteering on development teams as well as participating in Internal and Public review cycles (1).

Figure 1: CDISC Standards Development Process

However, CDISC is always looking for opportunities to enhance stakeholder input, especially early in the standards development process. One recent enhancement was the creation of a Task Force within the CDISC Advisory Council (CAC). The CAC plays an important role in shaping CDISC’s development and direction and is comprised of CDISC Platinum Member representatives. The goal of the newly formed CAC Task Force is to secure early input and acceptance of standards by leveraging both the depth and the breadth of experience that exists within the CAC.

The first goal of the CAC Task Force was to evaluate the impact of the proposed changes to the Study Data Tabulation Model Implementation Guide (SDTMIG) 4.0 (Table 1) before entering the Internal Review cycle. While not in the early stages of development, updates to the SDTMIG are impactful to stakeholders and thus input at any stage of development is valuable (2). The Task Force was asked to evaluate each major change by providing feedback on whether their individual organization accepted the proposed change, as well as the effort (scale of 1-5 with 5 representing the highest level of effort) required to modify process documents, modify programs, and validate programs. A total of 14 CAC companies participated in these discussions with 12 companies completing the assessment (Table 2). Overall, there was high acceptance of the proposed SDTMIG 4.0 changes. When there were concerns, the following common concerns across topics emerged:

• ?Change acceptance and alignment across the US Food and Drug Administration (FDA), Japan Pharmaceutical and Medical Devise Agency (PMDA), and other regulatory health authorities.
• The update did not provide sufficient benefit to justify change.
• Requirement of an organization to update an internal strategy that had been successfully used in a submission.
• Preference for an alternate implementation solution.

There were two outliers in terms of effort and acceptance. The outlier in effort is the high effort that will be required to implement the proposed strategy for the handling of data in studies where subjects can re-screen or participate in the same study more than once. However, Task Force members stated that this has been a longstanding issue across industry and there was strong support to have a standard solution. The outlier in acceptance was the proposed QRS Instrument Reference (QX) Domain which allows sponsors to provide information about a QRS instrument in a structured format. This proposed change was accepted by only 33.3% of Task Force members. The strongest concern raised was the potential misalignment with the November 2023 FDA Technical Specification on Clinical Outcome Assessments which proposes using a custom dataset (ZQ) to submit instrument level information (3). At the time of the discussion, the development team had not done a full evaluation of the FDA COA Technical Specification. Due to this Task Force concern, CDISC asked the development team to complete this assessment and confirm alignment before proceeding with development. The development team will present their findings and potential changes needed to harmonize with the FDA approach to the Task Force.

The CAC Task Force has proven to be a valuable forum to gain additional stakeholder feedback. This evaluation exercise of the SDTMIG 4.0 highlights that the effort to implement a change is not necessarily predictive of acceptance by stakeholders. Moving forward, the CAC Task Force will be involved in reviewing Standard Development Proposals before initial modeling occurs to ensure that the proposed solutions meet stakeholder needs and ensure broad support across industry.

Table 1. SDTMIG 4.0 Major Updates

Table 2. Acceptance of and Effort to Implement SDTMIG 4.0 Major Updates

Conclusion

The development and implementation of data standards are crucial for ensuring consistency, quality, and interoperability in clinical research. CDISC's robust standards development process, characterized by its open consensus model, plays a pivotal role in achieving these goals. The recent formation of the Task Force within the CDISC Advisory Council (CAC) marks a significant enhancement in stakeholder engagement, providing a valuable forum for early input and acceptance of proposed standards.

The Task Force's evaluation of the proposed changes to the Study Data Tabulation Model Implementation Guide (SDTMIG) 4.0 underscores the importance of this early engagement. The high level of participation and the insightful feedback gathered highlight the diverse perspectives and expertise within the CAC. Despite some challenges, such as the varied acceptance and effort required for different updates, the overall support for the changes indicates a strong alignment with stakeholder needs.

Moving forward, the CAC Task Force will continue to play an integral role in the standards development process, ensuring that proposed solutions are well-vetted and broadly supported across the industry. This proactive approach not only enhances the quality and relevance of CDISC standards but also fosters a collaborative environment where stakeholder contributions are valued and effectively integrated. As the landscape of clinical research evolves, such initiatives will be vital in maintaining the robustness and usability of data standards, ultimately contributing to the advancement of global health research.

References

1. https://www.cdisc.org/sites/default/files/2023-12/CDISC-COP-001-Standards_Development_Nov%20_2023_Final_Approved.pdf ??
2. https://www.cdisc.org/standards/foundational/sdtm
3. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-clinical-trial-datasets-and-documentation-clinical-outcome-assessments-using-item