Beyond XPT: Reimagining the Clinical Submission for 2041

About this session

Part of Session 7, Track C: Special Topics (Chair: Donna Sattler, Eli Lilly).

The SAS Version 5 transport file has been the industry standard for two decades, but its limitations 8-character variable names, two data types, no embedded metadata, no compression, and software dependency are increasingly incompatible with current and future clinical trials involving wearables, genomics, and EHR-linked real-world data. The evolving AI regulatory environment demands data exchange formats that are queryable, semantically rich, and metadata complete.
Rather than a single replacement, next-generation submissions in 2041 will involve a use-case-driven strategy (Dataset-JSON for SDTM/ADaM, Parquet for sensor data and Fast Healthcare Interoperability Resources for real-world data) for accelerated sponsor preparation and regulatory review. Open-source validators and converters can reduce adoption barriers. We explore advanced data exchange formats against next-generation submission requirements, including data type richness, metadata integration, compression, and queryability. We also outline a phased, backwards-compatible adoption path toward continuous, API-driven regulatory data exchange.

Speakers

• RC

  Rajprakash Chennamaneni

  Jazz Pharmaceuticals

  Speaker

• DS

  Donna Sattler

  Eli Lilly

  Chair