CDISC Standards Implementation


Adopting the Middle-to-End Standards Approach for Efficient Analysis and Reporting

Companies within the pharmaceutical/biotech industry have adopted the use of various functional and therapeutic CDISC standards, according to regulatory recommendations or requirements for submission of clinical data. Even though it might, theoretically, be ideal to have a true End-to-End approach using the foundational standards from Protocol Representation Model to ADaM/Define.xml and multiple therapeutic area standards, this requires a considerable amount of time, effort, and resources to coordinate that concept across functional areas of Data Management, Clinical Data Services, and Clinical Biostatistics and Programming. The landscape for these standards continues to expand, as they are extended to address different study types and designs.

From the analysis and reporting perspective, SDTM and ADaM, which start in the middle of the data life cycle process, are key standards (outlined in red in Fig. 1 End-to-End data collection, analysis and reporting submission below). ADaM implementation can be considered to be the most challenging because of the large variation in types of derivations and their complexity. A suite of standard code at the study or global level around those data standards is sometimes developed in order to improve efficiency in safety analysis and reporting (A&R) to produce Tables, Listings, and Figures (TLFs), on the backend of the process.

Fig. 1 End-to-End Data Collection, Analysis and Reporting, Submission

Middle-to-End Standards Approach

A Middle-to-End standards approach can be used to leverage SDTM and ADaM, including implementation of a standard mapping specifications template, standard template code programs which create ADaM datasets from SDTM safety domains (listed in Fig. 2 Safety Domains/Datasets below), and standard A&R programs. A good way to envision this approach is to think of it as: SDTM to ADaM + Standard TLF Reporting = Efficient A&R.

The mapping specs contain the metadata for both ADaM 2.1 and Define.xml v2.0. The standard ADaM template code is based on standard TLF mocks and ADaM 2.1, the ADaM IG 1.1 and ADaM OCCDS v1.0.

Fig. 2 Safety Domains/Datasets

Advantages of the Middle-to-End Approach

The standard programs have the flexibility to easily output reports in either listing, ODS, RTF, or TXT format. These are functional macros which are used to set the environment, perform analysis, create a core datasets, format data for efficient generation of standard safety TFLs from ADaM datasets and a titles and footnotes metadata file, based on presentation standards layout. The overall standards have been vetted and thoroughly time tested and the tools have been validated thus ensuring the highest quality while accelerating delivery to our sponsors.

If you would like to know more about the Middle-to-End standards approach and how it leads to more efficient analysis and reporting, please contact Valerie Williams, Manager Statistical Reporting Standards, ICON Clinical Research at Valerie.Williams@iconplc.com.