SOLADIS, CDISC MEMBER FOR ITS BIOMETRICS ACTIVITIES

WHY JOIN CDISC?

The CDISC(Clinical Data Interchange Standards Consortium) is an international grouping created in 1997, which proposes standard formats for the collection (CDASH), submission (SDTM) and analysis (ADaM) of data in clinical research. The aim of these standards is to facilitate the flow of data from the patient record to statistical analysis and archiving.

CDISC’s ambition is to clarify Clinical Research by bringing together a worldwide community of experts whose mission is to advance standards for data processing. The aim is to make data more accessible, interoperable and reusable, thereby contributing to meaningful and effective research, with a greater impact on global health.

Regularly confronted with SDTM and ADaM issues on behalf of our pharma/biotech customers, Soladis has been a member of CDISC for several years, in order to keep abreast of regulatory developments in these standards.

As a loyal participant in CDISC events and the GUF (Groupe des Utilisateurs Francophones des standards CDISC), we see this membership as a guarantee of staying at the forefront of progress in the sector.

WHAT ARE SDTM AND ADAM?

SDTM(Study Data Tabulation Model) is a data tabulation model. It was the first standard developed by the CDISC working groups. This model structures data according to the framework defined in the SDTM and SDTMIG (Implementation Guide) documents.

SDTM tables take the form of a series of domains (datasets DM, AE, CM, etc.) built from raw data. Information specific to each subject is grouped together in the corresponding domains. For example, a patient’s medical history may be grouped in the “MH” (Medical History) dataset, laboratory results in the “LB” (Laboratory) dataset, and adverse events in the “AE” (Adverse Event) dataset.

Ideally, the CRF database can be built in CDASH, a suitable format that suggests the best way of collecting data to facilitate subsequent processing and transformation into SDTM.

The content of these datasets, and the way in which tables are generated, must be described in the metadata (via a define.xml file).

The SDTM formalism ensures similar basic structures for all studies. Data can be appropriated more quickly, and processing time optimized (e.g. the treatment exposure table for study A will have the same form as that for study B). Tables and reports (e.g. patient profiles) can be created more quickly, and the statistical analysis process can be more efficient.

The ADaM (Analysis Data Model) is a standard for submitting statistical analysis data. It takes the form of a series of datasets (ADSL, ADAE…) built from SDTMs and derived variables required for statistical analysis. This formalism makes it possible to harmonize the analysis and trace the statistical result (where the data comes from, how it was processed, on which population, etc.). It allows for comparability of results and a better understanding of the conclusions drawn from statistical analysis.

An implementation guide (ADAMIG) developed by CDISC must be followed for the creation of these datasets. The content of the datasets and the way in which the results tables are generated must be described in the metadata.

The FDA requires the production of structured and documented datasets for submissions; ADaM is the most widely recognized format.