Clinical Biomarkers And Associated Data Types

Among clinical biomarkers, the genomic and imaging data types are creating the greatest IT challenges. By recommending CDISC's SDTM (see above) as the standard for drug submission, the FDA has taken an important step toward the integration of genomic and imaging data with conventional clinical patient data. CDISC SDTM is an easily extendable model that incorporates the FDA submission data structures. Based on strong collaboration between the biopharmaceutical industry, clinical research organizations, clinical trial investigator sites, IT vendors, and the FDA, SDTM represents the collective thoughts from a broad group of stakeholders.

Conventional clinical data are categorized into four classes, subdivided into domains, of the SDTM data model:

1. Events include specific domains covering adverse events, subject disposition, and medical history.

2. Interventions cover exposure (to study drug), concomitant medications, and substance use.

3. Findings contain the assessment information, such as electrocardiogram, lab, physical exam, vital signs, and subject questionnaire data.

4. The other class was created to group specialized categories of information such as trial design, supplemental qualifiers, trail summary, and related records, where related records provide linkages across the different files.

To support biomarker data submission, two new SDTM domains have been added:

Parent Domain:

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