What role does conditional processing play in tailoring clinical trial documentation for different study phases, patient populations, and clinical endpoints?

November 10, 2023
|By Bryan Tipper

Conditional processing in DITA XML plays a pivotal role in tailoring clinical trial documentation to meet the specific requirements of different study phases, patient populations, and clinical endpoints. This capability enables content authors to create flexible and adaptive documents that can selectively include or exclude information based on predefined conditions.

Tailoring for Study Phases

In clinical trials, information often varies across different study phases, such as pre-clinical, phase I, phase II, and phase III. With conditional processing, DITA allows authors to define conditions associated with each phase. For instance, content related to phase-specific protocols, endpoints, or patient recruitment criteria can be tagged with conditional attributes. During document generation, the appropriate content is included based on the active study phase, streamlining documentation efforts and reducing the risk of errors.

Adapting to Patient Populations

Pharmaceutical clinical trials may involve diverse patient populations, each requiring specific information. DITA enables the tagging of content with conditions related to patient characteristics, such as age groups, gender, or medical history. This ensures that documentation caters to the needs of particular patient cohorts while maintaining a single source of truth. As patient populations evolve, the documentation can easily adapt to reflect these changes.

Conditional Processing Example:

Here’s an example of how conditional processing can be applied in DITA for tailoring clinical trial documentation:


<topic id="patient_recruitment_criteria">
  <title>Patient Recruitment Criteria</title>
  <body>
    <p>Common Criteria for All Patients</p>
    <conditioned-text audience="Pediatric">
      <p>Additional Criteria for Pediatric Patients</p>
    </conditioned-text>
    <conditioned-text audience="Elderly">
      <p>Additional Criteria for Elderly Patients</p>
    </conditioned-text>
  </body>
</topic>

In this example, the “Patient Recruitment Criteria” topic includes common criteria for all patients and conditions for pediatric and elderly patients. During document assembly, the appropriate criteria are included based on the defined audience conditions, ensuring tailored documentation.