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cognitive-debriefing-hae-phase-iii-tria

Overview

Sesen supported a global biopharmaceutical sponsor in conducting cognitive debriefing for a Phase III clinical trial focused on hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. The study required multilingual patient interviews to validate a newly translated patient-reported outcome (PRO) instrument across 22 languages. As part of the linguistic validation process, Sesen ensured the conceptual equivalence, clarity, and cultural appropriateness of each translation to meet ISPOR COA compliance standards. Our clinical linguistics services helped confirm that patients across regions could consistently interpret and respond to the instrument, enabling its regulatory acceptance and global deployment within the trial protocol.

Project Background

A global biopharmaceutical company engaged Sesen to support a large-scale Phase III clinical trial evaluating the efficacy and safety of an on-demand treatment for hereditary angioedema (HAE), a rare and chronic genetic condition marked by unpredictable and potentially life-threatening swelling episodes. To meet FDA and EMA regulatory requirements, the sponsor needed validated patient-reported outcome (PRO) instruments capable of capturing meaningful patient feedback across linguistically diverse populations.

The study required cognitive debriefing and linguistic validation of the PRO instrument in 22 target languages, covering key regions including North America, Europe, Latin America, and Asia-Pacific. These multilingual patient interviews were essential to confirm conceptual equivalence, clarity, and cultural relevance of the instrument, ensuring consistent interpretation across all participant groups. The validated translations would be incorporated into the clinical trial protocol and submitted as part of the regulatory package.

Objectives

Goal:
The primary objective was to ensure the conceptual equivalence, linguistic clarity, and cultural appropriateness of a patient-reported outcome (PRO) instrument used in a Phase III clinical trial targeting adolescent and adult patients diagnosed with hereditary angioedema (HAE). The validated instrument needed to accurately capture patient experiences across multiple languages and regional contexts in compliance with global regulatory standards.

Sub-goals:

  • Assess comprehension, interpretability, and emotional resonance of translated content through age-appropriate cognitive debriefing interviews
  • Evaluate cross-cultural relevance and identify potential misinterpretations in localized versions
  • Generate regulatory-grade documentation of content validity in accordance with ISPOR and FDA guidance on COA instrument validation
  • Finalize and certify 22 language versions of the PRO instrument for integration into the trial protocol and deployment across all global study sites

Approach and Methodology

Sesen employed a rigorous, standards-driven approach to cognitive debriefing, aligned with ISPOR guidelines, FDA PRO guidance, and EMA expectations for linguistic validation of clinical outcome assessments (COAs). Our methodology ensured each translated PRO instrument version was culturally appropriate, clearly understood, and conceptually equivalent across all patient populations.

Participant Recruitment
Patients were recruited from 22 language groups across North America, Europe, Latin America, and Asia-Pacific. The cohort included both adolescents and adults with a confirmed diagnosis of hereditary angioedema (HAE), ensuring representation of age- and region-specific linguistic and cognitive profiles.

Interview Design
Sesen developed age-stratified interview protocols with customized cognitive probes to assess comprehension, contextual relevance, and emotional resonance. Probes were tailored to uncover potential ambiguities or misinterpretations across both younger and adult populations.

Execution
Trained native-speaking linguists and in-country moderators conducted the interviews using a hybrid model of virtual and in-person sessions. This flexible delivery approach improved recruitment feasibility while maintaining consistency and quality across global regions.

Protocols Followed
All activities adhered to the ISPOR Principles of Good Practice for the Translation and Cultural Adaptation Process, along with FDA and EMA guidance on PRO instrument validation. Interview flow, participant interactions, and feedback documentation followed regulatory expectations to support submission-readiness.

Documentation
Sesen compiled detailed transcripts, structured debriefing reports, and language-specific summary analyses. These deliverables provided regulatory-grade evidence of conceptual equivalence, supporting the inclusion of all 22 translated PRO instruments in the trial protocol and ClinicalTrials.gov registration.

Challenges and Solutions

Conducting cognitive debriefing across 22 languages for a rare disease clinical trial required careful planning to navigate linguistic, cultural, and operational complexities. Sesen applied a proactive and standards-based approach to address the following challenges:

Challenge: Ensuring consistency across 22 culturally diverse populations
Multinational clinical trials demand high levels of linguistic alignment to ensure that PRO instruments maintain the same meaning across languages and regions.
Solution: Sesen implemented standardized moderator training across all language teams, reinforced by centralized quality control (QC) protocols. This ensured consistent interview delivery, accurate probe execution, and harmonized data collection in accordance with ISPOR and regulatory expectations.

Challenge: Adolescents’ varying literacy and comprehension levels
Participants in the adolescent subgroup displayed a broad range of reading abilities, requiring tailored methods to evaluate understanding without introducing bias.
Solution: Sesen used simplified cognitive probes and scenario-based questioning techniques adapted for younger patients. These age-appropriate tools supported reliable data collection while preserving the integrity of the linguistic validation process.

Challenge: Scheduling in rare disease populations
Patients with hereditary angioedema are geographically dispersed, making recruitment and scheduling for debriefing interviews more complex.
Solution: Sesen adopted a hybrid model combining virtual and in-person interviews. Flexible scheduling options allowed for increased participation across time zones while maintaining data quality and protocol compliance.

Results

Sesen successfully delivered validated, culturally appropriate PRO instruments across 22 languages, enabling the sponsor to meet global regulatory and operational milestones for their Phase III clinical trial on hereditary angioedema (HAE).

  • All 22 translated language versions were finalized on schedule with no delays caused by back-translation or reconciliation issues
  • Final translations were reviewed and approved by the sponsor for inclusion in the trial protocol and related regulatory documentation
  • The validated PRO instruments were registered with ClinicalTrials.gov, supporting transparency and regulatory alignment
  • Sesen’s linguistic validation process met FDA, EMA, and ISPOR requirements for content validity and cross-cultural equivalence
  • The clinical trial was launched across more than 30 sites in five continents, supported by harmonized patient-facing materials
  • The sponsor commended Sesen for delivering high linguistic accuracy and consistent execution of cognitive debriefing interviews across all regions

These outcomes positioned the study for successful data collection and compliance, reinforcing Sesen’s role as a trusted provider of clinical linguistics and cognitive debriefing services.

Why Sesen

The sponsor selected Sesen based on our proven expertise in clinical linguistics and our exclusive focus on life sciences translation and validation services. Our ability to deliver high-quality, regulator-ready translations across therapeutic areas made us the ideal partner for this global Phase III trial on hereditary angioedema (HAE).

  • Life sciences specialization: Sesen works exclusively within the life sciences sector, offering deep subject matter expertise in rare diseases, regulatory documentation, and clinical trial communications
  • Global linguist network: Our vetted linguists are professionally trained in patient-reported outcome (PRO) translation and cognitive debriefing protocols, ensuring cultural and linguistic precision across all target populations
  • Quality certifications: Sesen is certified under ISO 17100 (translation services), ISO 9001 (quality management), and ISO 13485 (medical device quality systems), reinforcing our commitment to compliance and operational excellence
  • Regulatory alignment: Our teams are fluent in ISPOR, FDA, and EMA requirements for linguistic validation of clinical outcome assessments, enabling seamless integration of validated instruments into submission packages
  • Responsive project execution: With dedicated project managers and age-specific interview methodologies, Sesen ensured streamlined coordination across global sites while adapting protocols to meet adolescent and adult participant needs

These differentiators allowed Sesen to exceed client expectations while ensuring linguistic consistency, regulatory compliance, and successful global deployment.

Client Testimonial

“Sesen’s team provided exceptional linguistic expertise and patient-centered support. Their cognitive debriefing execution was seamless and regulator-ready.”

— Global Clinical Outcomes Lead, Top 20 Biopharmaceutical Company

This feedback highlights Sesen’s strength in delivering high-quality cognitive debriefing services that meet global regulatory standards while maintaining a strong focus on patient engagement and linguistic accuracy. Our tailored approach to multilingual PRO validation continues to earn the trust of leading pharmaceutical sponsors conducting complex, multinational clinical trials.

Need Multilingual Cognitive Debriefing for Your Global Trial?

Work with Sesen to ensure your PRO instruments are validated for regulatory compliance and cultural relevance across diverse patient populations. Our expert teams support cognitive debriefing and linguistic validation in over 150 languages for all clinical trial phases.

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