Webinar Recap: Clinical Outcome Assessments and Enhancing Inclusivity

Reducing Bias in Clinical Outcome Assessments

Pearson began the webinar by covering the four key types of COAs, which are:

• Patient-reported outcomes
• Observer-reported outcomes
• Clinician-reported outcomes
• Performance outcome measures

The presenter then discussed how COAs are used in clinical trials, schools, hospitals, and correctional facilities. They expounded on Pearson’s many initiatives to reduce and eliminate bias from COAs. These include:

• Ensuring gender neutrality
• Avoiding stereotypes
• Regularly updating tests to reflect current demographics

Pearson shared its rigorous test development process, which minimizes bias. They use a global item set in test development, ensuring tests are translatable and culturally appropriate across different regions. Pearson's tests are published in multiple languages and undergo thorough review to eliminate bias and ensure inclusivity.

Lionbridge’s Clinical Outcome Assessment Translations

Next, Lionbridge’s presenter shared the steps of a linguistic validation process and reviewed how these regulatory translations ensure accurate, culturally sensitive translations of clinical trial materials. Linguistic validation is vital because it helps:

• Maintain conceptual equivalency
• Ensure easy interpretation
• Achieve comparability across languages and cultures

The Lionbridge presenter shared how the optimal linguistic validation process should involve native speakers and clinicians in the translation process. With their linguistic and industry expertise, they’re effective at deciding if content is appropriate and understood by the target audience. Additionally, a diverse set of participants should be involved in the cognitive debriefing to audit if materials are inclusive to the target population.

Next, the presenter elucidated upon the general steps in linguistic validation: 

• Translatability assessment
• Concept elaboration
• Dual forward translation
• Single or dual-blinded back translation
• Comparative review and resolution
• International Harmonization
• Clinician Review or Cognitive debriefing
• Format check and proofreading

Questions about Clinical Outcome Assessments

In the last section of the webinar, participants asked the presenters a few questions. Participants asked presenters about:

• Appropriate norms in Alzheimer's trials
• Effectiveness of back translation
• Time required to develop and translate new instruments
• Role of AI in enhancing inclusivity in translations

When answering the questions, the presenters repeatedly stressed the importance of using modern, culturally fair tools to measure participant outcomes and feedback. They also emphasized constantly questioning and testing industry norms to continue improving the COA translation and localization process. 

Get in touch.

Ready to explore COA translation and COA localization for your clinical trial translation needs? Lionbridge has decades of experience supporting life sciences customers, both via pharma and medical device translation services. You can count on Lionbridge to partner with you and ensure life sciences regulatory compliance.