Balancing Innovation and Propriety: The Question of Copyright Holder’s Opinions on GenAI Usage While Localizing Their Intellectual Property
Author(s)
Megan Duff, MA, BA1, Kathryn M. Nolte, MSc, BA, BS2, Stephanie Casale, MA3, Melinda J. Johnson, MA4.
1Lionbridge, Clayton, NC, USA, 2Lionbridge Technologies, Waltham, MA, USA, 3Lionbridge Technologies, Alanson, MI, USA, 4Director, Global COA Operations, Lionbridge, Cary, NC, USA.
1Lionbridge, Clayton, NC, USA, 2Lionbridge Technologies, Waltham, MA, USA, 3Lionbridge Technologies, Alanson, MI, USA, 4Director, Global COA Operations, Lionbridge, Cary, NC, USA.
OBJECTIVES: The question of integration of Generative Artificial Intelligence (GenAI) into clinical trial operations, particularly concerning Clinical Outcome Assessments (COA),is hampered by a lack of clear guidance regarding GenAI’s application to COA intellectual property. This uncertainty has slowed the adoption of GenAI in critical areas such as COA linguistic validation and migration, which are vital for incorporating the patient voice. This study aimed to collect and disseminate COA copyright holders’ perspectives on GenAI usages in these processes to inform future deployment strategies.
METHODS: A ten-question survey was provided to 100 COA copyright holder contacts to ascertain their a) general perspectives on GenAI usage while localizing copyrighted COA, and b) perspectives of specific uses of GenAI within the linguistic validation and migration processes.
RESULTS: Preliminary results indicate broad copyright holder acceptance for general usage of GenAI in COA localization and adaptation. However, confidence levels decreased significantly when asked about specific, high-stakes use cases, such as GenAI-led cognitive interviews.
CONCLUSIONS: Our findings demonstrate that COA copyright holders are largely receptive to GenAI integration into the linguistic validation and eCOA migration processes, recognizing its potential to accelerate clinical trial start-up and enhance the patient voice. This willingness is contingent on which tasks GenAI would be leveraged on, as well as the implementation of robust human led and quality control processes. This research suggests that GenAI can indeed amplify value and access in patient-centered COA initiative. Further research will involve in-depth interviews with copyright holders to further interpret these findings and develop best practice recommendations.
METHODS: A ten-question survey was provided to 100 COA copyright holder contacts to ascertain their a) general perspectives on GenAI usage while localizing copyrighted COA, and b) perspectives of specific uses of GenAI within the linguistic validation and migration processes.
RESULTS: Preliminary results indicate broad copyright holder acceptance for general usage of GenAI in COA localization and adaptation. However, confidence levels decreased significantly when asked about specific, high-stakes use cases, such as GenAI-led cognitive interviews.
CONCLUSIONS: Our findings demonstrate that COA copyright holders are largely receptive to GenAI integration into the linguistic validation and eCOA migration processes, recognizing its potential to accelerate clinical trial start-up and enhance the patient voice. This willingness is contingent on which tasks GenAI would be leveraged on, as well as the implementation of robust human led and quality control processes. This research suggests that GenAI can indeed amplify value and access in patient-centered COA initiative. Further research will involve in-depth interviews with copyright holders to further interpret these findings and develop best practice recommendations.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO24
Topic
Clinical Outcomes, Organizational Practices, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas