ECOA LICENSING- LESSONS LEARNED FROM THE COPYRIGHT OF COA TRANSLATIONS AND SPECIFICITIES OF ECOAS
Author(s)
Anfray C1, Conway K2, Acquadro C2
1Mapi, Lyon, France, 2Mapi Research Trust, Lyon, France
Presentation Documents
OBJECTIVES Electronic Clinical Outcome Assessments (eCOAs) are increasingly being used in clinical trials and their use is encouraged by regulatory authorities. Licensing is a key issue for their appropriate utilization. The objective of this abstract is to make recommendations about eCOA licensing using lessons learned from the COA translation licensing. METHODS Publications about licensing of COA translations were searched and a review of the eCOAs specificities was performed using information available from e-vendors. RESULTS Very few publications exist about the licensing of COA translations. The ISOQOL TCA SIG has developed a draft reflection paper which considers that translations are derivative work of original questionnaires. As such, they recommend that the copyright of a COA and its translations should be owned by a unique entity, generally the original developer to harmonize and facilitate conditions of access and use. They state that distribution should be centralized to facilitate access to questionnaires, maintain reliable information about them, and control their use. Review of the e-vendors information shows that eCOAs are often customized, with proprietary devices and softwares, and cannot be shared across users. As a consequence, there is a multiplication of e-versions for a same content. Equivalence between paper and e-versions and between e-versions is then a major concern. The review also shows that migration from paper to the electronic platform/device implies changes to the content and format of the paper version. Therefore the eCOAs can be considered as derivative works of an original COA and lessons learned from copyright of translations may apply. Examples will be provided. CONCLUSIONS Centralized copyright ownership by the owner of the original COA and centralized licensing process for eCOAs should be discussed with all stakeholders to help controlling use and users and to protect the integrity of the instrument across e-versions by providing clear rules of e-implementation.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PRM59
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
Multiple Diseases