W-07: Aligning Strategies and Deliverables for Global eCOA Translation Submissions to Ethics Committees in Clinical Trials
Poster Presenter
Shawn McKown
Senior Director and Practice Lead, Linguistic Validation
RWS Life Sciences United States
Objectives
The objective of this study is to describe and analyze the challenges associated with submission of translated eCOA materials to ethics committees during global clinical trials, and to provide specific strategies to improve and standardize the process.
Method
RWS Life Sciences reviewed the eCOA translation submission process in 25 recent clinical trials, which included ethics submissions into more than 50 countries. For each, we reviewed and analyzed submissions requirements and timeline misalignments to draw conclusions and make process recommendations.
Results
Clinical trials analyzed (n = 25) ranged in scope from requiring submissions in one country to requiring submissions in 40 countries. For each trial, our team collected data regarding specific submissions requirements, including acceptability of draft translations and eCOA screenshot requirements. In addition, for each trial we collected and reviewed data indicating the degree to which misaligned timelines led to situations where final translated eCOA screenshots were not available by ethics submission deadlines. Our results indicated substantial variety and unpredictability on the question of acceptability of draft translations, with over 50% of reviewed studies requiring both draft and final translations on either a country- or site-specific basis. Review of timeline misalignments indicated that study teams for over 60% of reviewed trials did not have access to ethics submissions deadlines for all countries at the time of eCOA translation initiation, which led to timeline misalignments between the sponsor, eCOA vendor, and linguistic validation vendor.
Conclusion
Frequently, clinical trial teams are confronted with misalignment between submission deadlines and the linguistic validation/eCOA development timelines provided by vendors. In addition, submission requirements vary radically across global ethics committees, making alignment of deliverables difficult to achieve. Our results indicate the importance of ensuring that eCOA and Linguistic Validation vendors are appropriately aligned from a contracting and timelines perspective, as well as ensuring that development timelines are made transparent to clinical trial teams during the site selection process. Further, we propose further standardization of ethics submission deliverables across countries, taking into account that many ethics committees present inconsistent requests with regard to COA format (screenshot/paper) and acceptability of draft translation submission. Contingency strategies designed to manage unanticipated committee requests, including re-use of existing eCOA translation screenshots and early preparation of paper draft translations when necessary, should be developed.
