概要
Evidence suggests that capturing clinical outcome assessment data electronically (eCOA) has many benefits over paper. However, barriers to adoption still remain. Poor adoption is in part attributable to unfamiliarity with benefits, but also poor experiences during study start-up, absence of clear expectations among sponsors and vendors, and misalignment among all stakeholders. This is also an area where no formal training exists for sponsors or eCOA providers. This short course is designed to introduce participants to key eCOA topics including:
- Benefits of and barriers to eCOA adoption
- Regulatory guidance applicable to eCOA vendors
- Key measurement science and design principles applicable when using eCOA
- Considerations when choosing a solution for your study based on study design and patient population
- Start-up processes and considerations for migrating from paper to electronic modes of data collection, developing specification documents, and conducting user acceptance testing
- Role of sponsors and sites in the trial technology implementation process and in optimizing quality of data collected with eCOA
- Best practice recommendations for training site staff and study subjects on eCOA data collection in clinical trials
- Considerations for the use of bring your own device (BYOD) in clinical trials
The interactive short course, created in collaboration with the Critical Path Institute’s ePRO Consortium, will provide real world examples and case studies including challenges and proposed solutions for the audience to work through in small groups.