Implementing electronic patient reported outcome data capture for multi-centre oncology clinical trials

Abstract Background:Traditionally patient reported outcomes (PRO) are collected on paper as key endpoints for clinical trials. With increasing internet usage there is an interest in the use of electronic patient reported outcomes. Although previous studies in the general oncology clinical setting have shown the equivalence of scores in paper and electronic formats, there is a wide ranging level of uptake of electronic patient reported outcome acceptance amongst trial patients.Implementation plan:We have chosen to implement the use of electronic patient reported outcomes in our clinical trial population using a study within a trial (SWAT) to assess functionality and acceptability to patients. This will be led by a multi-disciplinary team of project managers, methodologists, clinicians and data scientists. The implementation plan has multiple ethical and regulatory considerations required in system identification, patient and public involvement and the design of a SWAT. Conclusion: Implementation of ePRO even in a world of increasing technology use is a complex and multifactorial project requiring careful consideration and adequate resourcing.