OBJECTIVES: The FDA has previously noted that data reported directly by patients about how they are feeling and functioning (i.e. patient reported outcomes (PROs)) are rarely included in oncology drug labelling claims in the United States, with end points relating to survival, imaging and biomarkers tending to take priority. However, while research suggests an increase in PRO use in oncology trials, significant challenges remain and a low burden solution for all stakeholders is becoming increasingly important. METHODS: Key challenges for integrating PROs into oncology clinical trials were identified based on study protocols, sponsor feedback and best practices from previous oncology studies. Based on this feedback an electronic solution for capturing data in oncology studies was developed. RESULTS: Patient and site burden were identified as key challenges in oncology studies deploying PROs. Oncology patients can be very impaired, so requiring the completion of lengthy questionnaires can result in non-compliance. A user focused electronic system reduces the burden of patients providing answers to questionnaires, and opens the possibility for data capture to occur at home rather than at study visits. Feedback also highlighted that sites struggle with organizing visits and staying protocol compliant. An electronic visit scheduling tool can help sites keep track of what order and at which visits questionnaires should be completed and to help remind and reschedule patient visits. CONCLUSIONS: Obtaining a proper understanding of the patients experience in oncology clinical studies is increasingly becoming a priority for multiple stakeholders, not least the patients themselves. While there is evidence that the number of PROs being included in oncology studies is increasing over time there are still significant challenges to capturing high-quality PRO data. A holistic electronic solution, which considers both the patients and sites experience of providing data, can reduce the barriers to capturing high-quality PRO data.