Towards a Patient Recruitment System for Clinical Trials: A Mixed-Methods Study about the Status Quo & User Requirements at 10 University Hospitals (Preprint)

BACKGROUND Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. IT support -- patient recruitment systems -- may help to overcome existing challenges and improve recruitment rates, when fitted to the user needs and environment. OBJECTIVE The goal of our research is to describe the status quo of patient recruitment processes and identify user requirements for the development of a patient recruitment system. METHODS We conducted an online survey with 56 participants and semi-structured interviews with 33 participants from ten German university hospitals. RESULTS We report the recruitment procedures and challenges of ten university hospitals. The recruitment process is influenced by diverse factors, such as the ward, the use of software, and the study inclusion criteria. Overall, clinical staff seems more involved in patient identification, while research staff focuses on screening tasks. Ad-hoc as well as planned screening is common. Identifying eligible patients is still associated with significant manual efforts. Recruitment staff use Office applications since no tailored software is available. For such software, data from disparate sources will need to be made available. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, to support to development of a successful system. CONCLUSIONS To make use of the high potential of IT for patient recruitment, many technical and process challenges still have to be solved. Based on their recruitment workflows and experience, our participants identified requirements, which a successful patient recruitment system has to fulfill. Prospective users should be involved in the subsequent design and development steps.