Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals

Abstract

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. Information technology (IT) support systems—for instance, patient recruitment systems—may help overcome existing challenges and improve recruitment rates, when customized to the user needs and environment. Objective The goal of our study is to describe the status quo of patient recruitment processes and to identify user requirements for the development of a patient recruitment system. Methods We conducted a web-based survey with 56 participants as well as semistructured interviews with 33 participants from 10 German university hospitals. Results We here report the recruitment procedures and challenges of 10 university hospitals. The recruitment process was influenced by diverse factors such as the ward, use of software, and the study inclusion criteria. Overall, clinical staff seemed more involved in patient identification, while the research staff focused on screening tasks. Ad hoc and planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Microsoft Office suite because tailored software were not available. To implement such software, data from disparate sources will need to be made available. We discussed concrete technical challenges concerning patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, and we contributed to the support of developing a successful system. Conclusions Identifying eligible patients is still associated with significant manual efforts. To fully make use of the high potential of IT in patient recruitment, many technical and process challenges have to be solved first. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.

Evaluation of Eligibility Criteria Relevance for the Purpose of IT-Supported Trial Recruitment: Descriptive Quantitative Analysis

“…Identifying individuals who fulfill all the EC of a study and are willing to enroll is challenging and time-consuming. In many cases, trial personnel manually search for suitable candidates in electronic health records (EHRs) [ 9 , 11 ]. A clinical trial recruitment support system (CTRSS), also called a patient recruitment system (PRS), can assist in increasing participant numbers [ 12 - 14 ].…”

“…One such criterion is the consent form that participants are required to sign during the inclusion process. Not all the EC specified in the study protocol are likely used for preselection in the context of a CTRSS [ 11 ]. When implementing a CTRSS, it is sufficient that only relevant data element groups be queried to obtain appropriate suggestions [ 30 ].…”

How can current oncological datasets be adjusted to support the automated patient recruitment in clinical trials?

“…7 For instance, the German Medical Informatics in Research and Care in University Medicine (MIRACUM) consortium 8 is developing an automated recruitment tool that utilizes patient data to determine their eligibility for clinical trials. 9 However, a significant hurdle lies in the increasing complexity of patient disease profiles, requiring more comprehensive documentation. In the field of oncology, initiatives such as the German Network for Personalized Medicine (DNPM) strive to provide personalized therapy for complex medical cases.…”

Ten Topics to Get Started in Medical Informatics Research

“…This requires high-quality data sets, seamless communication across IT systems, and standard data formats that can be processed by humans and machines [ 2 ]. Typical challenges in clinical IT implementations, especially for patient recruitment systems, were recently evaluated by Fitzer et al [ 26 ] for 10 German university hospitals, including requirements for data, infrastructure, and workflow integration. The implementation of an EHR, including an individual's medical data in a bundled form, into the CIS is a key aspect to prevent low reliability and poor user-friendliness of EHRs, which has recently been shown to affect time pressure among medical staff [ 27 ].…”