Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study.

Abstract

Industry stakeholders, academic experts, and regulatory bodies emphasize the importance of prioritizing a patient-centered experience in clinical trials to enhance retention, adherence, and trial participation. Concurrently, there has been a notable rise in the adoption of technology-mediated decentralized methodologies for conducting clinical trials. Nonetheless, is a truly patient-centric approach being achieved? The shift to decentralized approaches risks prioritizing operational efficiency and remote data collection over the nuanced and diverse needs of participants. This raises critical questions about whether the current implementation of decentralized clinical trials (DCTs) fully aligns with the principles of patient centeredness. Using a qualitative approach, our study aims to understand the perceptions of clinical research staff (CRS) of this transition and its impact on delivering a patient-centered experience. A total of 15 CRS with experience of facilitating DCTs were interviewed, and transcripts were analyzed. Our findings reveal 1 superordinate theme-the quality and frequency of interactions with patients and CRS are limited-and six main themes: (1) increasing demands of the CRS role, (2) creating difficulties for patients, (3) knowing the patient and understanding their experience, (4) impacts on forming and maintaining CRS-patient relationship, (5) difficulty in delivering desired level of support and care, and (6) perceived affects to conduct of a trial. While DCTs offer advantages in improving accessibility, they introduce new complexities that can negatively impact patient engagement, retention, and the CRS-patient relationship. This study offers insights into the perspectives of CRS on delivering a patient-centered experience in DCTs. It highlights the benefits of DCTs alongside the challenges they present, emphasizing the need for additional support, training, streamlined technology, and resources to help CRS adapt to evolving trial dynamics. To fully realize the patient-centered potential of DCTs, technology and trial designers must recognize the complex interplay of factors shaping the patient experience. This requires collaboration with CRS and patients to address the diverse needs of all stakeholders, prioritizing the broader aspects of the patient experience beyond at-home convenience and data collection.