Exploring the role of decentralized clinical trials in oncology: Insights from cancer centers.

Abstract

105 Background: Decentralized clinical trials (DCT) involve conducting some or all trial-related activities at a location separate from the investigator's site. DCT can help reduce the burden on patients, sites, and sponsors while improving patient accrual and retention rates and increasing the diversity of trial participants. While DCT methods provide patient-centric trial flexibilities, they can impact trial operations. This survey aimed to gain insights into the perspectives and experiences of cancer centers regarding DCT in the field of oncology. Methods: A 13-question survey that addressed prior experience, perceived benefits, and challenges in implementing DCT was developed by members of the Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) Steering Committee. The survey was sent via email to the AACI CRI listserv, which consists of members of 90 cancer research centers in North America. Respondents were asked to consider their activity related to treatment and non-treatment interventional trials. Results: There were 75 total responses from members affiliated with 55 individual cancer centers. Of these centers, 73% were NCI-designated cancer centers. Of the individual respondents, 57% were clinical trial office administrators. The issues of highest concern by respondents were 1) meeting study timelines, 2) patient recruitment and 3) cost (83%, 65%, 44% respectively). All respondents had prior experience with DCT tools with the most common components being the use of local facilities for labs/imaging, telemedicine and e-consent (89%, 69%, 68% respectively). The areas of most perceived benefit from DCT include reduced participant burden, increased diversity and participant retention (81%, 80%, 68% respectively) while areas of perceived challenges include quality control, regulatory compliance and cost (61%, 59%, 49% respectively). While 92% respondents agreed/strongly agreed that DCT can improve clinical trial access, 92% agreed/strongly agreed that additional site staff training is required for successful DCT implementation. Conclusions: DCT tools have been widely implemented in oncology trials with all surveyed sites reporting prior experience. This survey emphasizes the perceived benefits of DCT in oncology, while underscoring the importance of addressing challenges and meeting the specific requirements of cancer centers. Future work should identify specific areas that require additional staff training to enable DCT readiness.