Teletrials, the new norm? Expert recommendations for teletrials into the future: Findings from the Clinical Oncology Society of Australia Clinical Trial Research Professionals Group Workshop

Abstract

Introduction The Australasian Teletrial Model was piloted in co‐funded sites across Australia. The purpose was to extend the reach of clinical trials using telemedicine to improve equity and access to this treatment pathway for oncology patients. Experts across Australia gathered to share the learnings of implementation so that future directions can be effective and sustainable. Methods The 1‐day workshop was attended in person and virtually. Attendees were invited to analyze and disseminate the results. Recordings from the presentations were coded independently by three researchers and synthesized. The results were sent to the authorship team for further review to build consensus on the findings in three drafts. Results Four key themes were identified: “Being on the Same Page,” “Building Foundations,” “Key Roles in Teletrials,” and “Incentives.” Although there were many successes that were accelerated by the COVID‐19 pandemic, there is work still to be done. Conclusion The Australasian Teletrial Model has been identified as acceptable and feasible. Future directions need to continue to work on streamlining regulatory processes, implementation and monitoring, and build knowledge to further build networks across Australia.

Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review

“…The description of CRN involvement in DCT conduct and reporting of clinical trial data comprised three different domains: network facilitation, protocol procedures and research-based care availability. The CRN role was found to be instrumental in creating relationships with participants, communities and healthcare facilities to support optimal decentralised trial function (Roberts et al, 2022: 1–10). Networking was used to troubleshoot operation-based concerns, such as equipment storage constraints and ensuring the correct physical environments were available within the community for blood draws, assessments and data collection (Coyle et al, 2022: 1031–1042; National Academies of Science, Engineering, and Medicine et al (2019); Stansbury et al, 2022: 415–422).…”

“…This includes the consideration of healthcare professional licensures and scope of practice, which may vary between states and countries (Fowler et al, 2021: 1–11). Geographical distance and under-resourced communities will affect staff availability, prompting trial sponsors to budget additional funds to leverage home health nursing or other professionals to support trial visit completion either in-person or via telehealth (Hawking, 2021; Roberts et al, 2022). The participant experience is also affected, as some feedback has included missing in-person interaction if more virtual components are used in the DCT model (Fowler et al, 2021).…”

Telehealth adoption in cancer clinical trials: An Australian perspective

“…Similar recommendations were echoed by the Clinical Oncology Society of Australia Clinical Trial Research Professionals Group 52 who found "being on the same page" was a key element to success of tele-trial implementation and aided by: having clear written guidelines; a united vision; and more streamlined ethics and governance processes. 52 While they reported successful examples of The Australasian Tele-Trial Model in action, areas for future improvement included having the model as routine care rather than a novelty, and diversifying income sources to reduce the reliance on pharmaceutical sponsors. 52 The primary strength of this current study was the strong representation of cancer clinical trials groups across Australia, which captured a broad range of viewpoints from clinicians, researchers, trial administrators, trial coordinators, and managers.…”

“…52 While they reported successful examples of The Australasian Tele-Trial Model in action, areas for future improvement included having the model as routine care rather than a novelty, and diversifying income sources to reduce the reliance on pharmaceutical sponsors. 52 The primary strength of this current study was the strong representation of cancer clinical trials groups across Australia, which captured a broad range of viewpoints from clinicians, researchers, trial administrators, trial coordinators, and managers. The focus of this investigation was CTGs operating within Australia and the Australian health care system.…”

“…While the uptake of tele‐trials has gradually increased over the past few years, traditional in‐person care remains the dominant approach. Albeit, to further sustain tele‐trial conduction, both national and state governments have developed standard operating procedures for tele‐trials 9,10 . Indeed, there is also a renewed government interest supported by larger research funding schemes, including the Medical Research Future Fund (MRFF) to provide more Australians with access to clinical trials 11…”