The evolution of an oncology site network partnership in a COVID era clinical trial environment.

Sarah MacKay Helou, Tanya Vidhyarkorn,Sarah Churchill,Janice Russell

JCO global oncology(2023)

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摘要
125 Background: As a leader in cancer therapy research, Roche created the immunotherapy Centers of Research Excellence (imCORE) Network, a worldwide research network designed to connect members in an open environment of shared information, expertise, and decisions. This network is dedicated to advancing the comprehension of the underlying science and shared operational challenges in order to accelerate the most promising new treatment options for patients. Pre-pandemic the imCORE network was an established partnership model leader with several years of experience. Relationships between site and sponsor were established and consistent. Regularly cadenced face to face and virtual meetings provided proven pathways for open communication and collaboration opportunities. A pipeline of operational efficiencies, pain point interventions, best practices and strategies were brainstormed, co-created, and implemented across multiple workstreams. COVID arrived in March of 2020 and over the course of the next months to years the world changed. These changes were felt acutely, directly impacted clinical research, and specifically impacted imCORE sites, their patients, the network, and how it operates. Methods: This paper focuses on the Roche Sponsored clinical trial operational excellence aspects of the network. Data is collected from network sites related to pre and "post" COVID priorities and impacts. The data is then analyzed to produce best practice recommendations for oncology research sites and networks. Results: It highlights the direct impacts of COVID to a sponsored trial site network. This includes specific measures the network has taken to evolve to fit the needs of its sites and their patients and presents a pathway forward for site networks to consider in the new reality of COVID era clinical trials. Conclusions: COVID impacted and continues to impact clinical research sites and sponsored trial networks in significant and lasting ways. Site and network operations need to evolve to meet the needs of patients and staff in this new reality.
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关键词
oncology site network partnership,clinical trial environment,clinical trial,covid
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