In an interview with Applied Clinical Trials Associate Editor Don Tracy, Samuel Salvaggio, Senior Trial Design Lead, One2Treat, discusses the company's main goals for attending the SCOPE Summit, including patient centric trial design.
ACT: What are your primary objectives for attending SCOPE 2025, and what insights are you hoping to gain regarding trial design innovations?
Salvaggio: Like most people coming to SCOPE, we came here to see what's driving innovations in clinical trials and operations. At SCOPE, you have hundreds of companies, vendors, and clinical startups like us, and they all present in different tracks that are of interest to us. Specifically, I’m most interested in the patient centric trial design track.
ACT: Are there any specific trends in trial design, such as decentralized trials, real-world data integration, or AI-driven protocols that you anticipate being major discussion points?
Salvaggio: Those are all very interesting tracks that are well presented here. But as I mentioned, I'm more interested in patient centric trial design and what it entails. While those methods are used in patient centric trial design, they are not the only one that are being used. The FDA recently promoted regulations and guidance on how to include patients in clinical trial development, but they don't really say how to do it. That’s why we come to these kinds of conferences, to promote new, concrete ways on how can you include patient voices into clinical trial design and strategy.
Full Interview Summary: One2Treat s attending SCOPE to explore innovations in clinical trial operations, with a strong focus on patient-centric trial design. They highlight the event’s diverse range of participants, including companies, vendors, startups, and sponsors, all contributing to discussions on trial advancements.
While decentralized trials, real-world data integration, and AI-driven protocols are major industry trends, the speaker is primarily interested in how patient voices can be effectively integrated into trial design. They note that while the FDA has recently issued guidance on patient inclusion, it lacks detailed implementation strategies. Conferences like SCOPE provide a platform to discuss concrete methods for incorporating patient perspectives into trial strategies.
Regarding partnerships, Salvaggio emphasizes the importance of collaboration with site investigators and patient representatives. These stakeholders play a crucial role in ensuring that trials are designed with patient needs and experiences in mind, ultimately improving trial success and patient engagement.
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