Fortrea is thrilled to support as Premier Sponsors of the SCOPE-Europe 2024 Summit! Our team of trial experts will be onsite and ready to connect with you. Stop by booth 39 to learn more about Fortrea’s 30+ year heritage of CRO experience and how we can help you navigate the best path to get life-changing solutions to patients, faster.
Track: C1: Trial Design and Protocol Development
Assumptions are the root of all mistakes: Designing engaging studies whilst avoiding the ‘unicorn’ protocol design
Assumptions in clinical trial design can directly impact patient recruitment, start-up timelines, and ultimately study outcomes. While there has been some headway through a more patient-centric design philosophy, it is ultimately sites who take the protocol and execute it with patients. Sites bring a long-earned wealth of experience and, if permitted, ideas about how protocols might be designed to enhance their viability. Listening to and incorporating input from sites and patients concurrently drives studies that bring new treatments to the right patients, faster. This site-centric / patient-centric approach is a potent model for achieving efficient studies that satisfy the demands of sponsors and patients. In this session, we look at measures that can be taken to go beyond simply listening, and design-in intelligent and compassionate protocol measures that leverage the wisdom of sites and respect the realities of patient-participants.