SPEAKERS

Selecting the appropriate sites for a clinical study is one of the basic criteria for a successful study. This is the engine for a quick and correct patient recruitment which will influence the length of the recruitment phase hence the total duration of the study. On another aspect, the correct selection of sites will result in better patients training and better clinical data collection- by that increasing the probability of the study to be a success.

• Operation Criteria for Site Selection
• Clinical Criteria for site Selection
• CRO Input vs. Sponsor needs
• Quicker patients ´recruitment
• Better Clinical Data

In the UK we are in a unique position with respect to having a “free of charge” support to help identify and manage the performance of NHS clinical trial sites involved in commercial (and academic) research, yet in many cases this valuable resource is under-utilized.

• UK network Clinical Trial Offerings
• Guide to commercial Sponsor Engagement
• Outcomes- successes and frustrations
• Case for continued collaboration and future opportunities

Many sponsors nowadays focus on engaging with patients in order to optimize the clinical research experience for study participants. This session will focus on the Patient Voice: what is it, different types and methodologies, how do you organize in the heath of study start-up, and how do you measure success?

• Patient Voice purposes
• Patient Voice methods
• Patient Voice on the critical path in study design
• Measurement framework
• Return on engagement

• Rare diseases and oncology introduction and patient definition
• Challenges in early phase rare disease
• Comparing the enrolment strategies in rare disease
• Exceptional approach in rare disease in clinical studies
• Possible future of development rare disease