Quantifying Patient Burden in Protocol Design to Reduce Complexity and Drive Patient-Centricity

Description: Sponsors aim to design and execute clinical trials that balance participant safety, treatment efficacy and operational feasibility. In practice, increasingly complex trial designs result in high patient burden and slow enrollment, cost overruns and delayed commercialization.

To mitigate the potentially negative impacts of protocol complexity and deliver on the commitment to patient-centricity, sponsors have increasingly focused on developing automated patient burden assessments in prospective protocols that leverage robust patient burden quantification framework, AI models and rich protocol design, operations and RWE data.

In this talk, we will present our multidimensional patient burden framework based on primary research (patient focus groups and surveys), clinician and site personnel feedback and share the results of framework validation against operational outcomes. In addition, we will discuss how sponsors have adopted this framework to identify, quantify and mitigate the sources of patient burden in clinical trials across TAs.

Participants in the session will be able to:
- Describe major components of protocol complexity, including patient burden
- Understand the drivers of patient burden
- Delineate major data sources (e.g., protocol design, operational and RWE data) that are needed when quantifying the impact of protocol design on patient burden
- Understand how a robust patient burden framework can be embedded in existing protocol design and review processes to drive protocol complexity reduction and improve patient experience in clinical trials