ICH E6(R3): How industry & regulators are making the transition to Risk-Based Clinical Trial Management

Download the new Tufts CSDD White Paper for themes and insights from roundtable discussions between industry executives and representatives from global regulatory agencies.

The final ICH E6 R3 guidelines are encouraging clinical research stakeholders to move away from checklist-driven compliance toward risk-based, fit-for-purpose processes that leverage proportional risk, digital technologies, and site and participant-centric practices.  This white paper from the Tufts Center for the Study of Drug Development (CSDD) — developed in collaboration with CluePoints — summarizes the outcomes of two in-depth roundtable discussions between senior R&D leaders and regulators from FDA, EMA, and MHRA.  

Specifically, the white paper examines how organizations are approaching and navigating the transition, and the challenges they are encountering/expect to encounter.  Key themes and insights include:

• Embedding proportionality and QbD from the outset 
  See how Sponsors are moving away from rigid protocols and instead designing studies that focus on what is critical to quality, feasibility, and participant safety.
  
• Strengthening accountability and collaboration across functions
  Understand how ICH E6(R3) clarifies responsibilities for Sponsors, CROs, investigators, and vendors,  ensuring accountability aligns with operational control.
• Building training and capabilities needed to adopt R3
  Explore how global training initiatives, regulatory guidance, and internal upskilling efforts are preparing organizations for consistent, modern interpretation of the guideline.
• Closing infrastructure and technology gaps
  Learn what’s needed to transition from legacy, paper-heavy workflows to integrated platforms that support centralized monitoring, data governance, and real-time oversight.
• Accelerating cultural change for sustainable RBQM maturity
  Discover why shifting mindsets, toward transparency, critical thinking, and cross-functional integration, is as important as updating systems and processes.

Download the white paper today.