At the 2024 Research Revolution, one of the standout sessions was CTTI’s Frameworks for Innovation. It brought together thought leaders in the clinical trials industry to discuss strategies for transforming trials into more patient-centered, efficient, and impactful endeavors. As we begin 2025, with visions of the future on our minds, the insights from that session become ever-more impactful. In their presentation, CTTI shed light on two major initiatives: the Measuring Trials Transformation Framework (MTT) by the Clinical Trials Transformation Initiative (CTTI) and the ISF Reference Model by CDISC.
Reimagining Clinical Trials by 2030
CTTI has laid out a bold vision for the future of clinical trials, built on five transformative pillars:
- Patient-Centricity
Placing patients at the heart of clinical trials by making participation more seamless and accessible.
- Integration into Healthcare
Embedding trials into standard healthcare workflows to reduce friction and improve efficiency.
- Quality-Driven Design
Ensuring trials are conceived and executed with a relentless focus on quality.
- Data Leverage
Utilizing both clinical and non-clinical data to drive smarter, more insightful trials.
- Advancing Public Health
Aligning trial outcomes with broader public health goals for maximum societal impact.
Measuring Progress: The MTT Framework
CTTI’s MTT framework tracks progress using 19 domains and 57 measurable metrics. Each domain aligns with a pillar, providing a structured way to measure success and set future goals. For instance, one domain under patient-centricity measures the percentage of trials offering remote participation options.
Standardization: A Path to Simplicity and Efficiency
CDISC’s ISF Reference Model addresses inconsistencies in how sites manage investigator site files (ISFs). This initiative promises to simplify document management, streamline audits, and improve compliance by providing a standard structure for ISFs.
The benefits include:
- Reduced Errors: Standardized naming and filing practices eliminate confusion.
- Seamless Integration: Alignment with the TMF (Trial Master File) ensures smooth transitions.
- Improved Audit Readiness: Predictable filing systems simplify regulatory reviews.
The Road Ahead
Both CTTI and CDISC emphasize collaboration, transparency, and data-sharing as essential tools for navigating the exponential growth in clinical trial data. These initiatives are setting the stage for a more unified, effective, and patient-centered future.
