ICON plc has unveiled a comprehensive Outcome Measures solution designed to transform clinical trial design and execution through enhanced patient-centricity. The new offering, launched in September 2024, provides pharmaceutical sponsors with end-to-end support for implementing evidence-based measures that capture meaningful patient outcomes throughout the drug development process.
Revolutionizing Clinical Trial Design with Patient-Centered Outcomes
"Every patient, every disease is different," explains Sonia Bothorel, Managing Director of Mapi Research Trust and Outcome Measures Solutions. "Therefore, it is important to ask patients what matters to them, quantifying side effects versus efficacy, to have this holistic view of the impact of the treatment."
The solution integrates traditional clinical outcome assessments (COAs) with cutting-edge digital health technologies (DHTs), enabling sponsors to collect more comprehensive patient data. This dual approach provides deeper insights into how treatments affect patients' daily lives beyond conventional clinical endpoints.
Digital Innovation in Patient Monitoring
The integration of digital health technologies has significantly enhanced researchers' ability to gather real-world patient data. Bothorel highlights practical applications: "In sleep disorder trials, wearable actigraphy devices provide objective measures of sleep patterns, tracking movement traits and wake time, offering a more comprehensive picture than traditional sleep diaries alone."
Similarly, in Duchenne disease studies, DHTs complement the traditional six-minute walk test (6MWT) by providing additional gait analysis data, demonstrating how technology can enhance traditional clinical assessments.
Comprehensive Service Portfolio
ICON's Outcome Measures solution encompasses:
- Strategic advisory services for COA implementation
- Access to the ePROVIDE platform and Atlas for DHTs
- COA licensing and distribution through Mapi Research Trust
- eCOA implementation services
- Translation and linguistic validation support
"The most important thing to keep in mind here is that there is an increasing trend regarding including patient-centric assessment in clinical trials and even more so in healthcare delivery," notes Bothorel.
Regulatory Alignment and Future Impact
The solution aligns with evolving regulatory requirements, including the FDA's Patient-Focused Drug Development (PFDD) initiative and similar EMA guidance. This alignment can potentially accelerate the approval process while ensuring that drug development truly addresses patient needs.
With approximately 42,250 employees across 106 locations in 55 countries, ICON is well-positioned to implement this solution globally, marking a significant step forward in the evolution of patient-centered clinical research.
