AstraZeneca is transforming clinical trial execution through its innovative Unify platform, combining precision medicine approaches with digital technology to enhance patient participation and data collection efficiency.
Precision Medicine Driving Patient Selection
"Attrition in drug development for chronic disease is high, often because the wrong patients are selected for clinical trials," explains Ben Challis, VP and head of translational science and experimental medicine at AstraZeneca. The company's precision medicine initiative aims to select patients based on their underlying disease biology and drug mechanism of action, addressing this critical challenge in drug development.
Challis emphasizes that chronic diseases' heterogeneous nature requires careful stratification through molecular biomarkers, which has become a key focus of AstraZeneca's research efforts.
Digital Innovation Enabling Decentralized Trials
The Unify platform, operational since December 2020, has achieved significant scale, now functioning in more than 28 countries and supporting 62 languages. The platform facilitates 'frictionless trial experiences' through decentralized approaches, addressing geographical barriers and accessibility challenges for patients with severe conditions.
Magnus Jörnten-Karlsson, executive director of Unify, highlights the shift toward improved home testing: "Clinical trials are currently moving away from 100% reliance on clinical labs, and towards improved home testing." The platform's long-term vision encompasses continuous monitoring of patients' vital signs and general health to enable early disease detection.
Reducing Patient Burden and Improving Retention
Current statistics show approximately 15% patient drop-out rates in clinical trials, primarily due to lifestyle burden and medical complications. The Unify platform addresses these challenges by providing comprehensive support, including:
- Transportation assistance and childcare during trial visits
- Detailed visit preparation information
- Telehealth capabilities
- Direct-to-patient supply
- Medication reminders
- Remote data collection through connected devices
Innovation in Data Collection and Monitoring
A notable advancement includes the clinical validation of remote-coached spirometry within COPD studies, allowing healthcare professionals to conduct lung function tests and PEF readings through virtual patient visits. The platform displays real-time data in the HCP Unify web portal, enabling immediate result verification during virtual consultations.
Future Developments
The platform's 2023 development roadmap includes several major functionality upgrades:
- eConsent implementation for streamlined patient enrollment
- ECG measurement capabilities
- Vital signs monitoring
- Home testing for kidney disease via connected devices
These innovations aim to address the current low clinical trial participation rates, which stand at only 3-5% of eligible individuals, by making trial participation more accessible and patient-friendly.
