by: Dr. Michelle Longmire, MD, CEO and Colin Weller, GM Digital Endpoints and Measures

As we look ahead to 2024, the landscape of clinical development is poised for significant advancements in digital and artificial intelligence. As leaders in clinical outcome measurement and innovation, our team at Medable is mission driven to continue to accelerate clinical development timelines with transformation technology. 

Digital Biomarkers

The coming year is expected to see a surge in the development of digital biomarkers in clinical trials. This will enable greater collection of real-time, accurate health data through wearable devices, mobile apps, and remote monitoring tools. This development promises more precise and sensitive empiric measures of clinical outcomes, providing deeper insights and reducing the number of participants required in trials. 

Expanding Patient Access in Trials

Decentralized endpoint strategies will continue to be incorporated into trial designs for endpoints suitable for remote or sensor based collection. Given this and an increasing number of validated outcomes that can be measured by wearables, digital tools will play a crucial role in breaking down geographical and logistical barriers, offering broader access flexibility for patients in clinical trials. This continued evolution will enable the inclusion of patients from remote or underserved areas, diversifying trial participation and enriching the data with more true-to-life patient experiences.

Enhancing Clinical Outcome Measurement

Clinical development will increasingly leverage digital technologies to track a wider range of outcome measures, including both physiological and behavioral indicators; given mounting pressure to measure the impact of interventions on the entirety of patient health in the Inflation Reduction Act. This comprehensive approach will empower clinicians, researchers and regulators to make more informed decisions, enhancing treatment efficacy and paving the way for personalized therapeutic strategies.

Pioneering Precision Medicine

The rich datasets derived from digital biomarkers will be key in advancing precision medicine within clinical development. Analyzing these data patterns will allow clinicians to predict health outcomes more accurately, leading to proactive disease management and tailored treatment protocols.  By combining objective and subjective data directly collected from patients at source and in real time, precision measures offer the opportunity to utilize progressive, novel trial designs with highly relevant, specific, and meaningful endpoints.

Artificial Intelligence for Next Generation Clinical Measures and Trial Insights

AI and machine learning provide critical advancements in digital biomarkers and data analytics. Now we can develop more sensitive and specific digital biomarkers, combining a range of data types from patient reported, clinically obtained, and sensor-based. Improving the sensitivity and specificity of endpoints reduces the number of participants required for clinical trials, therefore reducing the timelines and cost of clinical development.

Seizing the Digital Opportunity

2024 is about actively leveraging artificial intelligence and digital to drive drug development forward. By embracing these technologies, can accelerate clinical development timelines, enhance patient care, and improve health outcomes.