Evidence & Insights: A Data-Driven Exploration Of Decentralized Elements And Digital Trial Technologies

The landscape of clinical product development is undergoing rapid transformation. While technological advancements are not unfamiliar to society, their accelerating pace is unprecedented. According to Business Insider, "It took 30 years for electricity to reach 10% adoption among US consumers, whereas the telephone achieved the same in 25 years. Tablets accomplished this in just five years—despite not being our primary devices."

In the post-COVID era, the technologies and processes adopted to maintain clinical trials quickly became the new norm. Over just four years, clinical research witnessed a rapid shift toward digitization and decentralization. Innovations such as remote data capture via mobile devices and wearable sensors, virtual visits, and remote monitoring have fundamentally reshaped the research landscape.

Simultaneously, the ascendance of artificial intelligence (AI), machine learning (ML), and automation reached a crescendo in 2023 with the introduction of generative AI. These technologies are heralding a new era in clinical research, unlocking unprecedented insights and capabilities. Analysts predict substantial growth, with electronic outcome assessments (eCOA) projected to reach $4.7 billion by 2030. AI and ML are anticipated to revolutionize women's health, oncology, rare diseases, and other fields within the life sciences industry.

Yet, progress requires more than mere promise. In recent years, Medable, in collaboration with esteemed academic institutions like Tufts University's Center for the Study of Drug Development (CSDD), Duke University's BASE Lab, and Harvard's Multi-Regional Clinical Trials (MRCT) Center, has demonstrated the tangible impact and value of digital technologies. Concurrently, regulatory bodies such as the FDA and EMA are issuing draft guidance and recommendations to navigate this transformative landscape.

Despite these advancements, approvals are reported to be slower than ever. To address the remaining 10,000 human diseases within our lifetime, we must accelerate the pace of research significantly.

In light of these developments, we showcase how Medable and industry peers are driving change, accelerating the delivery of effective treatments to patients.