Creating Success With Digital Measures

By Musaddiq Khan, VP, Customer Value, Digital Outcomes and TA Strategy

The landscape of clinical trials is undergoing a significant shift with the increasing prevalence of digital measures and digital health technologies (DHTs). Wearable devices have been steadily gaining traction in clinical trials since 2014, with approximately 2% of trials utilizing them as of December 2023. This growth is driven by the demand for decentralized clinical trials (DCTs) and supportive regulatory guidelines.

Digital measures, such as sensors, wearables, and electronic patient-reported outcomes (ePROs), offer numerous advantages in clinical trials. They provide real-time monitoring, allowing for early intervention and improved adherence monitoring. They also enhance the understanding of diseases and reduce participant burden. Recent research has shown that digital measures have a significant return on investment (ROI) in clinical trials. Phase 2 trials have seen an increase in earned net present value (eNPV) and ROI, while Phase 3 trials have experienced even higher eNPV and ROI. Additionally, digital measures have been associated with shorter trial durations and smaller sample sizes.

However, it is crucial to focus on selecting the right digital measures to avoid overwhelming participants and ensure valuable insights are gathered. Unified platforms and frameworks are needed to integrate data from multiple systems and standardize analysis.

The future of clinical research is expected to be digital, with partnerships between technology providers and device manufacturers driving innovation. Embracing digital measures and partnering with experienced providers like Medable is becoming a necessity for sponsors and contract research organizations (CROs) to stay at the forefront of this revolution and improve patient outcomes.