Accelerate Clinical Development With Patient-Centered Digital Endpoints

By Christine Guo, PhD, Chief Scientific Officer, ActiGraph

Drug development success rates have been on the decline since 2015. Compounded by the pandemic, trial success rates fell to a 10-year low in 2021, averaging only a 5% likelihood of successful progression through all phases.¹ The machinery of clinical development urgently needs some new oil. One of the most challenging and costliest steps in clinical development is to demonstrate clinical efficacy based on the clinical outcome assessments (COAs) collected during clinical trials. Most of these COAs were developed decades ago, and they have changed very little since then. Despite known limitations in measurement precision, clinical trialists continue to rely on these traditional COAs for R&D decision making, regulatory approvals, and market access. While biomarkers have improved trial efficiency in some cases, patient-centered clinical outcome assessments remain essential – the lack of which can lead to commercial catastrophe, as witnessed in the recent controversy surrounding Biogen’s Aduhelm.²