Decentralized elements within oncology trials: Labcorp experience.

Abstract

e13630 Background: The concept of digital health using Decentralized elements (DE) has rapidly gained acceptance due to the COVID-19 pandemic, moving clinical trials (CTs) to a more patient-centric model (PCM) with fewer site visits. The primary aims of DE are reducing patient burden, increasing enrolment and retention, maintaining quality of life, and decreasing overall trial cost. Methods: Between 2011 and 2022, Labcorp conducted 491 CTs which incorporated DE: telemedicine, electronic clinical outcome assessments (eCOA), electronic informed consent (eConsent) and mobile clinical services (MCS). All CTs were analyzed by therapeutic area, study phase (1-4) and country. Results: The COVID-19 pandemic increased the implementation of DE. However, digital health uptake between therapeutic area differed. Comparing Oncology with Neurology (higher increase in research), whilst eCOA was implemented most in Oncology, the Neurology MCS increase was over 50% since 2020. Overall, Big Pharma implemented ~1.5% more Decentralized elements, vs the biotech sector. The majority were phase 3, followed by phase 2, with MCS increasing its demand in phase 1. By country, USA, Spain, France, Germany and Canada dominated. The majority were hybrid CTs, with few completely virtual. Conclusions: Labcorp experience demonstrates that overall, the interest to implement DE in CTs continues to grow, promoting the transition to a PCM. Nevertheless, solutions like MCS still need to gain more acceptance in Oncology due to the added complexity and logistics and will require training of all stakeholders, as well as understanding the benefits and potential country-specific limitations. [Table: see text]