The Research Visit of the Future: an academic-industry model for telehealth, electronic clinical outcomes assessments, and Decentralized Clinical Trials (DCTs)

Abstract

The COVID pandemic initially led to the unprecedented suspension of large numbers of clinical research studies and trials that required in-person study visits, highlighting the need to reevaluate how human participant research projects are conducted. During this time the University of Pittsburgh Clinical and Translational Science Institute (Pitt CTSI) embarked on a multi-year initiative to envision the Research Visit of the Future, which ultimately led to an academia-industry partnership that enables the scalable self-service model using a virtual clinical research platform for clinical studies at a major academic research institution. This model enables the flexible deployment of eConsent, Telehealth (audio/video) calls, synchronous and asynchronous data capture, integrated sensors and wearables, and patient engagement tools, all within a single participant-focused research platform. Academic investigators can configure their studies without custom coding across a wide range of study designs, including hybrid- and fully decentralized clinical trials. Here we present the journey to identifying the technology requirements to enrich data collection, structure of our partnership model, and considerations for crossing the digital divide to enable broader access to clinical research among diverse and under-represented communities.

Keywords: Decentralized clinical trials; Digital divide; Diversity; Inclusion; Telehealth.