Decentralized Clinical Trials: The Future of Clinical Research Is Here
By Medidata
Improvements in technologies and methods to drive clinical trial innovations have focused on the incorporation of decentralised clinical trials (DCTs) - also sometimes referred to as ‘remote’, ‘hybrid’, ‘virtual’ or ‘patient-centric’ trials.
The COVID-19 pandemic has significantly accelerated the adoption of DCTs, which allowed sponsors to quickly virtualise many trial activities, including remote monitoring, telehealth visits, electronic consent (eConsent), electronic patient reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), and use of wearables/sensors. The uptake in DCTs is expected to continue in a post-COVID-19 world due to the experience gained during the pandemic
The DCT trend is being driven by several headwinds that have converged, including the COVID-19 pandemic, ballooning drug development costs, and a greater focus on the patient-centricity and value demonstration of new therapies.
Clinical trials are currently evolving and becoming modernised as they continue to integrate more and more virtual elements. Sponsors must prepare themselves for this increasingly digital future, which will demand scalable, flexible, interoperable, unified, and intelligent software platforms to synthesise patient-centric data into real-time insights that will offer benefits to stakeholders across the healthcare spectrum.
This white paper provides an introduction to DCTs and summarises the state of the industry from the perspective of different stakeholders, including the pharmaceutical and medical device industries, regulators across the world, and patients.
Download this white paper today.