DECENTRALIZED CLINICAL TRIALS – KEY TRENDS AND STATISTICS
The DCT Marketplace
2021 WCG survey: 94% of research sites had adopted at least one decentralized methodology, while 88% of sites had hosted hybrid trials that combine remote technology and in-person site visits.
A GlobalData study found approximately 1,300 drug clinical trials with a virtual and/or decentralized component were expected to start in 2022, a 28% increase from 2021 (1,011 trials)) and a staggering 93% increase from 2020 (673 trials).
Phase III trials have been the most likely to adopt decentralized approaches like ePROS, eCOAs or eConsent, while usage of telemedicine approaches across Phase III trials increased from 2.7% in 2019 to 5.9% in 2021 – Clinical Trials Arena.
The value of the DCT market is set to increase exponentially over the decade – Valued at approximately $6.11 billion in 2020, the DCT market is projected to reach $16.29 billion in value by 2027.
Impact of COVID-19 on Decentralized Clinical Trials
The Clinical Trials Transformation Initiative survey of industry, academic and other representatives shows 85% of respondents transitioned to remote or virtual visits in one or more ongoing trials during the pandemic.
In a pre-pandemic Industry Standard Research survey, 38% of biopharmaceuticals and CROs expected DCTs to be a major part of their portfolios, while 48% expected to conduct a trial with most activities done in patients’ homes. By December 2020, McKinsey reported those responses were now 100% and 89%, respectively.
Compared to pre-pandemic times (i.e., 2017), GlobalData indicated that the DCT elements with the largest growth in usage in 2021 were eConsent (460%), web-based questionnaires (448%), oximeters (317%), emails (247%) and tablets (174%). Mentions of text messages in DCT protocols increased 130% from 2020-2021.
Adoption of Risk-Based Quality Management also increased significantly over the course of the pandemic – according to research by Stansbury et al., prior to the pandemic, 47% of ongoing 2019 clinical trials implemented at least one RBQM component; by comparison, 77% of reported 2020 clinical trials leveraged at least one RBQM components.
Medidata recently conducted a survey across Europe, asking key executives working in the clinical trials about the changes in the sector due to the pandemic and insights into the future. The pandemic increased the wider adoption of DCTs, as organizations needed to rethink their operations to fit in with the ‘new normal’. Respondents note that the average number of studies including at least one decentralized technology before the pandemic was 43%, the current average is 55% and the predicted average in five years’ time is 66%. Medidata European Industry Research Report: The Future of Clinical Trials
Time and Cost Savings
DCTs can drive savings in both time and cost – according to some estimates, DCTs may reduce trial costs by 10-25%.
Cost savings are typically derived from fewer sites, less investigator fees, lower costs for patient visits and travel costs, smaller site monitoring and management fees, etc.
DCT capabilities, namely, “bring your own device” (BYOD), enhance patient centricity and promote better patient engagement – in a survey by Byron et al., 94% of patients surveyed indicated they would “definitely or probably” use an app on their own mobile device for an upcoming clinical trial, while 45% stated BYOD would be more convenient.