March 20, 2018

Use and adoption of site-facing technology

The Pulse on Technology by Elisa Cascade

EDC, RBM, SSO, etc.—These three-letter acronyms related to technology are enough to make your head spin. Everyone’s talking about the latest site-facing technology and how it could improve clinical trial operations efficiency, but I thought I would start off the new year (and the new Pulse on Technology column) by setting the record straight on current technology usage by global sites. This will also set us up for future deep-dives into individual clinical trial technologies!

From June to August 2016, DrugDev completed a survey of 418 investigators across eight countries: Argentina, Australia, Brazil, Germany, India, South Africa, the U.K. and the U.S. Within this survey, we asked a series of questions related to use and adoption of the following site-facing technologies:

  • eConsent: Electronic patient informed consent for the clinical trial on any device
  • Electronic Data Capture (EDC): Capture of clinical trial data in electronic format
  • Electronic Trial Application: Tools to optimize workflow processes, site engagement and training from startup through closeout
  • eSignature: Digital signature on all clinical trial documents
  • eSource: Creating trial data source records electronically based on EMR/EHR data
  • Paperless Trials: 100% electronic document storage
  • Patient Retention: Text, email and other communications to remind patients about visits and encourage them to stay in a study
  • Patient Stipend: Patient compensation for time and/or travel
  • Risk-Based Monitoring (RBM): Tailoring of the frequency and type (on-site, remote) of monitoring activities to risk assessed based on data analytics
  • Single Sign-On (SSO): One login password to access all applications used for the clinical trial

A definition was provided to the respondents to eliminate any chance of confusion in interpretation of the technology function.

Results from the global site survey suggest that over 70% of global investigators have experience in using four technologies: EDC, electronic trial applications, eSignature and RBM. Although some use of these site-facing technologies is high, EDC is the closest to a “gold standard” technology, with 52% of sites reporting use of EDC on all studies and 93% of sites having at least some experience with the technology. eSignature was reported to be used on all studies by 25% of global investigators, and 77% of sites reported usage of eSignatures on at least one study.

Finally, 17% of global sites reported use of an electronic trial application across all trials, with 78% of sites having some experience of electronic trial applications. Adoption of the other technologies across all studies was at 6% or less for surveyed sites, and trial on at least one study was ~50% or less with the exception of RBM—72% of all global sites had some experience of RBM, but only 3% of sites were using RBM on all of their studies. This finding, combined with data from another question related to whether the technology has a positive vs. neutral vs. negative impact on clinical operations, suggests that site perception of the value of RBM will need to be addressed before the technology is adopted across all studies.

There was some variation in technology adoption related to country, with the highest EDC use on all studies in Argentina (69%), South Africa (68%) and the U.S. (65%), and the lowest in India (35%), Australia (34%) and the U.K. (33%). The variation in 100% technology adoption across countries was lower for eSignature (from 38% in South Africa to 7% in India) and electronic trial applications (from 29% in Australia to 10% in the U.K.).

These findings suggest that while many clinical trial sponsors have piloted the use of various site-facing technologies, only EDC has moved to a state of adoption by a majority of investigator sites. However, at the country level, there is still some work to do before the majority of sites within each country have adopted EDC. Conversations with study sponsors suggest that universal adoption of site-facing technologies will accelerate in 2017. DrugDev plans to repeat its annual investigator survey and I hope to have an update for the Pulse on Technology column later in the year.