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Vive le Mobile Revolution! But are clinical trial sites ready?

Wednesday, July 5, 2017

The Pulse on Technology by Elisa Cascade

In the past, the pharmaceutical industry has been reluctant to jettison old-fashioned methods in favor of new technologies. This has bolstered the industry’s critics, who argue that the old methods are to blame for the growing costs and timeframes of clinical development. However, this has begun to change over the past five years due to several factors, including regulatory authorities’ willingness to consider new approaches to clinical trial operations. As a result, technology is now being introduced into the industry at a rapid rate, with a high degree of trial use, but lower overall adoption1.

While some solutions, such as EDC, electronic trial applications and payment portals, are accessed through desktop or laptop computers, newer patient-facing technologies are designed for mobile and tablet devices. In addition, patients are more mobile-friendly than ever, with over half of the world’s web traffic coming from a mobile phone2. However, data shows sites may not be ready to embrace the mobile technology revolution.

This column explores a fundamental question: Do sites around the world have the basic technology in place to take part in the mobile revolution?

We asked 572 clinical trial investigators in nine countries a series of questions regarding access to technology in our annual DrugDev Investigator Survey in 2015. Eighty percent of respondents reported that all of their staff had access to a computer for clinical data collection (range: 66% in India to 89% in Australia). The primary type of device available at the site for clinical data collection was a desktop computer (85%), and the next most commonly available device was a PC-compatible laptop (38%). Tablet and mobile devices were much less commonly available (Apple tablet/mobile in 12% of cases and android tablet/mobile in 11%).

This picture of site computing hardware being largely desktop computer-based is backed up by usage data for DrugDev’s freely available online profiles system. Over the last year, 90% of users accessed their online DrugDev profile via a desktop or laptop computer, 9% accessed through a mobile device and 2% via a tablet. Access statistics for the broader DrugDev Spark suite of clinical operations modules are similar with 98.8% using a desktop or laptop, 0.9% a mobile device and 0.3% a tablet.

With the reliance on desktop and laptop computers at sites, what happens with technologies specifically designed to be used via a tablet device, such as eConsent? In these instances, organizations must either provide devices to sites, or partner with another technology provider (e.g., ePRO).

We’re curious to learn what sites think about vendors adding more and more hardware to their existing arsenals. We have heard nightmarish stories of cabinets and drawers filled with tablets, with the staff having to label them—this one’s for trial X, this one’s for trial Y, this one’s for trial Z. They’ve got to keep them all charged and remember the passcodes for each device. As an industry, we must acknowledge that it is wasteful and burdensome for the sites to store all of this technology that is qualified for use on just a single study.

All those devices threaten to bury sites as more clinical trial innovations, particularly for consenting and data capture, are made available. The future depends on increased reuse—clinical trial applications that run on any qualified tablet, so sites have fewer tablets with more capabilities.

So, to go back to the original question—are sites ready for the revolution? Unfortunately for 2017, the Magic 8 Ball would say, “Outlook not so good.”  Widespread adoption of mobile technology will be challenging (and expensive) to realize until the time that device interoperability can be achieved. Only then will sites be truly freed by the mobile technology revolution to concentrate on clinical research activities, rather than on the devices they are being asked to use.

References 

  1. Cascade, E. Use and adoption of site- facing technology. Centerwatch, January 2016. http://www.centerwatch.com/news-online/2017/01/16/use-and-adoption-of-site-facing-technology/
  2. Digital in 2017 – Global Overview. https://wearesocial.com/special-reports/digital-in-2017-global-overview.

 

Elisa Cascade is an expert in clinical trial innovation and technology with over 25 years of industry experience. She leads DrugDev’s Data Solutions business working with sponsors, CROs, and sites to improve clinical trial operations through standardization, industry-wide collaboration (including TransCelerate’s Investigator Registry and Investigator Databank), and a beautiful technology experience. Email elisa.cascade@drugdev.com or tweet DrugDev at @drugdevinc.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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