Like many parts of the healthcare process, the clinical trial is poised for a technological makeover.
In a session at the recent Drug Information Association's DIA 2013 conference in Boston, Gregg Jewett, global category leader for research and development procurement at AstraZeneca, notes that roughly 35 percent of patient-reported outcome (PRO) or clinical outcome assessment (COA) data is captured electronically. "What year is it again?" he asks.
Moving largely paper-based clinical trials to the Web-and, in a nod to the corporate bring your own device (BYOD) ( BYOD) movement, to patients' own smartphones-would offer trial sponsors and the contract research organizations (CROs) they work with more accurate and more timely data, Jewett says.
But getting to that point will require disruptive innovation in an industry that, for understandable regulatory and patient safety reasons, is often slow to adopt new technology. As Willie Muehlhausen, vice president of eCOA and innovation for the CRO ICON plc, puts it, it wasn't until 2012 that he saw Internet access as a requirement for patients participating in a clinical trial.
Improving Clinical Trials With Incremental Tech Usage
In the natural progression of clinical trial data entry, there are a few options for the first step forward.
- Digital pens for filling out paper documents present no training obstacles, Muehlhausen notes, but they are expensive devices that often lack alarms or edit checks.
- The learning curve for integrated voice response system is small, he says, but it can be "arduous" for long exercises.
- The SMS message provides a date/time stamp and lets trial sponsors send alerts to patients, notes Anne Zielinski, global lead for patient cloud systems at Medidata Solutions Worldwide, but it's also subject to a wireless plan's data charges and can be difficult for some patients to use.
- Finally, a single-purpose handheld device that's often unique to the trial itself can works well for ensuring that high-quality data is collected, says Kenneth Grice, associate director of ePRO operations for Bayer Healthcare, but it often leaves trial sponsors at the mercy of device vendors for a "range of ancillary processes" such as application development, logistics, data hosting and help desk.
Facing these challenges, clinical trial sponsors and their CROs are exploring the use of Web-based surveys (known in industry terms as "instruments"). The Web is widely available, and the large screen on desktop and laptop computers means survey formatting doesn't need to change much, but websites and Web apps don't work if a patient's offline. The same is true of the mobile Web, Muehlhausen says, even if, thanks to BYOD, it comes with the advantage of lower overhead costs for trial sponsors.
Smartphones Offer Promise for Clinical Trials
Mobile apps, then, may be the answer. As Zielinski points out, they offer numerous advantages over traditional clients and Web apps: Ease of use, better connectivity, the ability to work while offline, and integration with devices such as glucometers and blood pressure monitors, not to mention electronic data capture (EDC) systems. In addition, trial sponsors or third party service providers can configure the software as they wish, and software itself is much easier to distribute than hardware, Muehlhausen adds.
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