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) 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.
The biopharmaceutical industry benefits in many ways when data is captured and disseminated quickly, Jewett says. Sponsors and CROs can respond to issues as they arise, not six months after the fact.
As a result, he says, firms can reap the benefits of a competitive advantage and, at a trial's conclusion, provide product differentiation data and other information to health insurers. Plus, Grice points out, data collection can even continue once a clinical trial has ended, with patient data potentially ported to an electronic health record (EHR) system.
Support, Paper-to-smartphone Migration Pose Biggest Challenges
That said, smartphones do present use case challenges to clinical trial sponsors.
Help desk support, for example, may need to encompass "every phone in the world now, plus all the ones coming out next week and all the ones coming out next year," Grice says. Also, it's tough for a risk-averse industry such as biopharma to keep up with constantly changing, emerging and diverging messaging protocols.
Finally, Muehlhausen notes, there are old versions of mobile operating systems floating around, so the clinical trial apps of today and tomorrow need to be backward-compatible, "hybrid" solutions.
Content validity also matters. When migrating surveys from paper to the Web to smartphones, you can't change the way patients interact with a question, Muehlhausen says. "I'm a simple guy. You measure what you say you measure. The patients must understand the questions and the answers."
When building apps, he adds, it's important to make sure patients can understand how a question has been reprogrammed. Going from circling an answer on paper to touching an answer on a screen is one thing, but more substantive changes that could alter how a question is interpreted must be considered carefully. As that happens, as questions such as the following:
- Is it clear that they can choose more than one response for a multiple-choice question?
- Do surveys look dramatically different to iOS users vs. Android users?
- When is it OK to offer different modalities without sacrificing content validity or the ability to pool data?
- Does the survey get confusing if more than one question is displayed on a small smartphone screen?
When Incorporating Smartphones in Clinical Trials, Start Simply
Before adding smartphones to a clinical trial, Grice recommends conducting a risk assessment. This is for regulatory and privacy purposes but also to identify a program's goals and to understand the trial's patient population—namely, their access to the technology and familiarity with it.
Grice describes the best places to start using new technologies as late-phase, "supplemental opportunities" that don't immediately replace the clinical trial approach. Focus on collecting experience and equivalence data, particularly as it pertains to patient engagement, and don't lose sight of the overall goal of your initiative, he says.
Zielinski says the biopharma industry as a whole should closely study crowdsourcing initiatives and the ever-growing number of devices that plug into smartphones to gather personal health data. As these disruptive innovations make more and more patients "experts" at data collection, the clinical trial process could fundamentally change.
"Technology development is outpacing our ability to…manage it," Zielinski says, adding that it's "getting to the point that we are no longer the experts in gathering data from patients."