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.
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