Last week, with the announcement of Apple’s ResearchKit, Sage Bionetworks in Seattle enrolled more than 7,000 Parkinson’s patients in a single day for their Parkinson’s study. As a point of reference, the largest clinical trial ever conducted for Parkinson’s had just 1,700 patients.
This incredible surge in enrollment is a dramatic indication that the scale, speed, and accuracy of basic medical research is about to increase exponentially. For clinical trials conducted by pharmaceutical companies, the impact of ResearchKit also holds great promise – but, for a variety of reasons, that promise may not appear as quickly or dramatically as will be seen for basic medical research.
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To gauge the potential impact of ResearchKit on pharma, it’s important to recognize the specific challenges facing clinical trials and to imagine how, and if, ResearchKit will address these specific issues. With that in mind, here are five guidelines for pharma to focus on as the industry begins adapting to this powerful new medical research platform.
1.Get the right people in the room early
Even before the launch of ResearchKit, digital technology had been significantly transforming clinical trials, and there are a growing number of experts who have experience with both clinical trials and the associated technology. Make sure you reach out to your IT team and/or digital agency to understand the limitations and gaps of the digital technology and determine the role that these technologies may play in supporting your study objectives. Regulatory and legal stakeholders should also be involved early in order to address privacy and regulatory requirements.
2. Reimagine awareness and recruitment
As demonstrated by Sage Bionetworks’ Parkinson’s study, ResearchKit is significantly raising expectations surrounding patient awareness and recruitment. However, for clinical trials, which place a high premium on enrolling the appropriate patients, ResearchKit will not necessarily be a panacea. Trial recruiters will still need to craft a patient story that resonates by answering key patient questions:
- What is the trial for?
- What is required from me?
- How long will it take?
Telling this patient recruitment story in a mobile first world requires that trial recruiters reimagine how they will reach their potential patients, as well as how they’ll tell their well-crafted story.
3. Keep protocol design in harmony with technology
Not surprisingly, Apple’s marketing team positioned ResearchKit to be an indispensable necessity for every patient and researcher in the entire world. Despite what the Apple marketing team would like us to believe though, using the iPhone will not make sense for every trial, especially since iPhone user demographics may not be representative of the target population. In fact, a recent Pew Research Center study found that “those from the upper end of the income and education spectrum are much more likely than those with lower income and educational levels to say they own an iPhone.”
In addition to potential issues in finding an appropriate population sample, some clinical studies require frequent and complicated lab assessments. This does not rule out the use of ResearchKit apps per se, but for complicated trials ResearchKit may only add value as a patient reminder/scheduling tool versus an actual diagnostic component of the trial.
4. Start with the patient
Steve Jobs was focused on putting the customer experience first–“You’ve got to start with the customer experience and work back toward the technology, not the other way around.” This perspective is especially important in terms of clinical trial design: how will participants feel about their overall experience? What perception will they form of your company and what will they express to their friends and family about the experience? The patient trial experience is more than just testing and technology: it encompasses the entire range of communications, interactions and human quality of the trial. In other words, if you design a beautiful app, but have a terrible call center support experience, guess what impression your patients will remember?
5. Remember — ResearchKit is open source
One of the more surprising aspects of the ResearchKit announcement was that Apple made it an open source project. This means that both corporations and nonprofits will be able to leverage a global ecosystem of innovations and apps. For clinical trial teams, take the time to investigate and even participate in this ecosystem! Many of the tools and tactics you need for your particular trial could already be available via the ResearchKit community.
We are still in the very early stages of ResearchKit. But based on the success of other Apple development platforms and ecosystems (like the App store), it’s safe to say that ResearchKit will rapidly grow in influence and diversity of solutions. In this fast-moving environment, we believe these five guidelines will help guide your clinical trial team in taking full advantage of this exciting new platform.
Ken Fabianovicz is director of commercial strategy and innovation at Cadient Group, a Cognizant Company.