MM&M (Medical Marketing & Media): Director of Commercial Strategy and Innovation at Cadient Group, a Cognizant Company, Shares Guidelines for Pharma to Leverage Apple’s ResearchKit

“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,” writes Ken Fabianovicz. Excerpts:

“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.

Get the right people in the room early: 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.

Reimagine awareness and recruitment: 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. 

Keep protocol design in harmony with technology: Using the iPhone will not make sense for every trial, especially since iPhone user demographics may not be representative of the target population. 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.

Start with the patient: 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.

Remember — ResearchKit is open source: [ResearchKit being an open source project] 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!

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.”

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