Implementing mHealth in Your Next Protocol

UBC is focused on expanding mobile tactics for clinical trial programs

Implementing mHealth in Your Next Protocol

The second part of my series on mobile health (mHealth), Leveraging Mobile Health through Innovation, focused on expanding the use of mobile tactics for clinical trial programs and highlighted some examples of cutting edge technology. Hopefully it gave you a few ideas to bring to your own study teams. 

But you may be asking yourself, what’s next? What are the steps in determining how and when to incorporate mHealth technologies into your trial strategy? In this third and final installment of my blog series on mHealth, I’ll answer those questions, as well as provide suggestions for program set-up and funding.

There are a number of factors to consider when deciding if your trial may be a good fit for implementing a mobile technology:

  • Protocol - Does the protocol lend itself to the use of mHealth tactics? Review the schedule of assessments to see if any of the trial data can be captured electronically without the patient going to the site, and/or if mobile technology can be used for studies that require continual patient engagement for retention and increased compliance. Will the study rely more on patient-reported data or investigator assessments? Can the device collect the necessary specimens required in the study? Mobile technologies may not be as cost effective for studies relying heavily on investigator assessments or on specimen collection in the absence of a supporting mobile device technology.
  •  Patient Population - The study demographic often dictates how practical and effective a proposed technology may be. For example, while remote health monitoring (i.e. TeleHealth) has been successfully used for years, some new mobile technologies rely on wireless Internet access, which may not be as readily available in certain areas or among older populations. Some patient populations also have special needs that require more face time with the physician, and in those cases biometric and other data collection may be best done at the site. 
  • Data Integrity - Device-specific checkpoints and confirmations are a must. Without clean and quality data at the source, site staff are likely to assume a significant data verification burden.
  •  Adverse Events - The system should include patient prompts to ensure that AEs are reported to a live person as soon as they occur. 
  • Technology Adoption & Operations Management - Flexible user management allows investigators and sponsors to more effectively coordinate trial operations.
  •  Device Shipments - For global studies, device usage and delivery must be customized per in-country regulations.  All relevant languages must be supported, and all country-specific privacy regulations must be observed.
  • Remote Monitoring - The ability to monitor data remotely, via reports that sync device data with the EDC, provides for optimal cost savings and efficiency.

Once you've matched your trial with a set of appropriate mHealth tactics, you need to get executive buy-in. Let's consider a few approaches to navigate the path to executive support:

  • Toe in the Water - Consider positioning the use of mobile technology in your trial as a pilot. I find that the use of the term “pilot” is synonymous with “low risk” and “low exposure.” By positioning the use of these newer technologies as part of a Pilot, you have an opportunity to test a variety of tools and approaches. This approach also gives you a chance to collect metrics and feedback – something senior management is always interested in.
  • Find a Friend - Gain the support of an internal champion. An internal champion is a person within your organization who takes extraordinary interest in the adoption, implementation, and success of your project/product. He/she will evangelize it through the organization. This person ideally is at the executive level of your organization but can also be someone who has a very successful “track record” of successful trial management.
  •  Show Me the Money - Finding the funds for mHealth initiatives can be a challenge, especially for studies without a lot of wiggle room in the budget. One way to work around the problem is to think of an mHealth strategy as a substitute for some of your existing processes, rather than an add-on.  Start small if you have to, and implement the new technologies at only a handful of sites instead of across the board. Collaborate with other groups as a way of reducing costs and tapping into other possible funding sources. Some pharma companies have whole teams dedicated to finding innovative ways to approach business processes—they may be excited to help you champion something new. Let the innovators assist you in bringing your mHealth initiatives from concept to reality.

Today,  I will be speaking at the mHealth Summit. I look forward to sharing an overview of a study I have been working on that leverages many of the concepts I’ve discussed in this series of blog posts.  I’m excited to provide information about one of our partners – Telcare – and their wireless glucometer, and how it is being used for biometric data collection.

I hope you found this mHealth series informative, and that it gave you some ideas on how you can make changes to your current clinical program to be more innovative and in line with today’s quickly evolving mobile trends.

See you at the Summit!