Understanding mobile health trends and opportunities for clinical trials

Mobile health is certainly a hot topic when it comes to patients monitoring their own health and pharma companies seeking deeper engagement with healthcare stakeholders, but Abbe Steel also sees a big application in facilitating more efficient drug development.

Mobile Health (mHealth) encompasses any patient health information accessed using mobile technology, such as a smart phone, tablet, or other wireless device. These health applications, or apps, provide diagnostic and treatment support, remote monitoring, data collection, awareness, wellness, training and education, and tracking.

Many of us are familiar with apps that help us track our caloric intake or log our activity. But apps can also be used to get lab results by phone, manage medications, and share health information instantly. Not only are more and more people using mobile devices to access medical information and download health applications, but physicians are increasingly relying on this technology to provide a portion of patient care and to receive information on the latest medical breakthroughs.

The emergence and popularity of patient-centric applications provides a great opportunity for pharmaceutical manufacturers to engage patients and create a customized, direct relationship with them. And the clinical trial space provides an excellent channel to leverage these technologies. The integration of mobile technology in new clinical trial designs and business strategy development holds promise for aligning site and patient needs with faster study execution and reduced costs.

Mobile technologies are already being used in clinical trial recruitment and retention, with the capacity to be used even more. Specific studies and opt-in databases have the potential to:

• Provide patients with access to studies they would not otherwise know about

• Allow investigative site staff access to several different formats of study materials and tools

• Offer site training in different iterations depending on the audience

• Personalize patient retention activities such as visit reminders, medication and diary reminders, and newer retention techniques such as gamification and online communities

Some of the newer technologies that have made their way into clinical trials designs include:

Bring Your Own Device (BYOD): BYOD approaches allow study participants to use personally owned mobile devices (laptops, tablets, and smart phones) to send/access privileged study information and applications. Although there are significant issues to address – security concerns, HIPAA compliance, and the uniformity of the user experience – BYOD approaches may help patients be more compliant to study requirements, and could potentially increase patient retention because of the convenience of using their own devices.

"BYOD approaches allow study participants to use personally owned mobile devices"

Disease-specific medical devices: Wireless health devices (such as wireless glucose monitors or vital sign recorders) can be used to relay information to study sites. Depending on the protocol, portable hand-held devices that transmit data wirelessly might be considered, eliminating the need for some study mandated visits. With a wireless device -- for example, a spirometer for a chronic obstructive pulmonary disease (COPD) study -- the study site staff can monitor the measurements patients obtain using the device in real-time along with all other electronic data being collected in the study.

Study-specific mobile applications: As an alternative to investigator kits to provide sites with reference material, mobile apps can provide a great deal of information in a more efficient and cost-effective way. Push alerts can also notify the sites of updates such as protocol amendments.

ePRO platforms: An ePRO (patient reported outcomes) platform can allow manufacturers and clinical research organizations to utilize a BYOD strategy. As hardware provisioning has made ePRO expensive, utilizing a BYOD option has reduced its uptake.

Text messaging: Many clinical trial patients choose text messaging over other response options such as phone and email and have shown a willingness to provide a large amount of information to determine their eligibility.

When is mobile health a good fit?

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 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 is 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 electronic data capture, provides for optimal cost savings and efficiency.

"There are many opportunities to utilize mHealth strategies, apps and devices into a clinical program"

There are many opportunities to utilize mHealth strategies, apps and devices into a clinical program. And while there are important considerations when incorporating an mHealth solution in a clinical trial, this quickly evolving (and exciting) trend truly captures the new frontier of patient engagement.

About the author:

Abbe Steel, Vice President of Patient & Physician Services, United BioSource Corporation (UBC), leads the patient-directed initiatives for clinical trials and commercial programs within UBC's Patient and Physician Services group. Her programs include uniquely customized, data-driven, health technology solutions to support patients in the commercial or clinical setting. She manages a team of experts in medical communications, data analytics, and technology, to drive innovation in clinical research and post-marketing programs.

Abbe has more than 23 years of experience working in the pharmaceutical industry in the fields of patient education and adherence, drug safety/risk management, clinical trial management, and patient recruitment and retention. Previously, she worked at Sanofi, supporting patient compliance and product marketing initiatives; at PAREXEL, responsible for investigator and patient recruitment and education,; and at a Health IT start-up technology company acquired by Cerner.

Abbe received her degree from George Washington University. She continues to expand the team's capabilities and reach by establishing strategic partnerships, building new products, and leading challenging and innovative studies. She can be contacted at abbe.steel@ubc.com

Closing thought: Where is mHealth most useful in clinical development?