pharmatechoutlook

New Unfoldings in Pharma Compliance

By Thomas N O’Leary, CIO, ICON plc

Thomas N O’Leary, CIO, ICON plc

An Overview of the Current Market Trends Shaping the Pharma Compliance Ecosystem

The use of mHealth (mobile health) technologies are increasingly being embraced by patients, healthcare providers, and payers alike. While connected health ecosystems have been evolving at a rapid pace, it has been estimated that today over seven million patients worldwide benefit from remote monitoring and the use of connected medical devices as part of their care regimen.

Primary Challenges and the Best Practices for Ensuring Compliance

mHealth technologies enable the capture of more real-time data onthe patient as they carry out their normal daily activities, which results in better quality information being delivered on a drug or devices, with minimal burden on the patient or the physician site. mHealth device technology has evolved to the point where it is now possible to collect a vast array of physiological data. This not only includes vital-signs such as heart rate, respiration rate, oxygen saturation, continuous glucose monitoring, sleep and activity data, but also the use of advanced analytics to monitor patients in their own home outside of the hospital environment. There is a growing awareness in the healthcare sector of the benefits and value of a mHealth approach to healthcare; however some of the challenges continue to exist relating to the implementation of this technology in clinical trials. These challenges can be experienced in areas including device suitability, data privacy and security, and regulatory acceptance.

"Compliance monitoring can be a significant contributor to the success of mHealth trials"

The collection of data on the patient needs to be as seamless as possible with minimal actions required from the patient. Another important aspect for increasing patient engagement is through selection of a low-burden device that is simple to use with an attractive form factor. It is recommended that devices should— where possible—support both iOS and Android operating systems to allow for a successful BYOD model. A single study app, which acts as the interface between the individual and the trial and includes features to support the patient in his/her day-to-day life, is also recommended. Compliance monitoring can be a significant contributor to the success of mHealth trials. Using technology to proactively flag non-compliance and utilize a multi-faceted approach to engage with patients—from app to SMS notifications to direct contacts contacting patients—can help drive greater compliance and ensure optimal data generation and capture. As with all technologies which collected personal data it needs to be done in accordance with GDPR requirements.

The Best Approachto Identify the Right Partnership/Solution Provider

New providers with new capabilities appear on the market almost every month, so selecting the right device is a challenging task and poses a number of critical questions; how to evaluate? Should we use single or multiple devices? Medical grade devices or consumer technology?

Unfortunately, there are no simple answers, and certainly, there is no one device that can be used in all clinical trials. Of primary importance is the selection of a device that can generate the data required to meet the study needs. The device itself must have high usability, i.e., a good battery life, and must facilitate the collection and transfer of the required data. The trial design will also inform the device(s) selection process; if a device is being selected to support an endpoint, ensuring there is sufficient scientific evidence to support the use of that device is critical.

Upcoming disruptions within Pharma Compliance space

It is evident that data is meaningless without context. In order to turn data into information and actionable insights, data analytics forms an imperative piece of the puzzle. As was described in a press release earlier this year, ICON is doing some very interesting work on the use of the Intel Pharma Analytics Platform. In this engagement we are evaluating the data from a number of sensor devices, all at the same time. We are looking for correlations across these data, which previously may have notbeenconsidered in order to generate new insights that have the potential to be clinically relevant.

The potential to generate new insights from continuous measures captured—as patients go about their real-life—is significant. This is similar to motor vehicles using camera and recording technologies to monitor driver behavior, and customize insurance plans. The use of mHealth technologies will provide the opportunity for patients to more proactively monitor their disease and conditions in a way that wasn’t possible heretofore.

Advice for Budding Entrepreneurs

Leaders must provide the evidence of where they have overcome challenges with their devices. It is also crucial to maintain early engagements with the regulatorspossessing roadmaps and recommendations. These recommendations play an important role as references when considering the incorporation of latest technologies in trial designs.

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