Thomas Santarelli

Three of the largest challenges regarding clinical trial success are patient recruitment, retention, and compliance to treatment regimen. To meet these challenges, the use of interactive voice and web response systems (IVR/IWR) has proven to be effective in the management and execution of clinical trials, as they provide an opportunity to track patients throughout the clinical trial lifecycle. 

A number of growing trends in clinical trials, such as the increasing importance of electronic patient reported outcomes (ePRO) and the explosive growth of social and new media and mobile technology, have converged over the past decade, resulting in new opportunities and challenges to increase patient compliance. While there have been strides with various interventions in chronic healthcare settings to improve patient compliance (such as remote monitoring), new interventions are needed, particularly given the unique challenges associated with compliance in clinical trials. 

Emerging communication modalities like SMS text messaging and mobile applications (apps) enable such novel approaches that will enhance direct-to-patient communication and clinical trial engagement. More fully leveraging mobile technology allows us to draw from an array of communication modalities and more flexibly tailor direct-to-patient reminders and outreach to study-specific logistical, clinical, or financial considerations to improve patient satisfaction and drive compliance. 

It is all but certain that the technology landscape will continue to evolve as the demographics of clinical trial patients follow demographics of the general population. Historically, the "Baby Boom" generation drove the adoption of hand-held mobile telephones in the 1980s and 1990s. Generation X, successors to the Baby Boomers, drove the adoption of convergent technologies, including smartphones. Current generations have become reliant upon their mobile devices to help orchestrate their lives, resulting in additional technology convergence among various computing platforms. 

 For example, historically, financial institutions sent monthly paper statements to customers to provide account information. More recently, financial institutions have begun offering status information and reminders via e-mail and text messages. These methods of delivery, while intended to augment web portals, have reduced web portal traffic as financial institutions push status information off of websites and toward mobile devices resulting in nearly instant access to financial information. 

With the rapidly expanding use of mobile technology and quickly evolving or converging technology surrounding it, vendors must enhance solutions to existing technology stacks to support non-transactional information delivery like reminders. Since such bolted-on solutions were an adjunct to the core architectural vision of those early systems rather than an integrated part of a unified architectural vision, they were frequently inflexible and difficult to maintain, resulting in the inability to sustain innovation since the core architectures simply didn't support it. 

 Recently, technology platforms and methodologies have become available that enable architectures to support innovation in the ePRO space. There are three technical disciplines unpinning these shifts: data-driven design, service-oriented architectures, and event-driven communication mechanisms. Earlier systems evolved from understanding of the delivery modalities required, namely web- and phone-based transactional support. The organization of the underlying data followed from understanding the delivery modalities. The resulting systems consisted of commingled data from different solution domains (web and phone) that made enhancing those systems problematic. If one needed to change the web functionality, phone functionality must be regression-tested to ensure that a web enhancement did not affect it. Current application architectures advocate a data-driven design wherein the data is carefully separated from the data-delivery modalities. The data is then organized in vertical domains where the interaction between domains is controlled and orchestrated. Changes can be made within data domains without affecting other data domains. Thus, development is accomplished faster and more accurately. 

Once the data is arranged in logical domains, it must be exposed for consumption to external applications. Service-oriented architectures (SOA) fit cleanly into the data-driven designs. SOA allows data domain interfaces to be clearly defined via a variety of industry standard interfaces. These include Internet-friendly technologies like web services. Applications that consume data simply aggregate calls to the SOA components to find data within the domains without corrupting the integrity of the data domains themselves. The resulting solutions are easier to develop and maintain because unexpected data interactions are minimized. 

The final piece of the technology puzzle is the ability to provide event-driven communication mechanisms to and from the SOA components. This is important because many of the non-transactional delivery modalities are triggered by data changes within the data domains. For example, text message reminders are triggered by timing dependencies defined by patients and the protocol. In other words, the text message delivery mechanism is a "subscriber" to the patient data domain which "publishes" the data that is sent to the patient. The publish/subscribe mechanism allows a clean division between data generation and data delivery in highly event-driven scenarios like text messaging and e-mail. Taken together, data-driven designs, SOA, and event-driven communications comprise core architectures for supporting current ePRO compliance needs and a robust framework for supporting future ePRO compliance mechanisms not yet envisioned.  

In summary, current technologies have helped to change patient expectations of how ePRO compliance is maintained. In order to successfully drive the engagement and compliance of each patient, technology must emphasize flexibility to accommodate their varying needs, lifestyle, and technology patterns. Many of the architectural approaches taken by vendors to innovate in the face of these changes often resulted in unsustainable innovation. More current data-driven designs combined with service oriented architectures and event-driven communication mechanisms hold the promise of more robust ePRO compliance platforms and allow for sustainable innovation. 

 is Vice President, New Products and Services, e-mail: 

is Group Leader, NPS, both at Almac, 25 Fretz Road, Souderton, PA 18964.

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Constant technological advancements continue to alter the compliance battle.

Thomas Santarelli

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Sustaining Innovation