Featured Viewpoint: eClinical Convergence

True eClinical: Advancing beyond data integration

The clinical trial process has benefited substantially in recent years from the use of first-generation clinical technologies such as Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM) systems, Clinical Trial Management Systems (CTMS), and electronic Patient-Reported Outcomes (ePRO) solutions.  While these systems have greatly enhanced the efficiency of individual clinical processes, their ability to improve efficiencies across functions, share information and transfer data remains limited when used in isolation.  

As a result, much of the development effort for the second generation of clinical technology solutions has been focused on improving data integration and interoperability between functional areas and systems.  The concept of using middleware/integration platforms is rapidly gaining acceptance as a way to improve integration between systems.  For example, a clinical technology integration platform (CTIP) provides substantial improvements in data interchange between separate clinical systems and addresses some important data integration issues.  However, most users must still log in and out of multiple applications in the course of their daily activities to access the full range of information they need to conduct and manage a trial.  

The next generation of clinical technology solutions goes far beyond the integration of data between systems – providing business-process-driven solutions that are aligned with user workflow for sites and sponsors across key clinical functions.  These are what we define as true eClinical solutions.   By leveraging technology to optimize the way sites and sponsors manage clinical trials and access data,  eClinical solutions provide greater value to the biopharmaceutical industry.  They create a new operating model that streamlines the development process, eliminates redundancies, reduces trial delays and increases patient safety – improvements that go well beyond simply automating outdated processes.  At the same time, eClinical solutions provide the integrated data sponsors need to make better clinical decisions faster – a top priority for every biopharmaceutical company.  To achieve these goals, however, companies creating eClinical solutions must have an in-depth understanding of the clinical trial process, as well as experience developing clinical technology.

Focusing on the end-user experience
The concept for realizing the full benefits of eClinical solutions is to blur the traditional boundaries between various clinical applications by providing the user with an interface that simplifies key processes and provides access to essential trial data quickly and easily.  A good example of this approach from another industry is the smart phone – a single device that integrates access to a variety of independent applications such as email, scheduling and web browsing, using an intuitive interface.  The user can retrieve and exchange important data from various applications without having to log into them individually – a concept that has revolutionized mobile communications and greatly enhanced the productivity of its users.

A critical objective for biopharmaceutical development is to provide site personnel with a similar type of integrated data access to multiple clinical technology systems through a single interface.  In most clinical settings today, study directors must routinely check multiple systems to gather the data they need to effectively manage a trial: RTSM, for real-time study progress and information supply chain logistics; EDC, to monitor the data management process, query resolution and data verification; CTMS, to view performance against trial milestones and budgets.  Although some information may be common to each system, it is difficult for managers to see all the information they need in one place.

Until recently, most technology integration efforts in the clinical environment involved point-to-point solutions that require the creation of customized links between each application.  While point-to-point connections provide some integration benefits, they require custom links to be built between each set of applications for every study – making them relatively costly and inflexible.  A Clinical Trial Integration Platform – built upon the enterprise-class middleware technology – overcomes these shortcomings and provides a better path to data integration.  The CTIP is a software platform or hub that sits in the “middle” of other applications – serving as a central platform that facilitates and manages all interactions between multiple technology systems.  The CTIP requires little or no change to the underlying applications, and each application requires only one connection – to the CTIP.  Once the connections are created, the CTIP manages all of the interactions between the systems, catalogs the data each system contains, and keeps track of the information each system “needs” from the others.  This automated data exchange facilitates seamless sharing of information between independent systems and provides a single view of the linked systems, so a sponsor or CRO can access, search and organize all study-related data from the linked systems through one central location.

Web services and related Internet technologies represent another set of integration technologies that enable clinical applications to share data among themselves – regardless of the underlying programming languages and platforms.  Web-based clinical portals are revolutionizing the way clinical trial information is gathered, exchanged and integrated – allowing authorized individuals anywhere in the world to share data such as trial milestones, study metrics, protocols and documentation, 24 hours a day.  

By leveraging CTIPs, web services and other related Internet technologies, study managers are able to access, search and organize key study-related data through one central location – a capability that enables faster deployment of studies, improves user productivity, and supports better decision-making throughout the clinical trial process.

Moving beyond data integration
Although CTIPs and web portals significantly enhance data integration, there are other aspects of technology development that can improve trial efficiency and increase the value of clinical technology:

Product convergence – One way to improve the user experience with core clinical technologies is to enable certain functions of one system to be accessed from other applications – a concept we call “convergence”.  For example, if trial sites are using an EDC system to perform their primary data-collection activities for patients, it would be optimal for them to be able to randomize patients and dispense medication without having to exit the EDC system and log into the RTSM system.  Users would be able to perform all of their key patient-level activities through a single interface and a single logon.  Such a product convergence is not simple, because it requires modifications to the individual applications and the implementation of an integration interface.  Equally important, it must be based on an in-depth understanding of how sites typically use the technology.  If implemented correctly, however, this blurring of the typical boundaries between systems can save considerable time for users and greatly simplify their use of multiple technologies.

Common technology interface – Although software suites with a common user interface are the norm in many industries today – with Microsoft Office being the most prominent example – most clinical trials continue to utilize multiple systems from different providers.  This approach requires sites and sponsors to learn a variety of applications, which reduces efficiency and increases data errors.  However, software providers in the biopharmaceutical industry are moving toward expanded suites of products for clinical trials that utilize a common look and navigational structure.  The accomplishment of this objective will be a key component in the vision of eClinical by greatly improving user productivity.

Integrated service delivery – The vision of a successful eClinical solution requires not only integrated technologies like those mentioned above, but also innovative services and in-depth expertise to implement the systems and improve efficiency throughout the product development process.  Sponsors are increasingly focused on core competencies such as research, product acquisition and market expansion, while relying on CROs or other strategic partners to deliver solutions that combine technologies and services to deliver the desired results.  Finding the right partner is the final component for the successful implementation of an eClinical solution.

Given today’s challenging healthcare environment, biopharmaceutical companies must accelerate their implementation of true eClinical solutions to spur the next wave of innovation in the conduct of clinical trials.  With those advances, sponsors will be able to make better development decisions, reduce trial costs and accelerate time to market.  The result should be safer and more efficacious products that reach patients sooner, at a lower cost – a benefit for everyone.