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Building a technology foundation to support clinical development efficiency.
Tom Grill/Getty ImagesIt is clear that standalone systems to facilitate trials do not interoperate sufficiently to maximally leverage technology. The challenge then is to achieve an integrated solution with the next generation of technologies that are aligned to accelerate development. This article considers the eClinical technology foundation required to bring greater efficiency and productivity to clinical development. To explore this, we need to agree upon a definition of what eClinical is. eClinical means more than simply a clinical trial technology, such as an electronic data capture (EDC) system, but a combination of technologies that form an integrated solution. This integration should focus not simply on sharing data, but around simplifying the way individual applications operate together to smooth the workflow and access to information for the key technology end users: site personnel, study managers, study monitors, clinical supplies teams, senior management, regulatory, and pharmacovigilance teams. This changes our attention from purely data integration, to explore how end user workflow and processes can be operated seamlessly when multiple technology solutions such as EDC, clinical trial management systems (CTMS), and randomization and trial supply management (RTSM)—typically delivered using IVR/IWR technology—systems are in use together. Five objectives underpin the effective delivery of this definition of eClinical:
Data integration. Ensuring that key data are shared by appropriate applications—eliminating duplication of tasks and associated data reconciliation activities.
Convergence of technologies. Blurring the boundaries between applications by making functions contained within one technology product efficiently accessed via another. Convergence goes beyond data integration to making workflow simpler and more efficient and intuitive for users.
Data consolidation for decision making. Enabling users to access data that is extracted from multiple technology solutions and presented together to aid their ability to understand trial progress and data.
A common technology suite. Having a common navigation and look-and-feel for a collection of technologies to simplify training and usability.
Integrated service delivery. Providing integrated project management and support when an integrated combination of technologies is deployed.
This article will explore some of the key components of the technology platform that are required to deliver this vision of eClinical: a clinical technology integration platform (CTIP), identity management solution and portal technology, and an enterprise reporting application with associated information architecture. This platform must be capable of efficiently managing the complexity of interactions and data between systems within a defined suite of technologies, but must also be capable of interacting with the potentially more complex combination of solutions operated by other parties within the clinical trial network.
Until recently, most integration efforts in the clinical trials environment involved point-to-point solutions that require the creation of customized links between each application. These point-to-point connections between trial technologies provide significant benefits in removal of duplication of activities and data, and eliminate the need to reconcile common data between systems. However, there are inefficiencies and limitations inherent in this approach. Typically, point-to-point integration requires custom links to be built between each set of applications, and these usually require rebuilding for each study. In addition, because of the number of connections often in play, it is complex to support and maintain full visibility of all the moving parts in a single study—not to mention multiple studies. The number of point-to-point connections often required also means more complex testing and validation activities are required and potentially repeated should one solution be modified or upgraded mid-study.
The objective of the clinical technology integration platform (CTIP) is to provide the same data integration benefits in a more robust, repeatable, and supportable way. 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. Each application is connected via a single connection to the CTIP only, providing scalibility and increased supportability—these connections can be made in such a way as they do not require re-building for each study, but simply configuration. The CTIP controls the interactions between the systems, catalogs the data each system contains, and keeps track of what information each systems "needs" from the others. With a full audit trail and an activity monitor, this component of the eClinical platform provides full visibility of all the integrations and processes through a single interface, increasing the ability to support a high number of integrated technologies across a large number of studies.
In its simplest form, this approach achieves the same data integration as point-to-point integrations but does so in a more scalable and supportable manner. However, data integration does not need to be a synchronous exchange of data files, but some integrations have value when implemented in a synchronous manner using web services so that one application performs a live call of another system, inputting data, executing commands, and returning a response directly. This is one of the routes to product convergence and a way for the increased benefit of simplifying the workflow for the end user can be realized. To achieve convergence, however, may require adjustment to individual products to ensure the function can be delivered effectively and appropriately. Let's consider two examples of product convergence:
Enabling site users to utilize EDC to perform randomization and dispensing activities. Rather than create a monolithic application supporting full EDC and RTSM functionality, it is possible to use synchronous integration between EDC and RTSM to achieve seamless workflow. The user requirement is to action randomization, dispensing, and pack replacement events from within the subject records held by EDC, without having to exit the EDC application or log into another application. To achieve this, the CTIP must manage web service interactions between the EDC and RTSM applications to ensure that when a randomization event is actioned, for example, the appropriate subject data from EDC is transmitted to RTSM and the randomization number and medication pack numbers allocated are returned and presented through the EDC interface. To operate seamlessly, a number of modifications to the EDC application are required. First, during the EDC study design phase, the designer requires the capability to define visits that map to certain RTSM events and identify specific data points within specific eCRFs. These need to be provided to identify the subject and operate the randomization. Second, the EDC interface needs modifications to enable RTSM actions to be accessed simply, and the capability to report web-service status, display returned information appropriately, and alert the user to error details if a subject event cannot be performed for some reason—for example, the subject is not eligible. Behind the scenes, the application needs to be enabled for web-service operations. The end result, a converged product combining EDC and RTSM functionality, provides a single application for the end user to perform their workflow efficiently.
Enabling sponsor users to action user accounts for clinical trial applications directly from their CTMS application. CTMS applications contain the names, addresses, and contact details of many of those involved in operating a clinical trial—in particular, study site personnel. These provide the vital user details required when creating and managing user accounts for the required trial technology applications such as EDC and RTSM. Enabling CTMS to write these details into these applications and action automatic creation and distribution of user accounts would assist sponsor workflow and ensure that all applications contain the most up-to-date information when user details change. Again, implementing this concept requires changes to the individual applications. For example, CTMS may not contain all the user types and details required by the receiving applications, and changes to the user account creation and management processes may need to be implemented in the receiving application. This is just one example of convergence that could utilize CTMS to trigger actions in other systems.
This approach to simplifying workflow through appropriate product convergence can be brought further forward through the effective use of portal and identity management applications.
In its broadest definition, the Oxford English Dictionary defines a portal to be "a doorway, gate, or other entrance..." That in mind, portal software is an essential component of the eClinical-enabling platform as it can provide a framework through which to provide web-based access to a broad range of data and applications, consolidated through a single entry point. For example, entering the portal could give a user access to information (study protocols and documents, study news and announcements), data (study metrics and data reports consolidated from multiple applications, for example CTMS, EDC, RTSM, and others), and study applications they have rights to access, such as EDC. This is a critical component of further product convergence in providing a single framework from which all applications and activities can be accessed via a single log-on. Achieving this also requires an identity management application to ensure that users can be granted access to multiple applications via a single user ID, and ultimately that active sessions can be recognized between applications so that additional sign-on is not required.
As we consider how multiple applications can be presented effectively together through a common framework it is helpful to look at the example of the Apple iPhone. The utility and popularity of the iPhone are a result of three things: value—the convenience and usability that is achieved by the presentation of multiple applications through a single unit; design—great look and feel, intuitive navigation and (some would say) coolness; and quality—function underpinned by robust and reliable performance. Examining these in the context of portal and identity management software helps to focus on some key principles that should be aimed to achieve in bringing together data, information, and applications through a portal framework.
Value. We've stopped expecting to carry multiple devices to perform the things we like to do—phone, music player, camera, GPS—yet we have this precise expectation of our study sites and study teams whom we require to utilize more and more independent technology applications to perform their clinical trial activities. Portal software provides an opportunity to develop a framework within which all trial applications and data can be accessed with the appropriate rights and security. The portal, however, is only of value if it does not add to the burden of specific users but helps them to work efficiently. Site-sponsor collaboration portals, for example, can only be effective if they help sites to complete their work and activities and don't simply create additional tasks to perform for the benefit of the sponsor or CRO. Bringing applications together within a single framework provides value greater than the sum individual components when:
Users have a single point of authentication providing access to all their applications without multiple log-ons, achieved through effective use of identity management applications.
Data and metrics are consolidated from multiple databases such as CTMS, EDC, ePRO, and RTSM, and displayed in a user-role-specific manner that helps the specific user type understand their progress and manage their work, achieved through data integration and effective information architecture to enable data to be consolidated and reported effectively (Figure 1).
Figure 1: The portal provides a single view of high level study performance metrics with consolidated data from multiple clinical trial technologies.
Functions that live in specific applications can be exposed in a way that guides the workflow of the user. For example, the portal might bring together all queries from EDC, ePRO, imaging and safety systems and present them together as outstanding tasks to the site user.
Additional application portlets can be included that broaden the activities and information users can access, such as collaboration, news, and discussion areas.
The framework permits access to multiple studies, programs, and portfolios through a single entry point dependent upon the access rights of the user.
In creating iPhone, Apple has also created a framework standard enabling others to design and publish "apps." This is a value add for iPhone and the same holds true for a portal—additional value comes from a standard framework that makes it easy to construct new compatible portlets that can be applied in combination with others to comprise a specific portal application.
Design. Usability is a key requirement for any trial technology. Intuitive to use, simple navigation should enable the user to rapidly access the data, information, or function they require to perform their activities. Combined with an understanding of user-specific workflow, portal applications can present activities and data in a way that is able to guide the user to their most critical tasks and help them complete their work efficiently. The applications and data presented with most prominence may change depending on the stage of the study, making it easy for users to get to where they need to rapidly. Application of design principles and user interface standards will ensure that users do not have steep learning curves when utilizing new functions exposed through the portal. When providing or exposing access to other applications through the portal, common interface and navigation rules and standards make the use of a product suite more effective. Microsoft achieved this in the creation of their Office suite where diverse products can be used with a familiar and common navigation and interface.
Quality. All the above are great conceptually, but without a powerful enabling platform and well considered architecture and infrastructure it is unlikely to be successful. Users seek reliable and robust solutions that improve and aid the completion of their required activities.
As an industry we may have some way to go to deliver the vision described above, but knowing the vision enables us to determine the steps toward achieving that end game.
Each technology used in clinical trials contains data from which valuable reports can be delivered. One problem is that a user, such as a trial director, may have to visit the reports contained in multiple applications to obtain the information they need. These reports display the data in different styles and formats—meaning that if you were to compile these into a summary report the result would be a mismatch of styles and formats. This makes it difficult for the reviewer to easily interpret the contents due to having to reorientate when viewing data presented using a variety of approaches. For example, bar charts created by two applications may present country totals using an alternate color key and differing axis scales. Studies have shown that the use of color can be used to make quick association; conversely, inconsistent color schemes can confuse. Utilizing a common reporting technology and applying consistent reporting standards facilitates this.
Devising an architecture that enables data from across multiple applications to be consolidated in a warehouse or mart means that all essential data from multiple technologies can be accessed and reported alongside each other through a single interface. More importantly, pulling together data from disparate applications can provide more valuable metrics and insights. An example is measurement of the data visibility gap. An RTSM system contains real-time data on patient visits, as randomization and dispensing actions within RTSM are performed while the patient is in clinic. This data provides insight into the progress of other activities—for example, how long does it take the site to begin the data entry activities on the EDC application, or to ship a medical image to the core laboratory. Consolidating the data from these applications in near real time facilitates such measurements. In turn, a CTIP technology readily enables consolidation, ensuring that the data warehouse or mart is fed with up-to-date data from each solution.
An important consideration around implementation is data security. In the individual technology solutions, access rights within the application controls access to data (or subsets of the data). For example, within RTSM certain users such as those managing clinical supplies may require access to unblinded data to monitor the usage of medication units within each treatment group. Access to this data is controlled through the rights management of the RTSM application. When you remove the data from the RTSM application, you need to apply the same security rules to ensure users are only exposed to data their role type allows. This is one of the methodologies that can be applied by an identity management solution.
Achieving this vision for the future requires a powerful enabling platform composed of the right building blocks to enable the delivery of fully integrated and interoperable systems to support comprehensive data access, streamlined workflow, and overall greater efficiency improvements in clinical development. This vision is focused not simply on providing advanced and tighter integration between a defined suite of products, but also on providing a framework to enable effective interaction with a complex collection of applications hosted remotely by other organizations. Only then will there be effective information flow across various functions and organizations involved in executing clinical studies. A key goal is to enable greater visibility into trials and improve data access for faster, better decision making.
Bill Byrom, PhD, is Senior Director of Product Strategy, Perceptive Informatics, Nottingham, UK, e-mail: Bill.Byrom@perceptive.com.