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Over the past two decades, the ultimate goal for eClinical has been the development of large integrated systems that serve a broad range of clinical trial operations, spanning CTMS, EDC, IVRS/WVRS, document management, and more. Integrated eClinical systems deliver many benefits, including fast and accurate data-transfer across functional areas, combined metrics, and sophisticated performance reports.
But these large-scale information systems are inherently complex and expensive, with long lead times to develop and a mixed record for delivery. The leading global pharma companies have the deep-pocket funding and long-term outlook necessary to develop such systems, but that’s not the case for a host of other players in clinical research, such as small- and medium-sized pharma, biotech and device companies, and their partners among CROs, academia, and foundations.
Does this mean that eClinical solutions are the sole province of Big Pharma, and other players must settle for traditional paper-based processes for clinical trials? Certainly not, but “the rest of us” must take a more practical approach to selecting and investing in eClinical solutions. Borrowing from a familiar acronym, let’s call this the “keep it simple,” or the KIS eClinical approach.
The challenge of KIS eClinical is to develop solutions that meet the stringent demands of clinical research while at the same time being practical and affordable. Ideally, KIS eClinical systems should meet a demanding set of goals, such as:
In some cases, it might be impossible to meet all the criteria above. For instance, for smaller and briefer studies, the advantages of automation may be too slight, and it may make more sense to rely on traditional paper-based solutions. But in other cases, KIS eClinical solutions are possible and can be achieved by following keep-it-simple principles.
The best way to arrive at an affordable IT solution is to build it once and have it yield value over multiple instances. KIS eClinical requires the use of pre-built, stand-alone solutions that require a minimum amount of work to use for the next study. Pre-built solutions can be designed to accommodate a wide variety of studies, and include screens and templates that are easy to populate with study-specific information and documents. It’s vitally important to focus eClinical systems on core functions, and avoid layering on non-core “nice to have” functionality. Affordable systems minimize strain on internal IT departments for hosting, integration, and validation. Simplicity and affordability go hand-in-hand.
Specialized vendors are in a good position to develop affordable eClinical systems by combining the revenue from multiple studies and multiple sponsors. By outsourcing to vendors, sponsors can avoid much of the heavy-lifting of deploying eClinical systems, and instead concentrate on integrating the systems into their trial management process.
KIS eClinical solutions must ramp-up within the two to three month time frame of a clinical trial start-up. That differs greatly from integrated eClinical systems that can take one to two years to develop. Rapid deployment requires that KIS eClinical systems are pre-built and flexible enough to support a range of study designs. Integration into existing sponsor IT infrastructure can be time-consuming, and it’s much faster to use software-as-a-service (SaaS) platforms that are already installed and up-and-running at a technology provider. SaaS systems are already functionally validated, saving months of time by corporate IT. Integral to the concept of rapid deployment is “rapid provisioning.” This requires systems that are easy to populate with study information by using import functions for user information, branding, study documents, alert, and training information.
Large integrated eClinical systems typically present study teams with platforms that are powerful, but not easily adaptable to the differing needs of individual trials. This “one-size-fits-all” approach can require designing the study around the capabilities of the system, instead of designing the system around the needs of the study.
The KIS eClinical approach varies the use of eClinical solutions depending on study needs, so that some areas of study operations may be automated, and others not. This requires eClinical platforms that can operate as stand-alone modules or work side-by-side with other systems. Special attention is needed in the design phase, so that eClinical systems are built with the flexibility to accommodate varying study needs.
One of the greatest challenges facing any eClinical system is the need to match the workflow of the clinical operation. Organizational differences, departmental variances, and protocol nuances all serve to undermine use of a one-size-fits-all workflow. KIS eClinical systems must be adaptable to account for these variations in workflow quickly and cost-effectively.
Medium and smaller players in clinical research tend to be more financially conservative than Big Pharma, with tighter budgets for individual trials. But rather than view eClinical as an extravagance, it’s important to keep sight of the substantial cost savings that many eClinical systems can yield.
A keep-it-simple approach starts with an assessment of the value of each eClinical option for each clinical trial. Using this value-based approach, study managers can select an appropriate mix of solutions, and deploy only as much eClinical support as is warranted. Depending on study scope and complexity, some study operations may not receive eClinical support, but rather employ traditional processes.
The value of eClinical systems is measured in avoided costs and labor of traditional processes, and by the avoidance of errors and delays arising from less precise processes such as paper-based systems. Value calculations can become highly technical and include valuations of queries, invalidated data, and other sources of inefficiency in clinical trials. It may be more practical for study managers simply to focus on areas of study operations that are known to be sources of error, are major components of the planned trial, and are amenable to quality improvement using eClinical solutions.
Value-based assessment is complex, and it may not be practical to conduct an ad hoc assessment for each study. A more sensible approach is to develop a standard tool for assessing each clinical trial and the value of eClinical support. These tools incorporate algorithms that compute value based on study variables and suggest an optimal mix of eClinical support.
Benefit all users
Most large integrated eClinical systems have been developed around user requirements set forth by clinical trial operations analysts and IT professionals, resulting in systems that work well for study managers but often don’t address the needs of end-users at study sites. This has naturally resulted in resistance among study sites that are tasked with using a myriad of eClinical systems across multiple studies. For eClinical systems to work well for study sites, they must be intuitive to use, require little or no training, and focus on tasks that study sites perform routinely. Most importantly, eClinical systems must make the completion of tasks by study sites easier, not harder, which has not always been the case.
To build eClinical systems around the needs of end-users, developers can borrow from the science of instructional design (ID), which is the process for systematically analyzing, developing, and delivering systems for target users. The ID process places primacy on user needs at the beginning, middle, and end of system development, including a final user evaluation step. A focus on the end-user may seem obvious, but end-user needs must be constantly reinforced during system development, or they may be obscured by the recurring demands of IT and study management.
Working with other systems
Perhaps the greatest benefit of an integrated eClinical system is that a central data set is used across various sub-systems, which streamlines data input, reduces data duplication and errors, and improves operational quality and efficiency in various ways. This is in contrast to the KIS eClinical approach outlined above, which describes the use of multiple stand-alone systems that focus on specific study needs.
It’s possible to achieve the power of integrated systems and the agility of the KIS approach by developing eClinical solutions that can both stand alone and work with each other. To do so, eClinical applications must be able to exchange data and work in harmony with a single data set. This can happen more easily if each platform is developed based on a common data standard. The Clinical Data Interchange Standards Consortium (CDISC) has guided the development of standards for clinical research data since 1997, and its CDASH V 1.1 standards are available for adoption. More than 250 biopharmaceutical, CRO, government, and technology organizations currently support CDISC. Other initiatives have been established within the research community to foster interoperability of electronic systems, such as SAFE Biopharm for digital identities, and the Metrics Champion Consortium development for standardized performance metrics. But despite these efforts, achieving ready integration among eClinical systems is a continuing challenge.
As data standards proliferate, interoperable eClinical platforms become more practical, and large integrated systems begin to lose their appeal. One advantage of interoperable platforms is that study sponsors can choose best-in-class platforms from among multiple service providers, instead of relying on a single service provider to be best-in-class across all areas of operation. This approach also allows drug developers to update to new technology for individual eClinical platforms without replacing the full array of eClinical systems.
A clinical trial ePortal can add significant eClinical value by serving as a hub for other eClinical systems. A trial ePortal can accept data feeds from other eClinical platforms and post key study metrics from multiple systems on a common dashboard, providing study team members with a current, consolidated view of study status. The ePortal can serve as a single point-of-access to other eClinical platforms, providing end users at study sites with a more convenient way to access and comply with all study systems. A trial ePortal can serve as a conduit for data streams from multiple eClinical platforms, and convert heterogeneous data feeds into a consolidated database. That can yield numerous advantages in administering study information and reporting consistent, unified data sets. A master ePortal can also serve as a foundational contributor to an eTrial master file.
eClinical systems must be developed and operated to the high quality standards of the clinical research industry, which means that technology platforms need to be fully validated and comply with regulatory standards across global regions, including ICH/GCP and FDA 21 CFR Part 11. Quality compliance, validation, and documentation can grow into costly aspects of eClinical systems, and a strict focus on KIS principles is needed to contain these costs. This can be achieved by designing and building systems that do not require a major cycle of re-validation for each use. KIS eClinical systems must be stable and built to last, with little or no re-design for next studies. Customers at drug developers need to resist the temptation to make design changes to eClinical platforms unless the changes are mission critical. Quality can also be streamlined by using vendor-hosted SaaS eClinical platforms that do not require installation and re-validation on sponsor’s servers.
Best in class vendors already have electronic systems that easily integrate into your current study workflow. “online site feasibility surveys” bring the benefits of speed and data accuracy with a minimal disruption to your recruitment efforts. “secure electronic document exchange” moves qualifying sites rapidly through the regulatory document process. “online training” that is done before and after the investigator meeting speeds timelines and simplifies oversight and record-keeping.
These systems are fairly low risk. You can run them in parallel with your older systems and still realize savings and speed without over-committing to an untried system. Essentially, you have them “out-compete” your current systems.
“Study alert” and “issues escalation” systems benefit greatly from the speed and tracking capabilities of on-line electronic systems. It’s easy to see how all these systems can find a common home on a dedicated study ePortal. In addition to vendors reporting their traditional metrics in the study ePortal, metrics can be combined from multiple vendors to give the same insights and sophisticated metrics that the enterprise-wide eClinical systems do. The ePortal can easily forward various vendor data into the SharePoint-based trial management systems that form the foundation for electronic trial master files (eTMF.)
Experience has shown that large eClinical systems, while attractive in theory, often fall short of expectations in practice. Complex IT systems often encounter unanticipated problems and are rarely developed within original budgets and timelines. Large systems are less adaptable to the changing needs of clinical research, and in an environment of rapidly-evolving regulatory requirements, large systems can even become outmoded before they are delivered and implemented.
As the biopharmaceutical industry evolves, the benefits of smaller, simpler eClinical systems may become attractive even to Big Pharma, especially as research programs re-organize from massive central operations into small autonomous research units. Big Pharma is also directing a larger share of its research capital into alliances, partnerships, spin-offs, and stand-alone acquisitions. In all these ways, Big Pharma is transforming its research structure from centralized organizations that support large-scale eClinical systems, towards small, independent research groups that may not have the funds or the patience to implement integrated eClinical solutions.
For the rest of us medium and smaller players, a single integrated system for all clinical operations is impractical. Instead we need to implement targeted eClinical systems that deliver exceptional time and cost savings, and that can provide actionable information faster. Until the day arrives when eClinical systems can be created by the end-user and tailored to meet the dynamic study needs—compliant, interoperable, validated, and ready-to-go on a moment’s notice—we will be faced with the need for a better way of doing business. It’s time we stop looking for an eClinical panacea, and instead implement simplified, interoperable systems that deliver clear value.
Bill Cooney founded MedPoint in 1990 in Evanston, Illinois. Since that time, Bill has presided over the growth and transformation of MedPoint. For more on MedPoint please visit www.medpt.com.
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