STRATEGIC INSIGHTS Clinical Trials
Implementation by clinical sites is lumbering along at an unimpressive rate. Here's what must be done to speed things up
By Nicholas Richards
March 17, 2004 | What's hobbling adoption of electronic data capture (EDC) technology in the biopharmaceutical industry?
This is the multibillion-dollar question. Countless EDC pilots have been abandoned. Sponsors complain about the process change required to move from paper-based data capture systems to electronic methods. But the biggest hurdle to EDC adoption and the realization of its benefits — in my experience with top pharmaceutical companies and government entities — is lack of integration.
For years, the pharmaceutical industry has been building proprietary systems and adapting a variety of commercially available systems for data collection, data management, project management, adverse event reporting, and other business activities. Historically, these solutions have been proprietary in nature, therefore inhibiting the flow of data from system to system and forming the all-too-familiar "islands of information" that result in duplicate data entry, inefficiency, and poor decision making without the right combination of information at the right time.
Integration is a serious hurdle that will ultimately require industrywide adoption of open technology architectures and industry standards, such as those promulgated by the Clinical Data Interchange Standards Consortium (CDISC) and HL7, to allow for data exchange between disparate systems. This is the most important step the industry can take in order to break down technology barriers and improve the drug development process.
Process Management Shift
Open technology architectures fall into one of two main camps: Unix/Linux operating systems running Java-based applications developed in a J2EE environment, versus Microsoft Windows operating systems running .NET-based applications developed in the Microsoft .NET Framework. Unix/Java has long been the standard for mission-critical applications but has seen a loss of market share due to aggressive pricing and greatly improved products pouring out of Microsoft. The company's new Enterprise Edition of BizTalk 2004, for example, comes in at an affordable $25,000 and packs a strong set of features, while competitors' products in the integration-software arena can run more than $500,000.
TIES THAT BIND: Collection of clinical trial data feeds a number of processes and applications. Open architecture and industry standards (in green) serve as the common glue to connect disparate systems. |
Regardless of the technology architecture, however, it's critical that software vendors support a common set of interoperability tools such as Web services and XML. This means a robust set of Web services that can provide access to a majority of the system functionality, not merely one Web service that simply allows export of clinical data. The collection of clinical data should automatically update other systems (such as project management) and trigger processes such as safety reporting, grant payments, and supplies management. A myopic focus on the collection and management of clinical data alone will limit the tremendous efficiencies that can be achieved with the technology.
To truly affect the bottom line in drug development, though, EDC vendors must advance the sophistication of their solutions to handle complex process management issues that surround the collection of data. New standards must be brought to bear, such as BPML (business process modeling language), which uses XML to route data in a predefined workflow. This shift to a process-management or information supply-chain mentality cannot be stressed enough because without it, those on the front lines won't have the tools to support the process change so desperately needed within the biopharmaceutical industry.
Significant headway has been made on industry standards governing the storage and exchange of clinical data with the formation of CDISC and collaboration with other standards groups such as HL7 in the healthcare arena. Software vendors must support these standards wholeheartedly — not just pay them lip service. The ability to import/export clinical data in a CDISC structure should not involve a $100,000 consulting engagement or an added line item to the services agreement.
Software vendors also need to provide an acquisition model that supports integration activities and the ability to affordably scale the solution. Most EDC offerings available today are based on a service model rather than a software sales model, which makes integration and scalability difficult and costly.
The current service model for EDC reflects the biopharmaceutical industry's initial reluctance to buy unproven software, and its comfort with contracted services popularized by contract research organizations (CROs). But because service providers generally aren't organized to efficiently sell and support software, the cost of ownership of a model based on contracting for services on a study-by-study basis is often prohibitive.
Under the service model, the costs for an individual study typically involve technology transfer (use of software), the services required to set up and administer the study, training costs, costs for hardware and server software, and length of time it takes to set up a study. If an average study costs approximately $300,000, conducting only 25 studies using this model would cost $7.5 million! This approach is simply not viable for large companies that would conduct the majority of their studies using EDC.
If service providers can't deliver the required level of integration and adaptability, higher costs from lack of integration and poor flexibility will be the implementation's downfall. Software solutions that can be purchased as commercially available products will provide customers greater flexibility and foster a more vibrant developer/user community.
While software vendors will carry much of the responsibility for advancing EDC through open architectures, industry standards, and cost-effective acquisition models, the software industry cannot champion the cause alone. Trial sponsors (i.e., biopharmaceutical companies) must play a role in advancing the technology.
Business and technology decision makers must demand new software that can easily adapt to established business processes and integrate with legacy systems. The good news is, technology companies are beginning to embrace open standards on their own, providing the platform for software that's flexible enough to adapt to the peculiar and special ways that sponsors work. The ability to build upon EDC software and adapt to changes in business processes will allow the industry to embrace standards and realize tremendous cost and time savings.
Trial sponsors won't realize the true financial benefits of EDC, however, until solutions emerge that can effectively integrate with the numerous systems involved in the clinical development process. And without significant returns on the technology investment, the adoption of EDC will continue to lumber along at an unimpressive rate.
The industry is primed for a new generation of solutions that can serve as the cornerstone of the clinical development process and help capitalize on existing technology investments. These solutions must be built on a foundation of open architectures and industry standards, and the technology should offer enough flexibility to meet the growing needs of the industry.
If the biopharmaceutical industry fails to recognize this problem and continues to foster the construction of proprietary technology fiefdoms, it's destined to suffer the fate of those who have tried to profit from re-inventing the wheel.
Nicholas Richards is vice president of product development for DataLabs, a developer of clinical trial automation software. E-mail: nrichards@datalabs.com.
PHOTO OF CHAINED PDA BY: MARK A. GABRENYA