March 10, 2003
| LAST YEAR the FDA approved only 17 new molecular entities (NMEs), marking the lowest rate of new drug approvals in nearly 20 years. Explanations for the sharp decline range from dry pipelines and fewer new-drug applications to longer FDA reviews. While there's little doubt that these factors contributed to the drop-down from 24 approvals in 2001 and a peak of 120 approvals in 1996, they are part of a larger issue confronting clinical development: a productivity crisis.
Drug companies face tremendous pressure to improve their pipelines and test, approve, and market more new drugs. Within the next five years, 35 blockbuster drugs will lose their U.S. patent protections. According to market research firm Datamonitor (Global Generics Guide, August 2002), these drugs represent more than $70 billion in global sales. Further, the promise of new biological drugs, as the result of genomic and proteomic research, will spur a major industry migration from traditional mass-market drugs to individualized or targeted treatment therapies based on cutting-edge biotechnology.
|It's a Multi-App World
|Individual vendors may promise total integration, but the market and technology trends listed below should remind companies that their clinical development infrastructure needs to support multiple applications.
>> Some of the more than 50 electronic data capture (EDC) vendors will leave the clinical development business; others, perhaps with architectures that support the latest connectivity and standards definitions, will emerge.
>> Multiple trial requirements and multiple geography requirements may dictate use of different data-capture technologies across an organization.
>> Technologies currently being tested in pilot trials, such as handheld devices, will eventually become part of the standard infrastructure.
>> Always-connected, wearable monitoring technology will become mainstream.
>> Electronic medical records and related systems and standards will emerge.
These pressures, and escalating R&D costs, are prompting the industry to embrace information technology as a means of bringing new efficiencies to drug discovery and development — from isolating new compounds to clinical trials and FDA filings. Clinical trial automation, in particular, can play a key role in reducing drug development costs. Let's examine how clinical trial technology, explicitly supporting overall business strategies, can increase the productivity of the clinical development process.
Using information technology to enable clinical trials means different things to different people, which itself implies the need for an organizational plan that defines the business and IT strategy for clinical development. But at its most basic, clinical-trial IT typically refers to integrating and deploying an infrastructure that gives users easy access to applications, productivity tools, and accurate data from wherever they are working. As examples in other industries show, IT can help drive necessary change and, of course, ease the process improvement required to increase clinical development productivity.
So far, however, there's no de facto standard or ERP-like application for clinical development. The clinical IT environment is extraordinarily complex, consisting of multiple "functionally focused" applications. Some of these applications have become industry standard in their respective areas of focus, but none fulfill all the functional requirements of clinical development.
Many applications currently in use have evolved over time, their main characteristics often including: they were developed in-house; use superseded, inflexible technology; focus on the business requirements of paper-based processing and data handling; lack user (e.g., investigator) focus and support for today's cooperative work environments; and are not "e-enabled."
Despite these shortcomings, homegrown clinical development software frequently becomes further entrenched with hardwired integration and reporting processes. Hence there's often significant resistance to change. Yet change can and will happen, provided the new technology being offered truly delivers greater process efficiencies and throughput. Such IT will successfully address the following five areas:
- Availability of data (electronic data capture [EDC] should be pervasive)
- Access to data and applications (systems should be e-enabled)
- Integration of applications and data (systems should be easily integrated)
- Flexibility to adopt new technology (it should be easy to retire and introduce new applications and technologies)
- Intuitive user environment (users should have a single point of access to applications).
The issue of data availability has become increasingly important, thanks to EDC technology. Initially perceived as a means to improve the effectiveness of the clinical data-capture process, EDC has recently assumed a more critical role of providing near-real-time data. It's therefore a prerequisite for almost all other clinical development initiatives — especially those related to the more iterative and data-intense drug development paradigm of the future.
|Core Applications for Clinical Development
|Aligned with the business strategy and supported by a high-bandwidth connectivity backbone and a scalable integration framework, the application portfolio of leading drug companies typically includes tools for:
- Investigator relationship management
- Clinical data management
- Clinical trial management
- Adverse event management
- Coding system
- Document management
- Electronic data capture
- Patient diaries
- Project and portfolio management
- Laboratory data systems
- Statistical analysis and reporting
- Resource management
As for access to data and applications, industries in general continue to benefit from e-business technology, and clinical trials are no exception. The e-enabling of clinical development can increase the flexibility of the organization and staff by enabling mobile work. If an e-business infrastructure is already in place for internal personnel, it's a small step to make it available to others in the clinical development supply chain, such as investigators, clinical research organizations, and regulatory agencies.
The tight and relatively straightforward integration of systems is essential to maximizing productivity because it eliminates duplicate data entry and reconciliation work — particularly important as data begins flowing in near-real time. Likewise, an environment as dynamic as clinical trials demands that companies be able to easily retire old applications and bring in new ones without difficult integration, training, or process upheaval.
Finally, perhaps the most important productivity strategy is to give clinical development professionals a single point of access to the applications, data, and tools they need to do their jobs faster and more effectively. One model for this access is a portal-type "clinical development workbench" (see "Portal Workbenches," below). Such a workbench would provide access to collaboration tools, for example, that enable teamwork across functional silos, encouraging information sharing and improving interaction and reporting with external partners. It may also include visualization tools that facilitate effective use of near-real-time data available to clinical development teams.
Mapping an Implementation Strategy
Clear benefits of clinical IT notwithstanding, the drug industry has been slow to adopt needed technology. Each year, more than 80,000 clinical trials are conducted in the United States, and about 95 percent of these are still paper-based. Moreover, multiple "isolated" systems are used for capturing clinical data in case report forms, producing investigator visit reports, and managing trial progress and payments, not to mention providing trial supplies. This approach not only extends the overall trial process by months but also leaves drug companies vulnerable to process flaws that can go unnoticed for months, too.
This bodes well for EDC technology to become increasingly pervasive. The availability of near-real-time data resulting from broad adoption of EDC will be a catalyst for change in clinical development, helping to accelerate trials and approvals, and eliminating unsuccessful trials earlier.
|It goes by different names, but the concept of software "workbenches" for clinical development is becoming generally accepted by drug companies as a way to boost productivity without disrupting the existing application portfolio. A workbench lays the foundation for collaboration among players in a clinical trial, and it enables subsequent incremental change of individual applications with minimal user upset.
Simply put, a workbench is a network portal built around Internet standards that provides a single point of access to all applications and tools used in the clinical development process. Depending on company-specific requirements, a workbench is likely to include:
- A reporting tool, allowing integrated access to information from multiple applications
- A customizable interface, reflecting user-specific information priorities
- A single log-on, shielding the user from the complexity of the underlying infrastructure
- Integration with desktop productivity tools, such as e-mail and messaging, for improved collaboration and knowledge sharing
Perhaps most important, from a user-acceptance standpoint, the workbench sits "above" existing applications, so there's minimal impact on established processes and little risk to applications. The workbench approach doesn't change the underlying software.
A company considering EDC, however, should take a more holistic look at clinical development automation. Successfully implementing any technology that affects clinical development will rely on an IT strategy that has:
- Identified how Web technologies can benefit the organization's business model
- Identified gaps in the current IT portfolio
- Identified initiatives to generate the missing capability and provide a return on investment
- Drawn a road map of prioritized initiatives
- Developed an integrated strategy to optimize the benefits of existing technologies and reduce the complexity of an increasingly global clinical trial environment
Among the first areas this IT strategy should examine is the appropriate network for an e-enabled clinical development environment, including the pervasive use of EDC. After all, the best e-enabled applications in the world aren't much use if the core infrastructure cannot support information and application sharing and collaboration among users — company employees as well as offsite users such as investigators and clinical research organizations.
Broad bandwidth capability should be implemented, along with effective security to meet corporate and regulatory requirements without sacrificing performance. The cost benefit of building a robust and secure intranet, however, is that it enables the globalization of clinical development applications. In some cases, a single global implementation, rather than multiple regional implementations, may meet business needs and bring accompanying savings in support, maintenance, and data standardization.
The next area to investigate is systems integration, where the benefit of deploying EDC will be lost if near-real-time data capability cannot be exploited. For example, significant operational benefits are possible when systems for clinical trial management, clinical data management, and investigator information management can all be updated and synchronized in near-real time. Conversely, standalone systems foster redundant data and operations that severely tax resources.
True data integration is the goal of industry groups such as the Clinical Data Interchange Standards Consortium (CDISC), as well as from the integrated data environments being offered by a number of vendors. Though these systems are still emerging, they're likely to offer significant opportunity to early adopters.
Companies should also evaluate systems based on the ease with which they can plug in different applications as circumstances dictate. If changing EDC systems involves a lot of work, the tendency will be to stay with the current system — even when other EDC technologies and vendors are more suitable for certain studies. An integration framework that enables the easy switching of applications overcomes this inertia and allows the IT infrastructure to remain current and support the business in the best ways possible. Furthermore, the availability of established technology services in an "on-demand" model may be the most flexible, allowing companies to choose and use applications as needs and technology evolve.
Before clinical trial automation can become the rule rather than the exception, however, individual companies as well as the industry at large must address several technical and organizational challenges, including limited systems integration, a lack of standards, and resistance to change. Only then will companies achieve significant operational benefits by using the current technology. And only then will they position themselves strategically for the clinical trials and data-driven drug development environments of the future.
Colin Spink is a life science IT specialist with IBM Business Consulting Services. He may be reached at email@example.com.
Sven Blumenstiel is a pharmaceutical solutions specialist with IBM Business Consulting Services. He may be reached at firstname.lastname@example.org.