These recent developments are just the most important among many regulatory developments that encourage the adoption of ECD
and related systems in the pharmaceutical industry. Eventually, the electronic submission requirements will become so pervasive
that they create a competitive threat for companies whose enterprise technology does not meet the reporting challenge.
The (Gradual) Road Ahead
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A Look at the Future
Many pharmaceutical companies long ago implemented an enterprise resource planning (ERP) system on the business side. The
ERP system often dovetails with the clinical side, if only at familiar points like the hiring and payment of contract workers,
the procurement of basic medical supplies, and standardization of contracts, liability agreements, and so on.
To proceed down the road to fully electronic clinical development, systems must incorporate more elements of the clinical
data core into one system that supports business and clinical decisions at the same time. For example, benchmarking the activities
of external vendors and investigative sites with respect to quality, enrollment and efficiency of previous trials would improve
the selection of outsourcing partners, such as CROs.
Tiered project management of operational activities, data, and documents The backbone of a future clinical ERP system is likely to be an intranet-based roadmap that contains the plans for a complete
NDA or BLA. For every new project, the system would create the outline of the NDA and have placeholders for the documents
and decisions that are needed at various stages in the clinical development process. As the process unfolds, the system indexes
and cross references all documents, including versioning, background, discussion, and data for pre-clinical and clinical steps.
The process of drug development itself is performed through the software, not documented by it. Eventually, the ERP also might
serve as a management tool for creating a general development plan for investigative compounds or devices.
Real-time analytics Businesses, including pharmaceutical companies, use real-time data to spot trends and improve operations. As investigative
sites collect more and more electronic data, such real-time analytics (RTA) promise to shape best practices on the clinical
side. Researchers who review data in real-time can not only detect disturbing patterns such as clusters of adverse events,
they can also modify the design of a study in midstream. When incorporated into study designs and analysis plans, adaptive
randomization allows the size, randomization schema, and other study parameters to be adjusted based upon pre-defined parameters
of the data, provided data are collected in near real-time, such as in an EDC system.
Content management throughout the NDA process Multimedia and Internet companies use enterprise content management (ECM) to archive and recycle bits and pieces of information
in the production of Web sites, e-learning, and other media products. The NDA is a promising target application for ECM.
Most pharmaceutical companies have adopted some type of ECM to keep track of the immense flow of documents in an NDA, but
such information is seldom shared across the larger clinical enterprise. Tools developed for searching/ indexing content and
managing digital rights can be adapted easily to the NDA or BLA environment. Much of the content used in NDA reports is repeated,
more or less verbatim, in dozens of different places. Clinical protocol language is similarly reused repeatedly. ECM makes
it possible to create content libraries full of passages that can be recycled over and over. ECM libraries also can be used
for automated protocol development and other report writing.
New possibilities will emerge as automated reporting, electronic medical records, EDC, and automated alerts of serious adverse
events begin to interact. (See "The Role of EMR".) But progress toward more sophisticated ECM and ERP systems is sure to
remain gradual.
The completely integrated, fully electronic clinical development system will not just appear one day, completely formed. (See
"The (Gradual) Road Ahead.") Instead, expect the continued improvement of existing point solutions, and eventually, the integration
of these solutions. Overall development will be driven by the value of each individual solution. Pharmaceutical companies
that are first to put electronic clinical development solutions online are likely to be first to integrate their systems—and
first to reap rewards from an improved value chain.
Paul Bleicher, MD, PhD is chairman and founder of Phase Forward. He can be reached at
paul.bleicher@phaseforward.com
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