The pharmaceutical industry has entered the "enterprise era" of electronic technologies for clinical development. While 70
to 80 percent of clinical trials are still paper based, many of the largest pharma companies have committed to doing virtually
all their clinical trials using electronic data capture (EDC). Technologies for collecting and mining safety data are being
heavily adopted as FDA and the public demand better, faster access to safety data. And industry stakeholders are developing
a growing appreciation for the way electronic tools contribute to higher data quality, faster and more effective access, greater
cost effectiveness, and shorter clinical development timelines.
These tools, of course, are just the beginning. The industry is accelerating adoption of many additional technologies, including
integrated trial management systems (ITMS), communication portals, and many other solutions that address clinical development
workflows. In the pilot phase are automated authoring of protocols, clinical trial simulations, electronic informed consents,
electronic institutional review board (IRB) processes, and electronic budgeting and payment systems. Ideally, these functions
and others will be integrated into a single clinical development system, allowing data to flow smoothly among them, facilitating
better decision making, and optimizing study results. (See "The Emerging Value Chain".) But for the moment, most are stand-alone
"point solutions," or at best, partially integrated. Companies are faced with a strategic question: Should they adopt these
technologies as they exist today, or wait for the development of a fully integrated clinical development system?
Integrating Value Chains
To date, no pharmaceutical company has been able to create a fully automated clinical development process. The integrated
software necessary is not yet available, and no companies have achieved the standards, process knowledge, and commitment needed.
On the other hand, the industry has evolved to the stage where electronic solutions are an accepted—even expected—part of
A single clinical development system would allow data to flow smoothly among various functions.
Today's e-clinical tools tend to be stand-alone systems. But they are gradually integrating a number of related processes,
from protocol development, site initiation, and subject enrollment to data collection, monitoring, analysis, and regulatory
submission. Companies such as GlaxoSmithKline, Schering-Plough, Eli Lilly, Novartis, Bayer, Procter & Gamble, and others have
openly discussed the value they aim to achieve with electronic data capture. Almost every company using such EDC systems hopes
to integrate them with software that controls other parts of the development process.
Some within the industry suggest forgoing upgrades of individual technologies as they wait for a unified e-clinical system
that will manage all functions of clinical development. Whether they are considering an enormous project within their organizations
or a giant consulting assignment to systems integration specialists, they should be aware that this road is littered with
spectacular failures. The Federal Bureau of Investigation paid more than $113 million for software meant to unify its case
management process. Reportedly, the software delivered was outdated and will only be used to help design a completely new
system. This story echoes in the halls of major pharmaceutical companies as well.
Smart sponsors and contract research organizations (CROs) are not waiting for a finished e-clinical system. Instead, they
are moving ahead by incorporating one or more integrated electronic solutions to improve the clinical trials process, today.
The first and key step is automating the painful paper process of data collection between sites and sponsors. The supply chain
methodology used in manufacturing has important lessons for clinical development in the "manufacture" of its key product—the
new drug application (NDA) or biologic license application (BLA).