Tools Are Just the Beginning

Should companies wait for fully integrated systems?
Jun 01, 2005

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?

A single clinical development system would allow data to flow smoothly among various functions.
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 the mix.

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).

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