A to Z Trial Integration

The last mile in clinical research is integrating the research site to create a complete information supply chain.
Oct 01, 2007
By Applied Clinical Trials Editors

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There are significant opportunities to improve current methods of electronic data capture (EDC) in clinical research for both government and industry sponsored clinical trials. Current methods generally require investigators to keypunch data into EDC systems individually supplied by sponsors for each trial. While this is an improvement over paper-based methods, the current EDC model falls well short of possible efficiency improvements and, in effect, reinforces work redundancy at investigator sites.

A far more effective approach would be for clinical investigators and sponsors to share a common system platform or, at least, for systems at investigator sites to be capable of directly supplying high-quality, auditable clinical trial data to sponsors and be in compliance with CFR Part 11.

True integration

For some time now, forward-thinking investigators and sponsors alike have suggested that extracting clinical trial data directly from the electronic health record (EHR) would be far more efficient.

A thoughtful analysis of this opportunity, such as the March 2006 Applied Clinical Trials article "Integrating EHR with EDC: When Two Worlds Collide" by Paul Bleicher,1 rightly suggests skepticism about what's possible when EDC and EHR collide.

In short, integrating EHR and EDC is not viable today unless source EHR data is first fed into CFR Part 11 compliant systems for clinical trial fulfillment—which is exactly what some researchers have begun to do. The approach is conceptually straightforward: Use one system solution that at once addresses the needs of investigators and sponsors. Such systems and integrated supply chains are in production today, conducting trials electronically from source data to sponsor submission. The approach is very similar to supply chains commonly found in other industries such as manufacturing.

This article contains a description of how such fully integrated, clinical trial supply chains work from a systems perspective; the required systems technology; benefits for sponsors; supporting government and industry initiatives that are facilitating such integration; and some business model suggestions that will accelerate the evolution of integrated clinical research supply chains.

Last mile analogy

There is a need to solve "the last mile" problem in clinical research. The notion of the last mile is most often associated with the telecommunications industry, where wiring the last mile—the cable or phone lines that go from the street into the house—is among the most time-consuming and expensive system infrastructure challenges. Notably, in that industry such wiring is also necessary to deliver meaningful system value.

The analogy of the last mile also applies to clinical research, where the last mile problem is integrating research sites. Traditional EDC has gone part of the distance. To use the telecommunications analogy in the current model, investigators and their staffs using traditional EDC leave behind the systems and devices they use in their homes, walk to the bottom of their driveways or out to the sidewalk, log in to the system, enter trial data, and walk back into their homes and continue using whatever systems and devices they use on a day-to-day basis.

As such, clinical research fulfillment is a broken supply chain. Indeed, some would argue that the current state-of-the-art systems introduced increase workloads for many research sites, which in turn adversely impacts sponsor productivity and contributes to the extended time periods required to conduct clinical trials and obtain related drug/device approvals. Few would disagree that the current supply chain and EDC model likely perpetuates tens of millions of dollars annually in costs and delays in clinical research execution.

The only way to fix the supply chain is to solve the last mile problem. From an economic perspective, the constituency that stands to gain the most from a complete supply chain is research sponsors, particularly industry sponsors, simply because they generally have the most to gain economically from improved clinical trial execution. These gains in turn translate to better treatment options sooner for patients.

The system solution

The capabilities that need to be supported to enable an integrated supply chain include the following:

  • The ability to support investigator and sponsor clinical trial information through one system platform.
  • The ability to manage data across studies and patients without changing systems for each study.
  • Integration capabilities so that individual consortium members can have source clinical data feeds, such as lab and demographics, from internal source systems to the EDC solution and on to the sponsor.
  • The ability to broadcast clinical trials to investigators with otherwise uniquely configured research systems.
  • A fully compliant FDA CFR Part 11 system validated by industry sponsors.
  • A pure Internet platform solution that is flexible, highly configurable, and affordable.

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