Unlike traditional document-based clinical trials, new clinical trial protocols that feature medical images add a layer of complexity associated with the uniform acquisition, management, reading, and subsequent audit and storage of patient images primarily for regulatory, research or adverse event purposes. These new requirements should be taken into consideration to allow time for pharmas and CROs to plan for the necessary upgrades to their front-end applications and back-end infrastructures.

This article will examine the impact that the inclusion of images in clinical trials will have on trial study acquisition; study workflow, reading, and submission; and data management, archiving, and protection. It will also present some recommendations that organizations can undertake today to minimize the impact that the addition of images will have on their existing applications and infrastructures.

To understand the kind of impact that the shift from documents to digital images can have on an organization's IT systems, it is not necessary to look far: One can easily be found in the shift that took place earlier this decade in the health care industry. With increasing pressure from the government and health insurance companies to improve patient outcomes, and pressure from shareholders to improve business results, many hospitals started to modernize their clinical IT systems in the late 1990s.

The first shift involved moving to integrated hospital information systems that enabled physicians and administrators to manage the flow of patients (admission, treatment, discharge, and billing) more effectively and at a lower cost. A second, more recent, and significant shift has been the aggressive move from film-based medical imaging (remember the film based x-rays that you had to carry around from doctor to doctor?) to newer digital information systems and picture archiving and communication systems (PACS) that enable those images to be digitized, shared, and over time included into an electronic medical record (a single, secure, and shareable view of a patient's medical profile).

The implementation of these PACS systems has been very rapid, with adoption rates that were in the teens just five years ago rocketing to 80% in the United States and Canada today.

This rapid shift to digital from document-based systems, however, was not met with an accompanying upgrade of the existing workflow and data management infrastructure. First, the addition of images that can be 10 to 30 times larger than documents put a massive strain on the storage systems installed at most hospitals. Second, since these images were no longer available in physical form, hospitals were forced to share or replicate these images across locations, thereby straining the hospital's network and middleware infrastructure. Third, significantly easier access to patient images caused clinicians and doctors to ask for more information (e.g., earlier patient studies or newer views of data) across multiple locations, thereby compounding the problem.

Figure 1. Three independent but integrated architectural layers

Image-enabled clinical trials infrastructure

When designing a robust and scalable image-enabled trial infrastructure, it is helpful to understand the different architectural layers and their respective functions. Figure 1 shows such an architecture and describes an image-enabled clinical architecture consisting of three independent but integrated layers:

• the application layer
• the image management layer
• the storage management layer.