Imaging in Clinical Trials

Historically, the use of imaging in clinical trials took a back seat to other forms of data. Today, it has become a powerful tool in clinical trials with its ability to enable rapid diagnosis with visualization and quantitative assessment. Xrayfilm_site3_1.jpgIts growth in the last decade is primarily due to technology advancements and FDA's increasing insistence on the use of imaging. In addition, the sponsors have seen the value of imaging, especially in early stage development helping to make early go/no-go decisions and thereby deriving substantial savings.

However, vendors are still behind the curve in adopting the latest technologies and optimizing the value that can be derived in fully integrating imaging into clinical trials. Electronic Data Capture (EDC) vendors continue to focus on providing solutions which have limited functionality for managing images. Contract Research Organizations (CRO) and Imaging Corelabs are geared to providing turnkey outsourcing solutions using proprietary technologies where the sponsor has little transparency or control during the trial. This situation today has resulted in the sponsor bearing substantial and unnecessary cost in getting the data together from disparate systems for final submissions.

Unlike traditional data-centric clinical trials, imaging- based clinical trials require substantially different solutions that can address uniform acquisition, management, analysis, audit, and storage of images primarily for meeting regulatory and research purposes.

Industry Trends

We believe the ideal goal of a sponsor is to retain control during the entire trial process, have visibility of the data in real time, make course corrections, and go/no go decision during the trial. In addition, their objective has to be to unify all the DICOM and NON-DICOM trial data in a standardized format, increase the quality of data and expedite the final submissions. We believe the trend willa-medical-madoff-anesthestesiologist-faked-data_1_0.jpg be towards using EDC and imaging solutions to provide control to the sponsors and enable easy integration of various technologies that support common data standards.

We also believe imaging biomarkers and surrogate endpoints will find increasing use in clinical trials as they need a smaller number of patients, deliver quicker reults and thereby reduce costs and timelines. Trials that rely solely on clinical endpoints are very costly as they have long durations and tend to need a large number of patients. In contrast to clinical endpoints, surrogate endpoints have been shown to cut down the time required to confirm whether a drug has clinical benefits.

aw_workstation_tab_0.jpg Cloud and open standard web-based solutions will be in ever increasing demand as they have been designed to meet the current needs of the sponsors. Cloud computing provides convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction. Cloud computing promotes availability and is composed of three service models:

  • Software as a Service (SaaS)-Uses the provider’s applications over a network
  • Platform as a Service (PaaS)- Deploys customer-created applications to a cloud
  • Infrastructure as a Service (IaaS)- Rents processing, storage, network capacity, and other fundamental computing resources

The SaaS software is deployed over the Internet or behind a firewall on a local area network. The vendor typically provides a license to use an application either as a service on demand through a subscription, or in a "pay-as-you-go" model. It is part of the utility computing model where all of the technology is in the "cloud" accessed over the Internet as a service.