Electronic Data Capture Systems for Breast Cancer Research

Abstract

Traditionally, clinical studies relied on collecting data by hands in paper case report forms (CRFs), which were later entered into an electronic database for statistical analysis. Clearly, this method was time-consuming, prone to misinterpretation, and basically inefficient. These limitations can be currently avoided using electronic data capture (EDC) systems, powerful tools reducing study times and costs and, importantly, enhancing the quality of collected data. Generally, EDC systems use a web-based platform, accessible from any computer or mobile device connected to the Internet. Investigators of a multicenter clinical trial can access the system at any time and at any location, with only the possibility to enter patient data of their own center, being blinded to the other institutions’ data. The administrator has total access to all subjects enrolled by all centers, exclusive rights to extract patient data, and the ability to modify the content of any CRF at any time. EDC systems are still poorly used in breast imaging research and imaging research in general, as handling of images is still insufficiently supported. In this chapter, we provide an overview of the current information technology systems to gather data in the framework of a multicenter clinical trial. A working example is discussed in the specific setting of the use of magnetic resonance imaging (MRI) for breast cancer screening of high-risk women. In addition, the experience of a large international study on preoperative breast MRI is reported. Radiologists and imaging specialists, especially when carrying out spontaneous and/or low-budget research, should be aware of the possibilities offered by these systems.