Development of common data elements: the experience of and recommendations from the early detection research network

Abstract

There have been an increasing number of large research consortia in recent years funded by the National Cancer Institute (NCI) to facilitate multi-disciplinary, multi-institutional cancer research. Some of these consortia have central data collection plans similar to a multi-center clinical trial whereas others plan to store data locally and pool or share the data at a later date. Regardless of the goal of the consortium, there is a need to standardize the way certain data are collected and stored, transferred, or reported across the institutions involved. This communication is a report of the process and current status of the development of common data elements (CDEs) by the Early Detection Research Network (EDRN). The development of the CDEs involved several stages with each stage requiring input from multi-disciplinary experts in oncology, epidemiology, biostatistics, pathology, informatics, and study coordination. An effort was made to be consistent with other consortia developing similar CDEs and to follow data standards when available. Initial focus was on identifying the minimum data that would be necessary to collect on all EDRN study participants and EDRN specimens. There are currently CDEs in the development or pilot phase for eight different organ sites and 13 different types of specimen procurements and plans to develop CDEs for 12 or more additional types of specimens.