Optimizing the Use of Electronic Data Sources in Clinical Trials: The Technology Landscape.

TransCelerate has created an initiative to facilitate the industry's movement toward optimal use of electronic data sources for clinical research. Although guidance and standards have been in place for some time, gaps remain. Consequently, transcription among electronic systems continues to be the norm. In the initial phase of the eSource Initiative, TransCelerate is developing a thorough understanding of the current landscape. As a preliminary step in this process, the TransCelerate eSource Initiative published Optimizing the Use of Electronic Data Sources in Clinical Trials: The Landscape Part I, which provided insight into sponsor company eSource activities and the environment affecting eSource adoption based on input from TransCelerate member companies, standards organizations, and regulatory authorities. For Part II (this article), TransCelerate surveyed technology companies, including CROs providing technology, to better understand capabilities available today, plans for eSource, and perceived barriers to greater adoption. This information is a vital input that will help shape upcoming TransCelerate proposals for best practices for industry utilization of electronic data collection tools and methods. It is clear from the survey results that the technologies needed to support the various eSource modalities are mature. However, the approach to implementing eSource is fragmented. Greater collaboration is needed not only within the pharmaceutical industry but across industries that include health care and technology. The industry must reach common understandings about novel endpoints, data standards, system validation, and related issues. While technology in itself is not a significant barrier to eSource implementation, interoperability among systems is an enormous challenge to establishing a complete end-to-end electronic health care and research ecosystem. The TransCelerate eSource Initiative will continue to evaluate the technology, regulatory environment, data standards, and health care landscape to support the goal of improving global clinical science and global clinical trial execution. Forthcoming publications will focus on future vision and demonstration projects.

Optimizing the Use of Electronic Data Sources in Clinical Trials: The Landscape, Part 1.

BACKGROUND: TransCelerate BioPharma has created the eSource Initiative with the intent to facilitate the industry's movement toward optimal usage of electronic data sources. Although guidance and standards have been in place for some time, data collection methods and technology have not been utilized to their fullest capability, and transcription between electronic systems continues to be the norm. METHODS: The TransCelerate approach for the eSource Initiative is to understand the current landscape and highlight factors that are influencing the adoption of new technologies. As a preliminary step in this process, TransCelerate surveyed member companies regarding eSource usage and barriers. RESULTS: Literature review, stakeholder engagement, and the member survey have provided insight into the current landscape, which will help TransCelerate to develop proposals for best practices for industry utilization of electronic data collection tools and methods to benefit all stakeholders. CONCLUSIONS: Based on survey results, companies generally have taken steps to leverage current eSource technologies and prepare for optimal utilization of electronic data sources. The TransCelerate eSource Initiative will continue to evaluate the technology, regulatory, standards, and health care landscape to support the goal of improving global clinical science and global clinical trial execution. Forthcoming publications will focus on technology landscape, future vision, and demonstration projects.