ABSTRACT
For almost a decade, regulators and pharmaceutical industry groups have been interested in electronic source (eSource) in clinical trials (Nordo et al. in Learn Health Syst 3:e10076, 2019). eSource may provide efficiencies and value; however, eSource adoption is fragmented and slow. Acceleration of eSource adoption is a critical step in modernizing the conduct of clinical trials. The desired future state is one in which all source data, acquired through any context (e.g., healthcare delivery, chronic disease management) and actor (e.g., healthcare professional, patient, caregiver), are completely electronic, adequate in quality, and fully acceptable in clinical trial submissions by regulators worldwide. Achieving this desired future state requires transformative change management to foster adoption and minimize the burden of implementing eSource. Realizing this vision requires collaborative and dedicated efforts from multiple stakeholders, including patients, clinical trial participants, sites, technology vendors, standards organizations, regulators, payers, and sponsors. Stakeholders should align upon guidance to promote data integrity, data privacy, data security, and interoperability. The eSource revolution requires open dialogue, inclusive of shared learnings among stakeholders, to collectively and rapidly advance adoption. Adoption of eSource will optimize clinical research by enabling faster access to research data and more rapid decision-making, increasing clinical trial efficiency. Furthermore, adoption of eSource will improve data integrity by allowing direct data flow from the source to the sponsor's system, with minimal or no human intervention. This paper provides the TransCelerate point of view (POV) and recommendations to achieve the future state vision of complete utilization of eSource data in clinical trials and builds on previous TransCelerate eSource publications.
Subject(s)
Drug Industry , Clinical Trials as Topic , HumansABSTRACT
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.
