Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
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ORIGINAL RESEARCH
Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View Abhijit A. Parab, MSc, MS1 · Prasann Mehta, MCA2 · Arundhati Vattikola, MS3 · Christine K. Denney, BS, CDMP, CDIP4 · Michele Cherry, BS5 · Rakesh M. Maniar, MS3 · Jesper Kjaer, MSc6 Received: 28 January 2020 / Accepted: 21 February 2020 © The Author(s) 2020
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. Keywords TransCelerate · eSource · Direct data capture (DDC) · Electronic health record (EHR) · Applications · Devices
1
Prasann Mehta [email protected]
Global Clinical Data Management and Central Monitoring, Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ 08543, USA
2
Arundhati Vattikola [email protected]
Global Data Management & Standards, Merck & Company Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA
3
Christine K. Denney [email protected]
Business Technology Services, One Health Plaza, East Hanover, Novartis, NJ 07936, USA
4
Michele Cherry [email protected]
Medicines Development IT, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
5
Rakesh M. Ma
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