Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective
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ORIGINAL ARTICLES
Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective Donald G. Jennings, MS, MBA1 · Amy Nordo, MMCi, RN/BSN, CPHQ2 · Aruna Vattikola, MS, MBA3 · Jesper Kjaer, MSc4 Received: 15 August 2019 / Accepted: 10 February 2020 / Published online: 11 March 2020 © TransCelerate Biopharma Inc. 2020
Abstract Background The technological complexities and broad operational scope of eSource impede coordinated, inter-organizational action on advancing at-scale solutions. Methods We introduce an architectural framework for articulating technological considerations across organizations. The architecture neither implies nor endorses solution implementations; rather, it proposes solution functionality based upon principles and good clinical practices. Results Key technology considerations include patterns of anticipated use, implications to the current state of clinical trial operations, and the need for new technologies (i.e., IoT, Big Data, Predictive Analytics). Conclusion Technology considerations drive implications beyond technology—influencing regulatory, process, and ethical realms of clinical research. Keywords Architecture · Digital · TransCelerate · IoT · Big data · Analytics
Background Adoption of digital technologies into clinical research simultaneously disrupts and transforms how pharmaceutical companies (Sponsors) approach development of new therapies. It drives innovation, provides for planning and execution of higher value trials, drives discovery of correlations between digital signals and biological events, and has the potential to personalize therapeutic health outcomes. Technology professionals should understand how digital methodologies disrupt current clinical research models and respond with solutions that address the new needs while simultaneously supporting global regulatory expectations, data integrity, and security and privacy concerns.
* Donald G. Jennings [email protected] 1
Digital Health, Eli Lilly and Company, MC/525/02, Indianapolis, IN 46285, USA
2
Clinical Trials Solutions Pfizer, Inc., Groton, CT, USA
3
Novartis Business Technology Services, East Hanover, NJ, USA
4
Novo Nordisk A/S, Bagsværd, Denmark
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eSource is the digital vanguard of clinical research. Simply stated, eSource is data initially recorded in electronic format [1]. Since 2010, many regulatory authorities have either expressed interest in, or provided written guidance on, their expectations for use of eSource in clinical trials [1–5]. eSource is a timely topic, but the disruptions and associated technological implications have not been widely discussed. eSource brings four significant technology disruptions into the clinical research domain. • It moves clinical research into the realm of Big Data—
with potential data volumes that far surpass those associated with main-line clinical trials. • It builds an interoperability bridge with the Healthcare IT domain, allowing Sponsors to coordinate trial data with electronic health recor
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