JMIR Publications

ABSTRACT

Background:

Electronic sources (eSources) consist of data that were initially documented in an electronic structure. Typically, an eSource encompasses the direct acquisition, compilation, and retention of electronic information (such as electronic health records (EHRs) or wearable devices), which serves to streamline clinical research. eSources have the potential to enhance the accuracy of data, promote patient safety, and minimize expenses associated with clinical trials. An opinion study published in 2020 by TransCelerate outlined a roadmap for the future application of eSource technology and identified five key areas of challenges. The background of this study concerns the utilization of eSource technology in clinical research.

Objective:

The purpose of this study is to present challenges and possible solutions regarding the implementation of eSource technology in real-world studies (RWSs) by summarizing team experiences and lessons learned from an eSource record (ESR) project.

Methods:

After initially developing a simple prototype of the ESR software that can be demonstrated systematically, the researchers conducted in-depth interviews and exchanges with different stakeholders to obtain guidance and suggestions. The researchers selected 5 different roles for interviewees: regulatory authorities, pharmaceutical company representatives, hospital information department employees, medical system providers and clinicians.

Results:

After screening all consultants, the researchers concluded that there were 25 representative consultants. The hospital information department needs to implement many demands from various stakeholders, which makes the existing electronic health record (EHR) system unable to meet all of the demands of eSources. The emergence of an ESR is intended to divert the burden of the hospital information department from the enormous functional requirements of the outdated EHR system. The entire research process emphasizes multidisciplinary and multibackground expert opinions and considers the complexity of the knowledge backgrounds of personnel involved in the chain of clinical source data collection, processing, quality control, and application in real-world scenarios. To increase the readability of the results, the researchers classified the main results in accordance with the paragraph titles in “Use of Electronic Health Record Data in Clinical Investigations”, a guide released by the US Food and Drug Administration (FDA).

Conclusions:

This study introduces the requirement dependencies of different stakeholders and the challenges and recommendations for designing ESR software when implementing eSource technology in China. Experiences based on ESR projects will provide new insights into the disciplines that advance the eSource research field. Future studies should engage patients directly to understand their experiences, concerns, and preferences regarding the implementation of eSource technology. Moreover, involving additional stakeholders, including community healthcare providers and social workers, will provide valuable insights into the challenges and potential solutions across various healthcare settings.