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Editorial
. 2017 Mar 17;17(1):43.
doi: 10.1186/s12874-017-0324-6.

Implementation of clinical research trials using web-based and mobile devices: challenges and solutions

Roy Eagleson  1 , Luis Altamirano-Diaz  2   3   4 , Alex McInnis  2 , Eva Welisch  2   3   4 , Stefanie De Jesus  5 , Harry Prapavessis  5 , Meghan Rombeek  2 , Jamie A Seabrook  3   6 , Teresa Park  2 , Kambiz Norozi  7   8   9   10   11   12
Affiliations
Editorial

Implementation of clinical research trials using web-based and mobile devices: challenges and solutions

Roy Eagleson et al. BMC Med Res Methodol. .

Abstract

Background: With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature.

Results: The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy.

Conclusion: We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.

Keywords: Obesity; Paediatric cardiology; Privacy; Security; Web-based technology; e-health.

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Figures

Fig. 1
Fig. 1
Separation of Model, View, and Controller (MVC) for web-based systems. MVC is a pattern for developing applications that contains: Models which represent the data of the application, Views which are visualize representations of the data, such as dynamically generated HTML responses, and Controllers that connect the two by functioning to handle incoming browser requests, retrieve model data and return responses to the browser
Fig. 2
Fig. 2
Breakdown of functions and message passing in classical MVC. This figure describes some of the basic functions of each of the three components of the classical MVC pattern. Separating these roles into three separate components makes the system easier to develop, test, maintain and update. All of which enhances the security of the application and system
See this image and copyright information in PMC

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