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

Abstract

BackgroundWith 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.ResultsThe 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.ConclusionWe 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-017-0324-6) contains supplementary material, which is available to authorized users.

An internet-based approach for lifestyle changes in patients with NAFLD: Two-year effects on weight loss and surrogate markers

“…In general, internet-based programs were shown to be less effective than face-to-face programs; their effectiveness may be increased by telephone recall systems 33 or text messages 34 but the reduced effectiveness is largely repaid by reduced costs and a larger audience. 35 This was also demonstrated in our setting, where nearly 60% of cases engaged in WBI lived outside the metropolitan area (and a few were scattered all over Italy), compared with the 27% of cases who entered the group-based behavioral approach.…”

Development and Presentation of an Ethical Framework for Health and Medical Apps

“…A total of 32 references has been included in this review. (Figure 1) Of these, 18 references were journal articles, [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] seven reviews, [27][28][29][30][31][32][33] three systematic reviews, [34][35][36] two survey results from Australia 37 and the USA, 38 one study report from Germany 6 and one qualitative study from Australia. 39 For further discourse, the principles of biomedical ethics defined by Beauchamp and Childress function as ethical endpoints.…”

“…9,16,31,38 This consequently requires a transparent communication regarding the use of generated information. 14,25,32 From today's perspective, there is still need for action, considering the chances and risks of health and medical apps regarding the individual's autonomy.…”

“…10,12,13,16,20,31,32 The confidential handling of sensitive information can be ensured, for example by encryption via password or access authorisation by authorised persons. 10,14,23 Privacy includes data privacy, personal privacy and security. 22 Security refers to both the protection of personal information and technological security.…”

Virtual Clinical Trials: Perspectives in Dermatology

“…Concerns over transferring large amounts of sensitive health data over the internet can be a challenge, but proper implementation of technologies and defense strategies like storing anonymized data on external web servers secured by ID and password, using secure web mails, and web servers hosted by trusted providers will minimize this risk to an acceptable level [7,35]. The privacy of the recruited participants must be guaranteed.…”