Leveraging Smartphone Applications for Clinical Trial Data Collection: Challenges in Data Quality and Verification

Smartphones has rapidly evolved as a common form of information and communication technology gadget, easy to use and widely available to a larger number of the population. It is being employed in clinical research in recent times in several dimensions. This thesis aims to explore the extent of usage of smartphone apps in clinical trials and to address the data quality and verification issues. This study is a retrospective analysis of randomized controlled trials published on ClinicalTrials.gov database using smartphone apps as data collection tool between January, 2018 and December, 2022.

A total of 1056 trials was identified of which 920 was analysed based on the inclusion and exclusion criteria. The results show increasing number of trials on yearly basis with oncology trials leading the list by indication (8.26%). Trials of behavioural interventions and devices were most prevalent (45.54% and 24.34% respectively) whiles the United had the highest number of trials(40.65%) using these apps. Remote assessment of trial data and evidence of verification were 53.19% and 36.17% respectively.

The results suggest a fundamental shift from the traditional clinical trial data acquisition especially in trials of behavioural and device interventions. However, drug interventions seem not to utilize these innovative technologies as expected, possibly due to the regulatory complexities surrounding the use of smartphone apps for this purpose. There is still the need to address the validation of data sourced from these apps to enhance the quality and reliability of trials using these methods for data collection.