JMIR Publications

ABSTRACT

Background:

Successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical researchers, yet there is little information about the experiences of investigators using mobile technologies in clinical trials.

Objective:

We sought investigator perspectives about the advantages and challenges of mobile clinical trials (MCTs); budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and investigator perspectives regarding the advantages and disadvantages of trial participants using mobile technologies in clinical trials.

Methods:

Using a qualitative descriptive study design, we conducted in-depth interviews with twelve study investigators involved in the conduct of MCTs.

Results:

The investigators represented a wide variety of clinical specialties, and reported using a wide range of mobile technologies. Investigators most commonly cited three advantages of MCTs over traditional clinical trials: 1) more streamlined study operations; 2) remote data capture; and 3) improvement in quality of studies and data collected. Investigators also reported that MCTs can be built around the convenience of trial participants, and individuals may be more willing to participate in MCTs because they can take part from home; although investigators also recognized that MCTs can involve additional burden for participants. Operational challenges, technology adoption barriers, uncertainties about data quality, and time burden made MCTs more challenging than traditional clinical trials. The selection of a particular technology by investigators and/or clinical research sponsors to use in the trial, participant use of the technology, and staff troubleshooting may require additional training and dedicated effort. Moreover, sharing data collected in real-time with investigators and trial participants is an important aspect of MCTs that warrants consideration, and potentially additional training and education.

Conclusions:

Investigator perspectives can inform use of mobile technologies in future clinical trials by proactively identifying and addressing potential challenges.