Background: The successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical investigators; however, little information is known about the perspectives of investigators using mobile technologies in clinical trials.
Objective: The aim of this study was to seek investigators' insights on the advantages and challenges of mobile clinical trials (MCTs); site-level budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and the advantages and disadvantages for trial participants using mobile technologies in clinical trials.
Methods: Using a qualitative descriptive study design, we conducted in-depth interviews with investigators involved in the conduct of MCTs. Data were analyzed using applied thematic analysis.
Results: We interviewed 12 investigators who represented a wide variety of clinical specialties and reported using a wide range of mobile technologies. Investigators most commonly cited 3 advantages of MCTs over traditional clinical trials: more streamlined study operations, remote data capture, and improvement in the quality of studies and data collected. Investigators also reported that MCTs can be designed around the convenience of trial participants, and individuals may be more willing to participate in MCTs because they can take part from their homes. In addition, investigators recognized that MCTs can also involve additional burden for participants and described that operational challenges, technology adoption barriers, uncertainties about data quality, and time burden made MCTs more challenging than traditional clinical trials. Investigators stressed that additional training and dedicated staff effort may be needed to select a particular technology for use in a trial, helping trial participants learn and use the technology, and for staff troubleshooting the technology. Investigators also expressed that 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 the use of mobile technologies in future clinical trials by proactively identifying and addressing potential challenges.
Keywords: clinical research; clinical trial; digital health; digital health technology; mHealth; mobile applications; mobile clinical trials; mobile devices; mobile technology.
©Kevin Christopher McKenna, Cindy Geoghegan, Teresa Swezey, Brian Perry, William A Wood, Virginia Nido, Steve L Morin, Brigid K Grabert, Zachary P Hallinan, Amy L Corneli. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 12.02.2021.