Scientific Publications by FDA Staff

Contemp Clin Trials Commun 2019 Sep;15:100399

Patient preferences for using mobile technologies in clinical trials.

Perry B, Geoghegan C, Lin L, McGuire FH, Nido V, Grabert B, Morin SL, Hallinan ZP, Corneli A

The use of mobile technologies to collect participant data in clinical trials offers a number of scientific and logistical advantages. However, little is known about potential research participant preferences about how to incorporate mobile technologies into the design and conduct of a trial. Using a web-based survey which described hypothetical mobile clinical trial and traditional clinical trial scenarios, we explored patients' perceptions of and willingness to participate in mobile and traditional clinical trials, their preferred trial procedures related to the use of mobile technologies, and the preferred attributes of mobile technologies. The majority of survey respondents reported that they would prefer participating in a clinical trial that used mobile technology than a traditional trial that relied on standard in-clinic assessments. They expressed that mobile clinical trials offered greater convenience, a reduction of in-person clinic visits, and greater data collection accuracy. Respondents also reported preferences for the frequency of in-clinic visits during mobile clinical trials, device training and troubleshooting, data privacy and confidentiality, the location of data storage, and user access to data collected by the trial device. As research participants become more involved in capturing their own data to inform trial endpoints, their user-preferences of mobile technology, such as those described here, should be considered in the design and conduct of mobile clinical trials.