Perry Brian, Geoghegan Cindy, Lin Li, McGuire F Hunter, Nido Virginia, Grabert Brigid, Morin Steve L, Hallinan Zachary P, Corneli Amy
Clinical Trials Transformation Initiative, Durham, NC, USA.
Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
Contemp Clin Trials Commun. 2019 Jun 20;15:100399. doi: 10.1016/j.conctc.2019.100399. eCollection 2019 Sep.
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.
在临床试验中使用移动技术收集参与者数据具有诸多科学和后勤方面的优势。然而，对于如何将移动技术纳入试验设计和实施，潜在研究参与者的偏好却知之甚少。我们通过一项基于网络的调查，描述了假设的移动临床试验和传统临床试验场景，探讨了患者对参与移动和传统临床试验的看法与意愿、他们与移动技术使用相关的首选试验程序，以及移动技术的首选属性。大多数调查受访者表示，比起依赖标准门诊评估的传统试验，他们更愿意参与使用移动技术的临床试验。他们表示，移动临床试验提供了更大的便利、减少了门诊就诊次数，并且数据收集准确性更高。受访者还报告了在移动临床试验期间对门诊就诊频率、设备培训与故障排除、数据隐私和保密性、数据存储位置以及用户对试验设备收集的数据的访问权限的偏好。随着研究参与者更多地参与收集自身数据以确定试验终点，在移动临床试验的设计和实施中应考虑他们对移动技术的用户偏好，如此处所述。
