New methods to collect clinical trial data, especially in view of COVID-19 pandemic, to be considered
Faster and potentially more accurate data collection
Benefits and limitations of mobile app technology in clinical trials
The potential for mobile technology in improving clinical trials is being increasingly recognized by sponsors and researchers. For several years, the Food & Drug Administration (FDA) has been encouraging the use of mobile technologies to enable faster, more cost-effective clinical trials (1). With the concerns of the safety of in-person clinical visits during the COVID-19 pandemic, mobile platforms for remote data collection as well as remote data audits might be a solution for clinical trials now and in the future.
Top of mind in the current climate is the safety of study subjects and staff. On March 18, the FDA released its guidance (2) on the safety of conducting clinical trials during this pandemic. If it is not possible for the study subjects, staff, or monitors to be safely present at the research facility, alternative methods for study visits, such as virtual study visits, may be a solution.
Virtual visits (both for the study subjects as well as the monitors) will include electronic tools to capture data. Overall, the FDA is granting clinical research sites flexibility to consider remote visits and electronic data capture to ensure the safety of all involved.
Data collection in real-time reduces errors and improves efficiency, because the information is transferred directly from the subject in real-time to an electronic data capturing (EDC) system. These include responses collected using wearables such as Apple Watch, Android Watch, FitBit, and other activity or diet trackers, or patient-reported outcomes from customized surveys.
The EDC can also be programmed to detect errors and prompt the participant to correct the error before moving forward. Researchers can also monitor the results in real-time, thus allowing for timely corrective actions.
Real Life in Real-Time
App-based clinical studies can take advantage of the latest in mobile technology to collect real-world data in real-time, such as on physical activity, heart rate, sleeping patterns, food intake, and social interactions without the confounding factors introduced by an artificial clinical trial setting. Mobile apps may also be configured to send out customized notifications for any event or response entered in a study – an especially helpful feature for rapid visibility on adverse events. This indirectly makes a study safer for participants and allows for better outcomes.
Mobile technology not only revolutionizes the way data is collected and monitored, but also allows for more expansive studies with less subject burden. Omnipresent mobile apps enable larger, multi-site studies with unlimited geographic boundaries and subject diversity. Indeed, since 2014, the number of active mobile devices has outnumbered the world population (2).
Virtual, app-based recruitment, test visits, and follow-up appointments reduce the need for physical site visits and saving time for both researchers and participants. More than 75% of US adults surveyed expressed a preference for joining a mobile trial compared to only 7% for a traditional trial (3), suggesting the potential for faster recruitment and better retention in trials utilizing mobile technologies.
Mobile technology has the potential to make clinical trial participation more safe and convenient for participants as well as help researchers improve operational performance and potentially reduce the risk of clinical trial deficiencies. However, the implementation of mobile apps in clinical research requires an understanding of its potential limitations and challenges. These include concerns on data security and resistance from participants such as those with limited experience with technology (e.g., the elderly).
Despite the benefits of mobile apps, some trials are better conducted in a traditional, non-mobile-based setting. Thus, companies interested in using mobile apps in clinical trials are urged to seek out experienced research organizations to ensure the successful implementation of mobile technologies in their trials.
As a leading contract research organization, Biofortis Research, a division of Mérieux NutriSciences, has been successfully utilizing mobile technology in clinical trials. Biofortis offers full clinical trial services from protocol design, recruitment, trial executive, data collection and analysis to writing reports and publications to assist customers who are interested in conducting clinical trials with or without mobile technology.
Valerie Wass, RDN, LDN
Val has worked for Biofortis Research in Addison, IL for 10 months as a Clinical Research Coordinator and she is also a Registered Dietitian. Prior to Biofortis Research, Val worked as a registered dietitian focusing on weight loss nutrition counseling and as a corporate dietitian for a foodservice management company. In her spare time, Val enjoys cooking, walking her black Labrador, and hiking in the mountains.
Claire Dillon, RD, LDN
Claire has been with Mérieux NutriSciences for 2 years in various roles and now is a Clinical Research Coordinator with Biofortis Clinical Research. Claire is a Registered Dietitian with experience in clinical and long-term care settings. In her free time, she enjoys relaxing with her cats and trying out the newest restaurant in town with her friends.
(3) Independent: There are officially more mobile devices than people in the world
(4) Contemporary Clinical Trials Communications: 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.