RESUMEN
Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a "digital clinical trial" involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.
RESUMEN
Mobile health (m-Health) resources are emerging as a significant tool to overcome mental health support access barriers due to their ability to rapidly reach and provide support to individuals in need of mental health support. m-Health provides an approach to adapt and initiate mental health support at precise moments, when they are most likely to be effective for the individual. However, poor adoption of mental health apps in the real world suggests that new approaches to optimising the quality of m-Health interventions are critically needed in order to realise the potential translational benefits for mental health support. The micro-randomised trial is an experimental approach for optimising and adapting m-Health resources. This trial design provides data to construct and optimise m-Health interventions. The data can be used to inform when and what type of m-Health interventions should be initiated, and thus serve to integrate interventions into daily routines with precision. Here, we illustrate this approach in a case study, review implementation issues that need to be considered while conducting an MRT, and provide a checklist for mental health m-Health intervention developers.