RECENT ADVANCEMENTS IN CLINICAL TRIALS AND IMPLEMENTATION

Abstract

Clinical trials are an elementary tool used to estimate the safety and efcacy of new medicinal products, medical devices and other health system interventions. The traditional clinical trial system acts as a quality channel for the development and implementation of new medicines, devices and health system interventions. The concept of a “digital clinical trial” leverages digital technology to improve participant access, engagement, trial-related measurements, and/or interventions. The digital trial has the potential to transform clinical trials by reducing the cost of trials. Bringing together experts in clinical trials, digital technology, and digital analytics to demonstrate strategies to apply the use of digital technologies in clinical trials while considering implicit challenges. This paper describes the current state of the art for digital clinical trials including dening digital clinical trials, describing recruitment and retention using digital technology, outlining data collection elements including wearable technologies, mobile health, digital transmission of data, and consideration of regulatory oversight and guidance for data privacy, security, and remotely provided informed consent, elucidating digital analytics and data science approaches leveraging articial intelligence and machine learning algorithms, Recruiting and retaining participants in randomized controlled trials (RCTs) is challenging. Digital tools like social media, data mining, email or text messaging, electronic health records, electronic medical records, and registry data could improve recruitment or retention.