Digitizing clinical trials

Abstract

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.

Clinical research during the COVID-19 pandemic: The role of virtual visits and digital approaches

“…Indeed, remote patient assessment and electronic capture of biomarker data using devices, smartphones, and sensors will likely be a cornerstone of a decentralized model of clinical research. These biomarker technologies could provide researchers with real-time data between research visits, resulting in earlier detection of adverse and safety events (1). Before their potential can be realized, however, a number of issues will have to be addressed.…”

Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic

“…Remote digital data collection and telemedicine may increase trial screening, the speed of remotely reporting AEs or follow-up data, and potentially allow for advanced analytics with machine learning to detect proximal outcomes. ( 4 , 5 ) Moreover, because poor accrual accounts for 43% of early-terminated phase II-III trials(6), virtual clinical consultations for patients eligible for trials provide an opportunity to increase enrollment and patient satisfaction due to convenience(7). Thus it may further mitigate enrollment challenges and help reach wider populations during the COVID-19 pandemic.…”

“…With only 8% of all cancer patients enrolling on clinical trials,( 5 ) more virtual trials could improve enrollment while also potentially shifting geographic demographics as seen at our center. As we moved towards regional marketing during the pandemic, we saw increases in percentages of in-state participants.…”

How the clinical research community responded to the COVID-19 pandemic: An analysis of the COVID-19 clinical studies in ClinicalTrials.gov

“…To transform clinical trials and lower their cost, a notion of “digital clinical trial” was created to leverage digital technology to improve important aspects such as patient access, engagement, and trial measurement [34]. The US National Institutes of Health and the National Science Foundation held a workshop in April 2019 about the implementation of digital technologies in clinical trials, in which “defining and outlining the composition and elements of digital trials” and “elucidating digital analytics and data science approaches” were identified as two of the five top priorities.…”