Empowering clinical research in a decentralized world

Abstract

The COVID-19 pandemic has been a catalyst for the implementation of decentralized clinical trials (DCTs) enabled by digital health technologies (DHTs) in the field while curtailing in-person interactions and putting significant demands on health care resources. DHTs offer improvements in real-time data acquisition remotely while maintaining privacy and security. Here, we describe the implications of technologies, including edge computing, zero-trust environments, and federated computing in DCTs enabled by DHTs. Taken together, these technologies-in the setting of policy and regulation that enable their use while protecting the users -extend the scope and accelerate the pace of clinical research.

Evaluation of a blockchain‐based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs

“…Decentralized clinical trials are characterized by data collection in an extensive environment with little engagement of study intermediaries 9 . Despite the low‐trust environment where the data were collected, the concept remarkably gained attention after the coronavirus disease 2019 (COVID‐19) pandemic 10 . Considering the robust data integrity blockchain provides, blockchain can be a plausible systematic solution for data integrity in decentralized clinical trials.…”

Lessons Learned Recruiting and Retaining Pregnant and Postpartum Individuals in Digital Trials: Viewpoint

“…With regard to costs, digital trials are also likely to be more efficient because they require smaller teams of investigators [ 2 ] and avoid power reduction due to clustering, which is an issue when recruiting from multiple sites [ 13 ]. Further, digital technologies, which allow for continuous data collection or data collection at more time points, can reduce costs related to clinical assessments [ 14 ].…”

Decentralised clinical trials in multiple sclerosis research

“…15 DCTs can help reduce this efficacy-effectiveness gap by enabling the conduct of pragmatic trials on a larger number of participants with more heterogeneous demographic and clinical characteristics from different locations and practice settings. 14,15 RCTs also examine the efficiency of therapeutic interventions, that is, their costeffectiveness. 18 There are benefits to undertaking such economic analysis as part of RCTs, such as using prospectively collected patient-level data rather than performing retrospective population studies, but there are also limitations, 18,19 which could be overcome through DCTs.…”

“…10 A transition from conventional, centralised RCTs to DCTs was on the horizon prior to the COVID-19 pandemic, 7,8,10 but the demand for such evolution in the design and conduct of RCTs has been recognised more widely during the pandemic and some of their techniques have been rapidly adopted. [12][13][14] RCTs play an important role in multiple sclerosis (MS) research as new disease-modifying therapies (DMTs) and symptomatic treatments are still required. In this paper, we review the existing evidence and gaps in knowledge in designing and conducting DCTs in MS research.…”