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The pharmaceutical research industry has seen a recent explosion of publications and conferences focused on decentralized and digital clinical trials. If you search the terms “decentralized versus digital clinical trials,” however, the results will overwhelmingly relate to decentralized clinical studies, as if “digital trial” were not a discreet category. Decentralized and digital clinical trials are are two different things. Digital trials can be decentralized. And decentralized trials can use digital tools. But the terms describe different concepts. Let’s look at the differences.
A decentralized trial is, by definition, one that is done away from a central research facility. Patients complete their clinical trial visit at a remote location, either through virtual tools, such as video calls and patient reported electronic assessments, or by face-to-face interactions. The relevant feature is the location of the patient interaction.
While digital tools are often used in decentralized trials, digital technology is not their defining feature. Decentralized trials can use paper forms exchanged by mail or through house calls, for instance.
A digital clinical trial uses no paper during the conduct of the study. There may be paper forms associated with the patient prior to study initiation, but they would be digitized and curated as part of the study, with the source document remaining as a paper record. Any study can be digital regardless of the location where the clinical visits are performed. The defining feature is the data capture method of the study.
To conduct a digital trial, several components are required:
A digital protocol
A digital study begins with translating the written protocol into a set of digital objects and specifications that help feed other digital systems for feasibility studies, modeling, and optimization. They include:
Digital IRB package
In a digital study, electronic study documents for review and approval generated from the digitized protocol can facilitate a digital IRB submission package and IRB approval.
Linked to the Electronic Medical Record (EMR) system at each research clinic, the eScreening application identifies potential study participants at each site based on the criteria from the digital protocol. These patient records are reviewed by the site research staff, and eligible patients are invited to participate. Artificial intelligence tools can aid the curation process.
Qualified participants are referred to an eConsent system that digitally describes the study, presents the risks, benefits, and alternatives, and then captures patient consent using digitally documents approved by the IRB. This system facilitates required updates, reconsent procedures and post-study surveillance assessments.
Additional linked systems
Interoperability is major challenge for digital trials. Every clinical trial uses an array of systems to manage both study conduct and data collection during the trial. Each of these systems produces clinical study data and associated case report forms managed in an integrated system. They include virtual visit systems, electronic clinical outcomes assessments (eCOA), medical imaging results, clinical trial management system (CTMS), electronic data capture (EDC) system, adverse event reports, and safety and monitoring systems.
Digital case report forms (eCRFs)
The data captured from the study electronically populates a set of digital case report forms aligned to study protocol and the target EDC system, where they can be reviewed and approval. Once complete, the digital case report forms create a seamless audit trail for data monitoring and verification.
Advantages of digital trials
Better identification of potential patients, efficient study site workflows, and simplified study monitoring enhanced by artificial intelligence are among the benefits of digital trials that will ultimately increase access to research studies. Building a digital trial requires an initial investment. Once the foundational systems and workflows are in place, however, the return will continue for many years.
Kenneth G. Faulkner, PhD, is Senior Vice President of Clinical Trial Solutions at ConcertAI