Is The Advent Of Decentralized Clinical Trials A Blessing Or A Curse?
By John Illingworth
As the evolution of wearables, mHealth apps, and other technologies has minimized the need for patients to endure arduous in-person monitoring, decentralized clinical trials (DCTs) have been on the upswing. In the past year, necessity born of COVID-19 escalated DCTs’ use exponentially — and now that patients have begun to adapt, there is no going back. While sponsors, concerned about patient-centricity, are embracing the idea, sites are worried about implementation. They are asking: “Can we really do this?”
Sites’ foremost concerns revolve around data: How can they monitor the data? Will data collected remotely be as good as data collected on-site? How can they manage patient follow-up without in-person visits? While each of these questions highlights a legitimate challenge, concrete solutions exist.
ADJUST PROTOCOLS TO RECOGNIZE A SITE’S NEW BURDENS
Effective remote monitoring requires that all documents be available online, to be examined and analyzed off-site. This means sites must upload all documents that are not electronically generated — which can become a full-time job at large sites. In a bid to support sites, many sponsors are rewriting their protocols to take into account these new burdens and to further support sound data monitoring.
AMP UP TRAINING FOR DATA ACQUISITION AND PROCESSING
Despite the apparent simplicity of mHealth devices, like any technology, mHealth presents challenges: setup, validation, troubleshooting. Someone’s not connected to Wi-Fi. An alarm sounds because data weren’t uploaded at the correct time. Human errors occur — and sites will need to be armed and ready.
In addition, the role of the clinical research associate (CRA) has shifted dramatically over the past 20 years, becoming increasingly analytical. These same transitions are occurring with study coordinators and site personnel. To meet these new circumstances, sites must embark on new training and new protocols. Sites can also pull in external resources — such as mobile nursing — to extend their capabilities.
A BRIDGE BETWEEN SITE AND PATIENT
Often, sites resist the idea of mobile nursing, given the need for oversight and accountability. Yet, mobile nursing presents a logical answer to many of the issues related to mHealth devices. When a problem arises, the fastest solution is to send a nurse to the patient’s home to investigate; the nurse can recognize an adverse event, make necessary adjustments, and ensure a verifiable audit trail all in real time — and in a way that is convenient for the patient. That maximizes the chances of keeping the patient in the trial.
Like any other member of the trial team, mobile nurses follow a synchronized set of procedures and protocols, ensuring patient-to-patient consistency — even when a trial is spread across a wide geographic area. And like any potential partner, they can be asked to produce verifiable evidence of past quality — audited data that were shown to be solid proof they understand quality management.
FIND WAYS TO EMBRACE DCTS
Remote technology is here to stay, and its utility and adoption only continue to grow. That means a corresponding expectation on the part of potential clinical trial patients that the convenience associated with wearables and other mHealth devices and technologies will erase much of the burden of participating in a clinical trial.
Sponsors are also enthusiastic; DCTs simplify recruitment and retention, and technology-driven data collection may be more cost-effective and accurate. Now, sites need to find ways to meet the challenges of this change.
Change can be disconcerting, and the prospect of DCTs may make sites question their viability and utility. If a large percentage of a trial can be handled remotely, what is the role of the site? Yet truthfully, the need for sites won’t go away. They have the equipment, the experts, and the experience. They will simply need to accommodate new protocols, processes, and partners that can lead them into a future that seems already here.
JOHN ILLINGWORTH is founder and chairman of Illingworth Research Group, a Syneos Health Company. He is an honorary lecturer in clinical research courses at Liverpool John Moores University.