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Clinical Trials During COVID-19 and Beyond

by Imogen Cheese

The last time I stepped on a plane was back in March… that’s roughly the same time since I drove for more than an hour, had face-to-face in person contact with a client, went a day without checking my phone 10 times for new updates, or had a conversation that didn’t involve the word coronavirus.

It seems that life has changed and may well never return to how it was.

That in itself is a double-edged sword. I have friends and colleagues who express delight at having extra precious time with their young children that working in an office would prohibit. I myself am grateful that a few of my own kids’ evening activities haven’t resumed yet, and as a result my life seems less like a juggling act or never-ending hamster wheel. Balance, it seems, for some.

Health Care and Trials in the Age of COVID-19

Patients, however, seem to be experiencing far greater anxiety levels than ever before.

If you are one of the unlucky few required to attend hospital, you might have (like me) had routine checkups postponed, scans delayed, results take several weeks instead of a few days… that makes for increased anxiety, but it is perhaps not overwhelming.

Some patients have had clinical trials halt, or even postponed indefinitely, and for far too many patients, especially cancer patients, those clinical trials might well have been a lifeline.

Despite all the challenges that COVID-19 has thrown our way over the last 6-8 months, many patients have continued to attend trial appointments, have had routine tests, and visited their hospital centers throughout. And it’s those patients, the ones who either desperately need trials to continue or who have been able to navigate the access routes that have caught my attention. Can providing some or even all of their care at home remove anxiety for patients at a time when anxiety levels are at an all-time high?

CROs Leading Decentralized Trials

Several years ago at an industry conference, the buzz word changed from patient centricity to decentralized trials. Since then, the industry has been slowly adapting, some more quickly than others. The trail blazers, when it comes to decentralized trials, seems to be the CROs.

Global CRO PRA was one of the first to embrace all things decentralized when it came to trials. This included finding ways to take the trial to the patient, to smaller local units for routine tests, or make it easier for the patient to get to hospitals. The shift in mindset wasn’t overnight, but it’s made it a lot easier for their existing trial portfolio to continue without as many interruptions over the COVID-19 pandemic than many had feared.

Covance expanded its offering with the purchase and absorption of GlobalCare into its organization. This acquisition enables them to provide testing, mobile nursing and care for decentralized clinical trials in over 65 countries across the globe. This expands further with the ability to provide chaperoned site services where required and global logistics of supplies required by sites, patients, and support staff alike.

In a similar vein, ICON has made a number of noteworthy strategic growth investments and expansions over the last year. First, in 2018, they formed a strategic collaboration with LabConnect to create at-home kits for specimen collection and tools to facilitate smooth processes remotely. In October 2019, this move continued with the acquisition of Symphony Clinical Research, providing at-home patient care across the UK and into Eastern Europe. The icing on the cake for this decentralized approach was the announcement on 3 September 2020 of the launch of Accellacare, a global research network which they believe will link the more traditional hospital trials and the decentralized at-home provision, and generate higher recruitment levels and faster study startup.

It’s worthwhile to follow the individuals who come up with unique and innovative ways to manage these decentralized clinical trials. People like Rasmus Hogreffe, VP of Decentralized Clinical Trial Innovation at Medable, or Graham Bunn, VP of Medical Sciences and Technology Innovation at Parexel. People who think outside the box, who challenge the status quo, and who above all else look to patients for ideas.

The core of the decentralized trial concept is the patient. The patients who are scared to go into hospitals at the moment and risk contamination of coronavirus (or anything else) with their weakened immune systems. Patients whose lives have already been thrown into turmoil with a diagnosis, and who like so many others in these uncertain times, are finding the balance between health/well-being and financial survival harder than ever before.

Comfort Items and At-Home Visits

Here at Imperial, our trial support printed materials, PPE, and even comfort items for patients at home, in travel, and on site, have increased exponentially during the pandemic. Our clients look to addressing the needs of the patients as the foundation of recruitment and retention. Amongst many recent initiatives for clients, we have been putting together at-home patient care kits that study nurses use to help bring the clinical trial settings and high standards to a patient’s home. So in many ways, the center of a decentralized trial is patient centricity after all!?

Supplies such as pulse oximeters, digital thermometers, syringes, and needles that trials need in order to move forward have been in high demand. Navigating an ever more challenging and disrupted supply chain is a knock on effect of COVID-19 for our team of supply and logistics experts. Moving to a decentralized model brings challenges at a time when many might wish for simplicity, ease, and the familiar.

COVID-19 continues to plague the globe with death, increased cases, fear, uncertainty, and change on an economic level we might never have predicted back in March 2020. It is causing chaos, confusion, and catastrophe.

A Lasting Effect?

But like I mentioned before, there are good outcomes, too… the reconnecting with family when we needed it most. Discovering the simple pleasures of cooking or hiking, finding comfort in what we have, not what we don’t have.

And perhaps more than anything else, coronavirus might well leave a lasting legacy of change for the better, by forcing the hand of those reluctant to move toward decentralized trials. Making it possible, and even encouraging the idea of taking the clinical trial to the patient. If that reduces patient anxiety, if it keeps more patients alive and helps others get access to innovative trials that they might have previously been unable or reluctant to take part in, COVID-19 might well leave a positive gift in its wake after all!

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