Are Sites on Board with the Shift to Decentralized Clinical Trials (DCTs)?
A conversation with seasoned site leader Nathan Morton.
As the Senior Director and Co-Owner of Coastal Carolina Research Center, Nathan Morton provides strategic planning and operational oversight for a dedicated research center and clinical staff of 50. The center has managed over 750 Phase I-IV clinical trials in multiple therapeutic areas, including Vaccines, CNS, Pain, Orthopaedics, Psychiatric, Cardiovascular, Metabolic, Urology, Women’s Health, Men’s Health, Dermatology, and Gastroenterology. His conversation with Medable is summarized below.
When COVID-19 hit and accelerated the adoption of Decentralized Clinical Trial (DCT) technology, what were the biggest challenges to your site's operations?
Although DCT technology has been moving through the industry for years—I did a webinar way back in January of 2015 on this exact subject—with COVID it became critical to put these remote technologies into practice.
As far as challenges: as a research site we have 70 active trials currently, if each of these trials implements different DCT strategies and standards, it becomes very difficult from a training standpoint. We could take on that training initially at the onset of COVID because most of the trials had shut down enrollment and our workload plummeted, but once things normalized and our workflow escalated it became problematic to manage.
Utilizing DCTs more effectively is something that we need companies like Medable to think through. We have to understand how any new technology will impact the sites within our current models and learn how to integrate these solutions into our normal flow.
Are site's still feeling staffing impact due to the pandemic?
This is the worst labor market I've been a part of, and I've been hiring people for over 20 years. It's extremely difficult to find talent and to retain talent, as we often get poached by CROs we work with, with other local Charleston research facilities, and with area healthcare facilities for clinicians, including physicians, nurse practitioners and nurses.
I’ve had staff members whose spouse or significant others lost jobs during COVID. When you have an employee who is now the sole breadwinner, that puts a lot of pressure on them, and adds to their interest in perhaps seeking out the highest possible paying job they can find. In addition, when daycares or school systems are closed, or their child has been exposed to another child with COVID, requiring the parent (our employee) having to be at home with their child for two weeks in quarantine, it creates enormous staffing pressure.
Our research sites adhere to the needs of our staff, oftentimes with no notice, and that understandably has been extremely challenging. The work goes on whether appropriate staffing is available or not.
One thing we’re potentially excited about is that DCT technology could help alleviate some of this. If we’re able to collect data, recruit and complete charting and some visit requirements remotely, our staff could live anywhere and work from home, thus allowing us to expand out talent pool from which to hire
Do you believe site staff are worried about losing jobs or being scaled out of positions with the tech, such as DCTs? Is that a major concern for sites across the industry?
Well, it hasn't hurt us over the past 18 months. Due to workload, we've more than doubled in size at this point. There are certain types of skill sets, however, which could be affected more than others. For some institutions, I think this technology could threaten some positions, but it doesn’t currently threaten us, although we are constantly having to assess our organizational model given these new realities. We need all the help we can get right now.
Where DCTs could impact sites like mine is in how the protocols are being built. Are we going to have less frequent visits? If so, I may not need as much square footage or the same staffing levels. But I think that’s yet to be understood.
It could also just change the type of staff that you have. It could be that the study coordinators that we have now just need to expand into a different role, or we would need to seek out staff who may have less clinical skills but more technical skills. Most staff would enjoy working in a more flexible work setting which could include both traditional and remote settings.
What can sponsors do to better support sites through the digital transformation needed to transform clinical research with technology?
Standardized guidelines across the industry would be ideal, though there’s too many barriers for that to be a realistic option.
But one of my specific concerns with DCTs is whether it’s going to change the type of volunteer that we can enroll. If we are training these volunteers, and they're bearing a higher burden on the collection of data themselves, and we're not a part of that in any context, then does it change how we recruit? Does it change the type of volunteer we're looking for? Will it require a more highly skilled volunteer? It is critical that data integrity be maintained and I don’t have any evidence, either positive or negative, that DCTs will improve or be detrimental to our study data.
Giving sites some flexibility with how we can collect and maintain that data is required. I’m not fond of a “one size fits all approach” which is generally how most clinical trials are logistically set-up. And then there’s the safety aspect of it. If we’re in a DCT environment, but our physicians believe they need to bring a patient onsite, it’s important we’re not penalized for that, from a contractual standpoint. Some of my concern pertaining to DCTs, is that Sponsors may see these new technologies as a cost cutting measure which may be detrimental to both data integrity and subject safety.
Medable has created a Site Network Counsel (SNC) to partner with sites more closely and get their early inputs regarding product and technology development. What do you think will be the ideal output from this type of coalition partnership?
Well, I like the fact that Medable has patients who participated in trials themselves as part of these coalitions and councils, because we need input from the volunteers. In my opinion, they are the most important stakeholder in this entire enterprise within the umbrella of clinical research. We also need more participation from principal investigators, or clinicians who actually engage with participants every day, who could be better represented in these counsels.
Ultimately the idea is to have shared goals across every stakeholder in the enterprise. We need to appreciate all the various interests that are collectively part of it, and recognize it goes beyond more than just our own personal interests. Medable's been great on all these points, especially in their willingness to reach out to stakeholders like myself and is approaching these potentially very disruptive technologies in a respectful manner that is greatly appreciated.
Technology and innovation within the clinical trial process are rapidly changing the landscape for investigators and their day-to-day operations. What do you think the next significant innovation will be?
The most impactful innovation for us would be to have investigational products directly shipped to the subject. If we could get to the point where, instead of the volunteer coming to us for research, we're taking the research to the volunteer, that would be a positive disruptive innovation. Understanding how to maintain IP integrity with such an innovation would be required in order to provide assurance to both Sponsors, investigators and volunteers.
What does it take to adapt and survive in this world of clinical trials?
Well, you need to have thick skin, for starters, be able to problem solve at a moment's notice, and you need to over-communicate with your internal peers, with sponsors, and with the CROs collaborating with you on projects.
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