Clinical Trial Site Perspective: Workforce and Infrastructure Shortages, and A Message to Trial Sponsors
Sites are urgently dealing with reduced personnel and facility capacities to serve their existing patient population, on top of taking on industry trials. MarieElena Cordisco, NP-C, APRN, AVP, Clinical Trials, Research and Innovation at Nuvance Health, shares how her organization is navigating those challenges amid increasing demands from sponsors.
What are some of your biggest challenges when running industry trials at Nuvance?
At Nuvance Health, we deliver care to more than 1.5 million patients throughout seven hospitals spanning two states. Our most important goal is to meet the healthcare needs of the communities we serve. Patient visits are priorities for every department. Interdepartmental collaboration can be a challenge, as research studies often compete for services in the organization. We don't have departments that have dedicated time to research endeavors. If I schedule a slot for a test or scan, then I'm taking a slot that a patient would normally have.
Added to this are the gaps in staffing across our organization and in health care overall. Being able to find the time in collaborating department schedules for training is often a challenge as we are competing with their usual duties. The protocol comes to us with a pathway to follow, and a timeline to get consent and other milestones. We have been looking closely at study protocols and internal ways of working to streamline training, scheduling and completion of study assessments.
"We all have slightly different needs, but when you take a look at the overall picture of what sites are asking for, it’s the same. We're talking about being understood by the sponsor to make the protocols more accessible to the patients."
What are the challenges or burdens within protocols?
When considering burdens, we need to think of the patient first, things like how the protocol requirements affect the patient experience. We always have issues when intensive PK/PDs are required. The different time points required for lab testing before and after dosing can present a difficult hurdle to overcome. Some of the time points can be hours after dosing. In an organization like ours, it's almost impossible to have a participant wait for many hours.
You wouldn't want someone waiting in a waiting room for eight hours; nor can you take up an exam room for eight hours. As a site, we review every protocol and detail all the requirements. We've turned down studies that have had too many visits, too many lab draws or patient-facing technology that our population is not able to use.
How do you handle situations like that?
One of the first questions I'll ask, “Is this sub-study required to be part of the trial?” We're very honest with those sponsors as to whether we can handle all the requirements. A sponsor may just eliminate us because of that. There are times where we just turn down a study and the sponsor never comes back to us, so, or they won't come back to us for that particular study.
However, there are times where we are not the only ones that have the same challenge. In that case, the sponsor will come back to us and say, “Other sites have found the same issue; we've changed the protocol.” That's when you know that they're listening. It sounds like a great idea on paper, but the reality is when you have an 85-year-old person coming in for multiple visits or being required to wear a large monitoring device, it’s not feasible.
What are the challenges or burdens within protocols for patients?
The burden on the patient can be high. We've had trials where the device that the patient would use is too cumbersome. We’ve had physicians that turn down trials because there are too many visits for a patient. Some of the ways of getting the data are not necessarily consistent with what the patients are able to do. For example, there was a trial where patients were required to wear a very large device on their wrist. They had to sleep with it. They had to take a shower with it.
What would be your ideal response from a sponsor when you say that you may not be able to fulfill all aspects of a protocol, such as PK/PDs?
I would like to see more options in protocol development. We may not be able to fulfill the PK/PD requirements, but there may be other sites that can. Maybe those could become optional substudies. Could a sponsor get the data from the other sites and continue to have us enroll in the other components?
I talk often about the need to get sites involved early in protocol design. We can tell you what our patients are willing or not willing to do, or what we think can or cannot happen in a study visit. I don't think that really happens quite enough.
"I talk often about the need to get sites involved early in protocol design. We can tell you what our patients are willing or not willing to do, or what we think can or cannot happen in a study visit. I don't think that really happens quite enough."
Is there any specific example of something that comes up often in protocols that sponsors need the site perspective on?
Any patient-facing technology would really be better answered by the site, as opposed to just the sponsor. We know our patients and we know our population. Our physician-patient relationships give us a lot more information about whether we think our patients can manage the technology.
We've had lots of technology that's come in that has been either not user-friendly from the patient-facing component, or there's a language barrier, or it's burdensome to use or wear.
Can you characterize the burdens your organization is facing in personnel, capacity, etc?
One burden we have is available human resources/human personnel. We have definitely suffered from the Great Resignation and we found that some trials were non-performing because we didn't have staff, so we had to opt to leave those trials.
It's not just in the research department, it's across the network. Our nursing staff and physician staff are short. Personnel problems extend to our IT department and our nuclear medicine for example, really all departments. Every department is working short and cannot find the people to come into the organization to fill those slots. That puts a huge burden on how many people we can enroll and who's available to do the work. If you have no physicians, you have no PIs and the physicians that are here are still trying to meet the needs of the patients that are already on their schedule.
What are your thoughts about decentralizing components of a trial?
There's a great opportunity to embed or decentralize components of trials. CTTI (Clinical Trials Transformation Initiative) and The Society for Clinical Research Sites have published recommendations for sites to use when considering best practice for actualizing DCT’s However, I'm not seeing a lot of sponsors coming to me saying, “We have a decentralized trial,” or “We have a trial with decentralized components.” We do have trials that have some aspect of decentralization, but it's not much more than you would have in standard of care. For instance, it might be someone who has a pacemaker that automatically uploads at night.
There are other elements that can be decentralized. For some of the lab work that patients will have to come in for, there's no reason why they couldn't just stop in an outpatient facility and have the labs drawn there. I'd like to see more investigational medications being sent to the patient by courier. We have one trial where patients come in for the drug dispensing every three months, but that's the only thing that happens. Using a courier for something like that seems like a missed opportunity.
What are your concerns about decentralizing aspects of clinical research for your organization?
One decentralized trial component that presented a challenge to us was sending nursing staff out to the patient’s home in a study. That became an issue for us for a number of reasons. First, we don't have a nursing staff in the organization to do that. Our home care department doesn't participate in clinical trials to that level, so we would need to use a third party. Second, a third party coming in is now part of the risk and legal responsibility of Nuvance Health. That is a challenge and takes input from our Legal, Risk and Compliance departments.
We have to consider how to ensure PI oversight. In a situation like that, I ask the sponsor if it is absolutely necessary because we would rather have the patients come into the offices than have to work through barriers that arise by having a third party represent Nuvance Health but who wasn't part of the organization or managed by Nuvance Health.
"Sponsors need more contact with the sites before the protocols get finalized. Whether that is consulting groups as you're developing a protocol, talking to sites you've worked with before, or hiring people with experience with different types of sites, all of that would be beneficial."
What does innovation mean to you, and how do you implement it in your work?
It is any new idea repurposed to improve processes. For example, I’ve created a program using our simulation lab. During the onboarding process for new staff, they are scheduled for a simulated consenting experience in the simulation lab. The goal is for them to consent patient actors using the studies that they currently are assigned to. They get pretested, they get post-tested, and they get live feedback from the patient. In order for research coordinators to really make an impact when they're talking to patients about consent, they need to know how to do that. There is no real formal training for consenting. I can't say that we've gotten more enrollments, but I can say that the research coordinators have improved their presentation to participants.
Do you have any final message for sponsors reading this article?
I will go back to early input into trial design. We all have slightly different needs, but when you take a look at the overall picture of what sites are asking for, it’s the same. We're talking about being understood by the sponsor to make the protocols more accessible to the patients. We're talking about streamlining legal and budgeting processes. We're also talking about screening patients and getting them into the studies and we're also talking about what the patients can and cannot do.
Sponsors need more contact with the sites before the protocols get finalized. Whether that is consulting groups as you're developing a protocol, talking to sites you've worked with before, or hiring people with experience with different types of sites, all of that would be beneficial.
