How Dana-Farber Makes Clinical Trials Fit-For-Purpose in the Community Clinic Setting

What is the clinical research structure Dana-Farber has created with its network of community sites? 

We have two different buckets of sites. One bucket consists of owned-and-operated Dana-Farber community clinics. The other bucket includes locations which we are affiliated with and have clinical research agreements in place and where we're able to offer a set menu of trials.

For both types of sites, we are looking for later phase trials (Phase II and Phase III) that are good fits for our communities. These populations can be different from those who are typically served by the main location. 

We only offer investigator-initiated trials to our affiliated sites because they have their own relationships with industry sponsors and the NCI, etc. For our owned-and-operated sites, we offer IITs as well as industry trials. These trials can be independent of our main campus if there are trials that are a better fit for our community locations. 

How are you working to bring clinical trials to each of your sites as appropriate?

I oversee the operations for our clinical trial network, and one of my main roles for trial selection is to serve as facilitator between our main investigators and our owned-and-operated sites. I network very frequently with the physicians at our main campus. I participate, with people from my team, in disease group meetings, so that we hear about trials and can engage with the different investigators. This allows us to say, “This would be a great trial for X site because they have that population.” 

I’m also responsible for ensuring that operations of our sites, research-wise, are functioning appropriately. That includes hiring, making sure labs have the equipment they need, ordering supplies, etc. We have teams at each site, including coordinators and nurses, who are engaging with physicians, implementing trials, identifying eligible patients and enrolling patients in trials. 

What are the preferences of patients in the community setting when it comes to clinical trials? 

Patients in the community do not want to come in to the main campus for multiple visits nor do they want to travel into the city. They prefer to come in for longer visits to accomplish multiple things including lab draws, get treatment, complete questionnaires, etc., and then come back three weeks later, rather than have to return to a site multiple times. 

And because we don’t want to have to send patients into Boston, we can focus on every single trial and what it requires patients to do. We prioritize simplicity and convenience to keep our patients close to home. However, there are some trials that are better suited for our patients who go to the main campus, and so that can be a determining factor. 

"It is important to have control of the drug on-site in the event that someone is in our clinic today who consents for the trial and is able to start tomorrow. This way, we don’t have to figure out how to transfer the drug from the main campus to a site thirty miles away with enough time to treat the patient."

What is the difference in operations when a trial comes out of the main campus versus not? 

When trials originate from our main campus, that team manages the IRB submission and the major regulatory components. The participating sites do their own patient-specific submissions – safety events, deviations, etc. But when we are opening trials outside of the main location, we have fewer resources available. 

We have two regulatory coordinators for our owned sites who are responsible for the project output, the application, any protocol amendments, etc. It becomes more of a regulatory burden, in addition to what they’re normally managing. Therefore, we have to be careful about the timing of opening our own trials outside the main location, making sure that our staff is able to manage the increased workload. 

When the network of sites is working with industry on trials, what are the common hurdles that come up? 

The same issues come in whether or not the main campus is involved. 1572 forms seem to be a big stumbling block. Our policies require each participating location to have a 1572 because we identify a PI at each location, and we require drug and kits to be sent to each location. That can be a hurdle for industry because of the increased funding with seven sites, instead of one, to send supplies to. 

Budgets and contracts are generally not an issue because we’re one organization, with one budget and contract. Our contracts list out the separate sites participating, but we don’t execute a new contract every time a site is added. However, for any trial that includes an affiliated site, they must execute their own contract because we cannot third-party contract with them. 

"Reducing the number of systems would be the best thing a sponsor could do to make clinical trial participation more attractive to physicians."

Why is it important to have drug shipped to each site, despite the increased administration burden and cost? 

It is important to have control of the drug on-site in the event that someone is in our clinic today who consents for the trial and is able to start tomorrow. This way, we don’t have to figure out how to transfer the drug from the main campus to a site thirty miles away with enough time to treat the patient. 

When we get into randomized or blinded trials, it is just not feasible to have drug at the main campus, randomize someone on a blinded arm, figure out which bottle to transport, and get it to the new location, all while maintaining the proper identifications. That challenge, combined with the timing, means that it’s much more efficient and productive for us to require drug at each location. 

How have sponsors responded to that requirement? 

It takes some explanation in the beginning, but it’s getting easier. We often work with the same companies over and over again so that it makes it easier. Initially, it required a lot of conversation with them and there was pushback. There were trials that we weren’t able to do because we couldn’t come to a place where everyone was satisfied. However, it’s improved over time and change is happening. We’re able to find more ways to make it work for everyone. 

How are physicians made aware of potential trials to participate in? 

The doctors in our community locations hear about trials in multiple ways. The doctors join department or disease group meetings at our main campus and hear about trials there. When I or my nurse manager learn of trials, we will review them and gauge interest from each of our locations by working with the disease lead physician. 

If a physician in one of our community locations wants to participate in a trial, we will either work with the main campus to open it or, if we’re doing it independently of the main campus, we will go through the IRB process, get the sites and staff added, etc. We have site initiation visits, have our nurses educate providers on the trial, and once open, our nurses screen new consults. 

How are physicians alerted to a trial that might be a fit for their patients? 

Nurses are screening manually. We have started to implement AI tools and homegrown technology, but they are not consistently used. If there is a trial that a patient is a good fit for, based on the high-level screening, our nurses talk to the patient’s physician and say, “This patient may be eligible for this trial. Here is a consent form. Let us know and we’ll come in and talk to the patient if there’s interest.” 

"Even though we’ve increased our engagement with physicians and the number of meetings, we’ve seen enrollment increase and a positive shift in the desire to be more involved in research."

How do you avoid overburdening physicians who are participating in a trial?

This is where we utilize our research nurses and study coordinators. They do a lot of work upfront to make it easier for the physician to walk in, talk to the patient about the trial, and then bring in the research nurse., Through this process we’ve increased our physician engagement around the clinical trial process. And, we’re able to get their feedback on what trials they want available at their sites. We’re engaging with them as much as possible to make things as simple and efficient as possible. 

We have heard from our physicians that there are too many systems they have to use when putting a patient on a trial. To address that, our coordinators literally sit with our physicians when they go into a system to review safety reports, or sign off on case report forms, etc., and walk them through how to use the system.

Even though we’ve increased our engagement with physicians and the number of meetings, we’ve seen enrollment increase and a positive shift in the desire to be more involved in research. 

What could sponsors do to make clinical trial participation more attractive for physicians? 

Reducing the number of systems would be the best thing a sponsor could do to make clinical trial participation more attractive to physicians. There’s usually a central lab system, safety report portal, case report form system, etc. If a doctor has patients on five industry trials, there are potentially five different sets of systemsThe number of systems is the top complaint we hear. 

Additionally, industry trials require a lot of PI time. Contract research organizations want on-site visits every month or so to do check-ins or trial re-education. That’s difficult in the community setting, when physicians are seeing up to 30 patients a day and don’t have a lot of administrative time to accomplish all the tasks they need to. If the study staff could take over some of the tasks and lessen the burden, instead of the PI being required to join the meetings, that would benefit patients and be a big time savings and allow all of us to be more efficient. 

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