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funding gaps and missed data: the case for bringing clinical trials to community hospitals
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funding is a massive hurdle for community hospitals getting involved in clinical trials, but the benefits outweigh the costs.
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clinical research typically occurs in large academic centres, urban city centres, and larger metropolitan areas, leaving the unsung heroes like community hospitals almost entirely out of the equation. however, by doing so, researchers miss out on some unique and potentially advancement-driven opportunities to further progress clinical research in canada.
carley mcpherson, director of research at lakeridge health, oversees the clinical trials research program and the research ethics board at the durham region, ontario health system. she aims to “sustainably grow research capacity” at lakeridge health to improve clinical trial access, diversity, and patient care in canada.
she acknowledges that the larger entities are great for their specialization capabilities, but community hospitals remain a massive untapped market in the clinical trial space.
“the majority of patient contacts as a whole are actually happening at these entities (community hospitals). so, if patient contact is happening there, but we don’t necessarily have as much clinical research going on, there’s a whole missed opportunity in terms of access for these patients and representation of our population,” she said.
she goes on to say that by utilizing the patient connections in community hospitals, clinical trials can improve their data significantly because they will have better connections to the general population and “a larger range of individuals from different socioeconomic, cultural, geographical backgrounds.”
the main issue stopping community hospitals from taking advantage of the opportunity to advance clinical research is funding, which, as many researchers know, can be a significant hurdle even in more established research institutions.
using community hospitals to improve clinical trial data and patient care
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when clinical trials are conducted on groups of people that reflect the general population, the data is better. the health outcomes for those who will eventually take the drug are better, too, because they have been tested in all subsets of people, all cultural groups, and all genders.
it’s not just when the drug reaches the market that it will be better, though. when trials are conducted in community hospitals, people from various backgrounds are there to be asked to participate, allowing them access to cutting-edge medications or technologies that they would otherwise not be able to access, giving them life-changing care faster.
“not only is it a benefit for the patients themselves to have access to these alternative or complementary treatments, but it would also improve the clinical research data that would be obtained from these trials,” said mcpherson.
diversity in clinical trials is a long-standing issue that has yet to be fully addressed, but community hospital participation in clinical trials can foster positive change in that department as well.
“if you’re only receiving participation from select communities, then you can’t very well deploy that new treatment or diagnostic and say it’s going to work for all,” said mcpherson.
since clinical trials require staff recruitment – people able to monitor and treat patients – those already working in the hospital could enrol in a clinical trial, expanding their careers while also learning about the latest therapies that they can use to help patients once new modalities are approved. this essentially keeps these medical professionals on top of the advancements in medicine.
“if we’re engaging in more research in community hospitals, you’re providing opportunities for staff to engage in different avenues. there is evidence that you can improve staff satisfaction because they’re contributing to patient care or improved outcomes in a different way, you know?” said mcpherson. “you really can offer additional recruitment opportunities, and i think it’s just about advancing the knowledge within that hospital as well because if you’re continuously involved in this research, teaching, learning, you’re up to date on the latest information, and so all of that comes together for improved patient care and outcomes.”
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a lack of funding keeps community hospitals from reaching their potential
medical researchers rely heavily on grants from the government, corporations, and other institutes to conduct clinical trials on new medical therapies and interventions.
government organizations, such as the canadian institutes for health research (cihr), have millions of dollars to allocate to clinical trials. however, applying for these grants as a community hospital is unlikely to yield a positive outcome.
when it comes to the ministry of health, there is no direct financial support for clinical trials.
“the ministry of health only provides funds for direct patient care activities. so, your surgical units, your oncology units, it’s only for if a patient is coming in, they need a diagnosis, they need treatment that’s already been approved as standard, that’s where the funds can go,” said mcpherson. “not a single dollar is permitted to go to research because it doesn’t fall within that envelope.”
the ministry of health allocates annual hospital funds only to patient care, but mcpherson and other medical researchers want people to understand that research is patient care.
“so, that’s part of the advocacy is that we actually sit there and go, ‘no, no. research is healthcare,’ because every drug, every therapeutic, every diagnostic test, rehabilitation plan, it’s all either been developed or refined through research.”
she continues, “research is healthcare, so we should be getting direct funding.”
other funding eligibility requirements don’t explicitly state that community hospitals cannot be involved. however, they do have stipulations that make it nearly impossible for them to apply for and receive funding.
“any funding opportunity, you have to look at the eligibility requirements, and within that, there’s usually two things. one at an individual level and one at an organizational level,” said mcpherson. “one of the biggest factors is you need to have an academic appointment, so that would mean you would need to have some level of a professor appointment or adjunct faculty with a university, potentially a college, depending on the opportunity.”
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while filled with trained medical professionals, community hospitals typically don’t fall into that academic category unless they have cross-appointed physicians, meaning they work as the hospital while also being affiliated with universities or colleges in the area.
mcpherson notes that plenty of the physicians in the lakeridge system are cross-appointed, but that’s not the only obstacle to their receiving funding. the organization must also have a level of staffing to support the sheer depth of the application and requirements for maintaining specific policies that need to be in place to administer the funds.
“if you don’t meet those, you can’t even get your foot in the door,” she said. “you’re not even allowed to throw your hat into the ring, and i think that’s a major challenge for a lot of community hospitals is because they just don’t have the personpower to kind of go through all of that when they’re trying to build their structure and their clinical trials unit from the get-go.”
the hospital would also have to establish an agreement with other organizations as a partner to get funding because they don’t get to hold the funding themselves even if they meet the individual criteria of being able to apply for the grant.
“the only way that we can really get funding is if we’re eligible for some grants, which there’s smaller opportunities there,” said mcpherson. “or if we are partnering on a clinical trial, for instance, it would be a pharmaceutical company that would come to us and say, ‘we will pay you x number of dollars to open the trial, to open the study’ because there are different activities (you need to pay for).”
she continues, “that’s where so many places struggle because do you have enough funding coming in to support that? what kind of contracts are you taking in? because if you work with the pharmaceutical company, they’ll often offer more dollars for those research activities, but if you’re working on, we call them an academic study or an investigator-led study … a lot of those studies don’t cover all of the costs.”
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finding solutions to improve community hospital eligibility in clinical trials
to advance the clinical trial space into more community hospitals, the financial roadblocks need to be addressed. there are two ways that can be done, according to mcpherson.
“one is either establishing some additional supports that would help us in those applications,” she said. “and it’s not just the development of policies, but it’s also structuring your finance capabilities, your understanding of those teams.”
mcpherson notes that there is also an educational component because many financiers are unaware of the issues and how funding a community hospital trial would benefit canadians. government involvement is also needed.
“if places like cihr were willing to provide community hospitals specific funding opportunities, that would go such a long way,” she said. “i recognize that it’s not going to be at the same level as if you need the full eligibility requirement, but it could go a long way to just enhancing ontario’s clinical community hospital capacity to get the ball rolling.”
collaboration between different organizations and groups is also imperative to push clinical trials in community hospitals forward. it involves sharing resources, knowledge, and mentorship that can blend together to create a harmonious community, all vying for the same goal: to improve clinical trials and progress healthcare access and viability in canada.
“what i hope to have is that larger centres can recognize the untapped potential that community hospitals have and can recognize that we have the skills, expertise, appropriate regulatory frameworks that can help support their studies,” said mcpherson. “not enough people recognize that untapped potential really is there.”
“we need to see the tangible progress and to see the needle move because we’re sitting and waiting. our patients are sitting and waiting, and we don’t have that time because these are people’s lives or their quality of lives.”
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