How Can We Get Patients in Community Care Settings Access to Clinical Trials?

Introduction

Integrating trials into community health systems presents distinct challenges, but if done successfully, would open up research for a more diverse and inclusive patient population, address industry challenges in recruitment and retention, and possibly even shorten the lifecycle of cutting-edge therapeutics. 

Through interviews with researchers, healthcare executives, and clinical trial professionals, we examine the current challenges facing community health systems getting patients more access to clinical trials, and how we can move forward. 

Why this matters so much 

Bringing clinical research into the care setting can offer patients, community-based  health systems, and pharmaceutical and biotech companies many positive upsides: bringing patients access to cutting-edge science, hospitals gaining and retaining top-tier physicians, community settings being able to treat patients locally versus sending them to faraway academic medical centers, and trial sponsors recruiting diverse and representative patient populations into their studies. 

Community hospital and health systems can make significant contributions to medical science and patient care, but face several barriers to clinical research, which can be addressed through: 

1. Strengthening infrastructure and financial models

2. Enhancing physician and provider engagement in clinical research 

3. Addressing resource constraints, community site concerns, and the required operational changes 

4. Improving patient awareness and recruitment

5. Creating collaborations that benefit industry, academia and communities

The challenges to address 

Executive Buy-In

Unlike academic centers where research is a core mission, community health systems generally focus on patient care rather than research. Bringing access to trials into those settings begins with executive buy-in and a strong business case for research. 

Donna O’Brien, National Advisor, Manatt Health, explained: “The executives have to agree that doing clinical research is good for patients and will give them a competitive advantage.” This includes showing data on the number of patients who  go to other hospitals  if they aren’t offered clinical trials because they view it as an indication of state-of-the-art care, and the number of top physicians who won’t be recruited or retained if they can’t practice the kind of medicine that includes clinical research. 

She has encouraged healthcare executives to think about the long-term value that clinical trials might add, and weigh the cost of building the infrastructure against the loss of losing patients and staff to other institutions. 

Infrastructure

To do clinical research at scale, establishing a clinical trials office, ensuring regulatory compliance, and managing data collection are some of the fundamental needs. Dr Eric Feldman, Director, Early Phase Clinical Trial Program, Montefiore Cancer Center said: “It's not just bringing the doctors in and they'll open a trial. You have to have people to collect the data. You have to have a clinical trial office. You have to have regulatory experience.” 

While some institutions have done that in-house, Dr Feldman and Dr Christina Brennan, SVP, Clinical Research from Northwell Health, both cited strengthening connections between AMCs and community hospitals, creating either full or partial ownership models, or networks, that could share costs, resources and revenue. 

Oregon Health and Science University, Duke Regional Hospital, and Northwell Health, are examples of innovative partnerships between independent hospitals and AMCs, hospital-university partnerships, or partially/entirely owned models. 

Patient access

Despite popular belief that clinical trials are concentrated in academic medical centers, David Shulkin, former U.S. Secretary of Veterans Affairs, noted that a significant portion of clinical trials (77%) occurs in community settings. But for patients, accessing clinical trials can be challenging due to limited awareness about available trials at their community providers and uneven participation from physicians in clinical research, even in the same office. 

That can be alleviated with broad awareness campaigns about clinical research, going into nontraditional community settings to educate people, patient-matching tools that can help physicians connect patients to the right trials, and low-burden trials (such as sample collection or observational) to introduce the concept of clinical research. 

Staffing

“You have to invest a fair amount in staff and capabilities to be able to adequately participate in clinical trials. This work tends to have peaks and valleys, instead of a consistent source of revenue,” said Dr Shulkin. “It is challenging to maintain that level of infrastructure unless you have a consistent flow of new clinical trials into your system.”

That level of uncertainty was also experienced by Jeff James, CEO of Wilmington Health. “You really never know what your volume is going to be. Studies that you think are going to start may never. Studies that have started may end sooner. Studies you think you would get, maybe you don’t. It’s hard to plan for and manage that growth in an uncertain environment.” 

Dr Shulkin felt that a system that reduced financial barriers with regular advanced payments for sites, eliminating the peaks and valleys of the current system, would enable community sites to do invest in infrastructure, but acknowledged that the burden could not fall on a single sponsor, but likely a government entity. 

Physician Buy-In

Physicians care about their patients, and don’t want to necessarily refer them to a clinical trial without exhausting all existing options, or if recommending them to a trial means that physicians don’t see their patients anymore.

Dr Feldman said that a disincentive for making the financial and personnel investment into clinical research at a community site is that patients might go to the larger AMCs anyway. 

However, Dr Brennan pointed out that if there were strong collaborations in place, patients wouldn’t necessarily have to choose between an AMC or their community hospital. “If we as AMCs and larger healthcare systems look at them as partners, the continuum of care can happen with them, or they can be satellite sites for follow-up,” said Dr Brennan. 

Burden of time and resources

Finally, there is the challenge of time: patients in clinical trials are a greater time investment than patients who are not in clinical trials, and in an economic environment where hospitals and health systems make their money on how many patients they are able to treat, taking 25 minutes to explain and recruit a patient to a clinical trial, versus five minutes to recommend them to the standard-of-care, matters. 

To combat this, Ms O’Brien cited the need for a better patient-matching tool: “Right now, it’s a provider thinking that a patient could match to a certain trial, based on the inclusion-exclusion criteria.” A patient-matching technology that could combine inclusion/exclusion criteria and EHR data, and be capable of screening a doctor’s upcoming patients and recommending trials, would reduce the manual burden on busy physicians as they would have a smaller number of patients to consider. To date, there are not ideal technology products for this, but they are improving.

Dr Shulkin also said that providers should make it easier for patients to know if clinical trials were available with certain physicians. Advances in data management, cloud-based resources, wearables and data analytics, could reduce the burden on patient participation and site data management. 

Where and how to start?

Northwell Health

Dr Christina Brennan, Northwell Health, emphasized that physician buy-in is crucial for clinical research to be considered a viable care option. Physicians are often the primary source of information about clinical trials for patients, making their support essential. 

However, many physicians view clinical trials as a last resort rather than an integral part of patient care. To address this, Dr Brennan suggested investing in training and support for community physicians to help them better understand and promote clinical trials.

Resource constraints are a significant barrier for community hospitals. Dr Brennan pointed out that the expenses associated with conducting clinical trials – such as funding, staffing, infrastructure, and technology – can be substantial. The rapid advancement of technology adds to these costs, making it difficult for smaller institutions to keep up. 

Dr Brennan felt that forming partnerships between community institutions and larger academic centers with established research capabilities would mitigate and address some of those challenges, and provide those AMCs with better patient access. 

“Patients love things right within their community,” she said. “For larger academic medical centers who are challenged with getting more patients in the community involved in their trials, they can work with the smaller hospitals and clinics to have them as satellite sites for enrollment.” 

Duke University

Denise Snyder, Associate Dean of Clinical Research, Duke University School of Medicine and Dr Emily Ko, Assistant Professor, Duke Department of Medicine and Hospitalist at Duke Regional Hospital, are leveraging the Duke connection between the university and the community-based hospital to bring trials to patients. 

Dr Ko said that one key challenge facing the hospital was the lack of investigational pharmacy resources, which are crucial for therapeutic trials. The organization has addressed this by developing a hybrid pharmacy system where investigational tasks are centralized at the main hospital, while community sites manage medication distribution with trained clinical pharmacists.

Ms Snyder also noted the benefit of community hospitals in patient navigation. Community settings often provide a more accessible and less intimidating environment for participants compared to large academic centers. This can improve patient engagement and retention in trials.

Wilmington Health

Mr James, Wilmington Health System, discussed the frustration with the traditional industry approach to clinical trials: “The legacy approach to research by sponsors and CROs when dealing with large, truly integrated networks lends itself to significant inefficiencies. If we have ten locations, we have to fill out ten feasibilities.” 

He felt that the sponsors and CROs weren’t evolving to keep up with how sophisticated multi-specialty group practices could be, both in terms of technology and attitude. He wanted to see sponsors allow for multi-site community health systems to pick the sites that they felt would maximize patient contact, basing their decision-making off a deep well of personal knowledge about the community they serve. 

Mr James also reinforced how much patients valued keeping things in their community, and how the community health system had knowledge that sponsors don’t, about patient habits. 

“We cover a relatively small, but dense geography. A sponsor might see two of our locations, separated only by a few miles and the Cape Fear River,” he said. “But we know that there are so many patients who don’t want to drive across that bridge, so they would be better served with the site on the other side of the river. Or patients who don’t drive downtown because the traffic is too challenging." 

Real-world examples

Oregon Health & Science University

Oregon Health & Science University (OHSU) developed an affiliation program for several local community hospitals, with OHSU providers treating patients at those locations. They expanded that connection and integrated clinical trials into those community sites by setting up systems in which OHSU providers engaged in clinical research could recruit patients at non-OHSU sites, leveraging the university’s resources and expertise. 

“The benefits of the affiliation for the community hospitals are that they can offer trials to their patients, and they don’t lose the patients to OHSU. They can keep patients in-house, and OHSU takes over the burden of enrollment, managing the drug, etc,” said Madeline Sparks Cresswell, Affiliate Research Program Manager, Oregon Health and Science University. 

OHSU utilizes financial agreements where community hospitals pay for on-site staff and services while OHSU handles the research logistics. This approach helps community hospitals retain patient care revenue while benefiting from the research trials managed by OHSU.

St Lawrence Health System

St Lawrence Health System operates in one of New York State’s most rural and economically disadvantaged areas. Kylie Sands, Clinical Research Operations Manager, outlined how they provide their community with access to clinical trials. 

They spend a lot of time on community engagement, attending local community events like farmers markets and county fairs to educate residents about research opportunities. “Our patient populations are a little hesitant in some ways. We've been lately trying to take on more sample collection studies and observational studies to ease into more research and get their feet wet.”

Sands and her team proactively engage with physicians, reaching out to new providers to gauge their interest in research and provide support for industry-sponsored projects. 

Their resource constraints mean that they generally focus on more advanced studies rather than early-phase trials, as they don't have access to a refrigerated centrifuge and only recently got access to a negative-70 freezer. However, with limited personnel and resources, Sands’ team has become versatile. Coordinators at St Lawrence are involved in all aspects of research operations, from processing samples to conducting tests.

Stamford Hospital

Dr Suzanne Rose, Executive Director, Clinical Research, Stamford Hospital, worked to create a compensation model that accounted for the increased time and effort associated with clinical trials. Stamford offers research-related RVUs (relative value units) that count the same as clinical RVUs, thus making research participation more appealing by not affecting their clinical productivity or compensation. 

Stamford uses a combination of internal and external methods for patient recruitment, including a comprehensive website, internal newsletters, and patient-facing information in exam rooms. That, combined with their physician compensation model and their partnerships with institutions like Dana-Farber and Columbia Presbyterian, have kept them competitive despite being surrounded by larger health systems. 

However, they still feel like the industry passes over them in favor of AMCs. “The perception is, “We have Columbia or Mount Sinai, Nuvance or Northwell – huge systems where we can get more patients,” said Dr Rose. However, Stamford’s power lies in the deep ties that they have with their community. Dr Rose felt that a consortium of community hospitals could be valuable, to advocate with pharma for more clinical trials.

Conclusion

By forming partnerships, leveraging existing resources, with some investment in technology and employing innovative recruitment strategies, community hospitals and health systems can contribute significantly to clinical research, benefitting both patients and the broader scientific community.

If you’re interested in learning more about integrating clinical research as a care option, visit CRAACOevent.com for information about the upcoming CRAACO: Clinical Research as a Care Option conference, September 16, 2024 in Philadelphia, PA.