The Real Challenges that Stop Hospitals from Integrating Clinical Trials into Clinical Care
Former healthcare executive and current national advisor at Manatt Health, Donna O’Brien gives pharma readers an insight into how hospitals view trials, the hurdles they are currently facing and opportunities for sponsors to get more involved.
Why don’t hospitals, academic medical centers and health systems do more clinical trials?
A clinical trial infrastructure is often viewed as a cost rather than as a strategic investment. In any setting, to accrue more patients, organizations need a supporting and efficient infrastructure as well as a clinical practice culture that embraces research as part of their care delivery model. This does not happen without management support, but it is worth noting that there are so many other pressing issues facing healthcare executives, with clinical care always as the priority in addition to financial and workforce challenges, dealing with a post-pandemic landscape, and competition from inside and outside the industry to name a few.
In academic medical centers, research is integral to their mission, and clinical trials are a priority for physicians. However, in community hospitals, while many do offer clinical trials, the focus is on clinical care with more limited clinical trial programs. Community hospitals do have great untapped potential to offer or expand clinical trials, and with the right support, I think this is where attention should be directed.
Does a hospital ever make back the investment on personnel and technology?
Without a supporting administrative and clinical culture, it is hard to accrue many patients, and that is necessary to achieve the hospital’s clinical and financial goals. For this reason, it is important for the hospital to track accruals to their trials compared with their accrual goals and to understand what the barriers are if they have low accruals.
I also encourage hospitals to look more broadly beyond the short-term financials of what it costs and what a hospital makes back. They should consider the long-term value of retaining a patient who would otherwise go to another center and/or the value of being able to recruit or retain a key physician who is attracted to a strong and efficient clinical trials program. These factors are just a few examples of how a strong clinical trials program can be seen as a strategic investment.
"I also encourage hospitals to look more broadly beyond the short-term financials of what it costs and what a hospital makes back."
What don’t hospitals realize about investing in staff and resources?
Some hospitals don’t realize that there are a lot of new options for partnering. You don’t need to have those services in-house, as there is an emerging “buy vs. build” opportunity. Hospitals are used to outsourcing the revenue cycle, various lab services, supply chain, etc., but not necessarily outsourcing parts of the clinical trial infrastructure. They augment staff, but this is not the same as an outsourcing or partnership model. There are many innovative companies in the industry that support just that and can serve as very attractive partners. These approaches can be cost-effective and create more efficiencies, which also makes it easier for physicians to participate in clinical trials.
You’ve been a healthcare executive and have integrated trials into hospitals. Can you tell us about that work?
The National Cancer Institute asked me to support the development and implementation of an initiative that would create a research platform for clinical trials in community hospitals. I was able to draw upon my experience as an executive at MD Anderson Cancer Center, where clinical trials were part of our care delivery model, and as executive vice president of a regional health system where few trials were offered.
I had a good understanding of a culture where clinical trials were promoted, but I also understood the reality of community hospitals with many private practice physicians and why it was challenging to offer trials. The program was structured as a learning collaborative with NCI and 30 participating hospitals. Solutions were developed by working together, sharing best practices and evaluating them. Many tools and resources were developed to give organizations an implementation road map. The organizations really appreciated having a roadmap to follow.
"You must get executives involved and educate them on how community hospitals could not only have a strong clinical trials program but also how there could be added value for their patients and their organizations."
What was the first step to integrating trials into hospital systems?
You must get executives involved and educate them on how community hospitals could not only have a strong clinical trials program but also how there could be added value for their patients and their organizations. Usually trial sponsors speak to physician principal investigators, but they don’t control organizational resources. It is important to engage management and lay out for them what kind of infrastructure and clinical practice culture is needed to support a clinical trials program and then to provide an approach for establishing a business case for their organization.
For the NCI program, healthcare executive leadership participation was required. They were educated on the need for clinical trials to be offered as part of state-of-the-art care and what it took to have a strong clinical trials program. The external evaluation included a business case assessment that had CEO and chief financial officer interviews, as well as data collection. The evaluation results showed a return on investment with improving trends for volume and market share as well as for physician alignment.
What comes as the biggest surprise about clinical trials when healthcare executives are truly educated on them as a business strategy?
The biggest “aha” moment is presenting an enterprise-wide picture of clinical trials across their organization. Even in academic medical centers, there is often more variation than they realize and mixed levels of performance, depending on the clinical area. There are also many clinical trials that are open with very low accrual, which means they are not reaching patients or realizing the financial benefit that is possible. For community hospitals, the biggest aha moment is helping executives realize that they can play an important role in advancing science and that their organizations are well positioned to have a strong clinical trials program. They appreciate having a specific road map on what they need to do to have a high-performing clinical trials operation.
Can you share a lesson from working with a hospital on developing a business strategy for clinical trials?
A lesson learned from working with hospitals is that they need help to develop a business case and return-on-investment analysis for investment in a clinical trials program. This is not so easy, as there are many factors to consider. Few organizations have done this, and it helps to provide a methodology and to engage their finance departments. We recently worked with an integrated delivery system on an enterprise-wide clinical trials strategy with a business plan, which we describe as a case study in our recent white paper. Part of their strategy was to partner for some of the research administrative services to enable the improved operation to be in place more quickly to benefit their physicians and their patients.
"Community hospitals are where the patients are, and we know that they can play an important role in advancing and accelerating research."
What is a common issue you’re seeing in hospitals that are integrating trials?
It is hard for most organizations to have a high-performing clinical trials program, and most don’t realize the extent of enterprise-wide support that is needed. When the operation is not “firing on all cylinders,” physicians get frustrated because it is too hard to offer clinical trials, pharma companies elect to pursue other hospitals with high-performing operations, patients don’t get access to trials and the financial performance is not what it could be.
Can you break down the areas that need to be given support for a high-performing clinical trials program?
We see four areas of common problems – the trial portfolio, the clinical trials infrastructure, the clinical practice culture and financial management. First, the process of determining the portfolio of trials is not always robust enough to have trials that match the needs and characteristics of the population, or to support accrual or financial goals. Second, some of the infrastructure challenges include processes for timely approval of trials by institutional review boards, and efficient budgeting and contracting.
Third, the clinical culture needed to support the time of physicians to accrue patients to trials, offer strategies to reduce the high turnover in clinical research associates (CRAs) and address the low accrual to open studies. Fourth, financially, there are often opportunities for improvement in processes for budgeting, invoicing sponsors, management of accounts receivables for trials and standardization of enterprise-wide financial reporting on trial performance.
You have a white paper on advancing diversity in clinical trials in the community setting. What can you tell us about that research and its impact?
The theme in our white paper is that all need to work together to strengthen the capacity of community hospitals to conduct clinical trials, which can complement the work traditionally done in academic medical centers. We discuss what is needed to build this capacity and what community hospitals, pharma and other trial sponsors such as academic medical centers, and others can do to support this goal.
Everyone in the clinical trials ecosystem needs to work to improve diverse accrual by engaging patients and building trust. We know that the main way to reach diverse populations and include them in research is by bringing clinical trials to where they live and receive their care.
What prevents hospitals from being able to accrue more diversely?
The biggest barrier is having a trusted provider who engages with these patients, given the high level of distrust of research by many diverse populations. This takes time, investment and effort on many levels and is currently getting a lot of attention from Congress and the administration as well as from advocacy groups.
Another barrier is that a patient who is accepted for a clinical trial has to be able to have their care paid for, either by their insurance company or out of their pocket. In many cases, a trial takes place at an organization that is far from home and work and out-of-network for patients’ insurance coverage. The trial sponsor may pay costs related to the trial specifically (e.g. the drug cost), but not for the cost for services that are the clinical standard of care that is associated with the trial (e.g. infusion of the drug, an MRI that would be requested if the patient was not on a trial, or a hospitalization). Many patients can’t afford that, which eliminates many lower-income and more diverse patients from participating. These challenges support the case for having clinical trials closer to where patients live, particularly close to where they have their insurance coverage.
What can industry be doing more of, to support the goal of more trials in more community settings?
Industry should direct more effort to expanding trials to the community setting. I recommend taking a hospital with high potential for accrual that may be struggling in this regard and really taking the time to understand the reason for the low accrual.
There are various issues that they may be facing. Does it take a long time to open a study because of insufficient Institutional Review Board, legal, contracting, budgeting or other staff? . Do they have trial budgets that are sufficient to cover the costs? What is the hospital doing to retain CRAs? What is their process for identifying patients for trials? Do the physicians have sufficient time to put the patient on a clinical trial with all the productivity pressure?
What would be the next step after identifying why a hospital isn’t being as successful as it could be?
Sponsors should try to better understand the provider environment, what it takes to have a high-performing program and what is required for a business case for the hospital or their clinical trials program. Sponsors can assess their trial budgets to see if they are sufficient to reflect the costs for hospitals. This is where engaging management is beneficial, as they control the resources.
One pharma company has funded a collaborative of cancer programs serving diverse populations to facilitate the sharing of best practices, which is something others might consider.
Why are you so passionate about integrating clinical research into community hospitals?
If the large majority of patients receive their health care in the community, how can we advance science if we don’t tap into the potential of community hospitals to bring trials to more patients? Research today needs access to large populations to match patients to trials, and patients want access to trials, but we don’t have a health care delivery system that’s aligned to advance research.
I’m passionate about helping expand capacity for clinical trials to create more opportunities for patients and diverse populations. Community hospitals are where the patients are, and we know that they can play an important role in advancing and accelerating research.
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