Even as pandemic recedes, short-staffed trial sites leave cancer patients waiting

In the early days of the Covid-19 pandemic, when many trials were grounded, Jason Luke and his fellow clinical researchers at the University of Pittsburgh Medical Center were still testing new cancer drugs in 50 Phase I studies. Now, his colleagues only have the bandwidth to handle one-fifth the amount of early-stage trials as they did in early 2021.

The issue became stark eight months ago. “Wait a minute, everybody stop,” he recalls interjecting his colleagues’ conversation during a weekly team meeting around the beginning of 2022. They were discussing how 36 patients were on the waiting list for clinical studies but UPMC’s cancer trials apparatus could only take in one to two patients per week, about one-fourth the volume as compared to last year.

Jason Luke

The delay befuddled Luke, who directs the Cancer Immunotherapeutics Center at UPMC’s Hillman Cancer Center. He says “on a human level” it tore at him that the number of patients seeking new treatments didn’t let up.

As patients with life-threatening cancers wait for new therapies, trial operators across the US struggle to staff their sites with adequate workforce to meet demand. The intensifying staffing shortages started before the Great Resignation that befell many industries.

Some academic researchers and industry leaders have billed it a crisis, compounded by the influx of therapeutics entering the clinic and as the sheer amount of drug developers has skyrocketed in the past decade. The number of biopharmas with active pipelines is about 4.5 times what it was in 2001, according to an Informa Pharma Intelligence tally.

At one Chicago institution, the shortage has upended studies. In late June, Rush University began temporarily pausing enrollment of new patients in clinical trials in its cancer center, a spokesperson confirmed to Endpoints News via email, saying the halt is “like so many institutions across the country” because of a scarcity of cancer-focused clinical research coordinators. The spokesperson didn’t answer questions about how many studies paused enrollment but said patients who were previously screened and consented can still be enrolled or be sent to another institution conducting the same trial.

The problem is particularly acute in oncology because of the complex trial designs and the large variety of tumor and cancer types. The amount of people directly impacted by cancer also factors into the equation: The American Cancer Society estimates 1.9 million new cancer diagnoses this year and more than 600,000 deaths.

Oncology has been one of biopharma’s key R&D areas for years. Researchers began 2,335 new trials last year of oncology therapies, according to IQVIA.

While only about 1 in 20 cancer patients will take part in studies of new therapeutics, clinical trial sites haven’t been able to keep up with the amount of people seeking new treatments that hold the potential for extending and saving their lives.

Tanios Bekaii Saab

Cancer centers have been “bleeding personnel,” partly because of lower pay in academia than industry, says Tanios Bekaii-Saab, leader of Mayo Clinic’s gastrointestinal cancer program, which overburdens existing staffers. The revolving door of new nurses and clinical research coordinators means institutional memory is lost and replacements take as many as six months to get brought up to speed. Meanwhile, work-life balance is hard to achieve.

Within the 300-trial clinical research unit at Abramson Cancer Center at the University of Pennsylvania, the shortage has sometimes impeded the institution’s goal of 90-day trial activation timelines, says medical director Dan Vogl.

Dan Vogl

“We pretty much lost the capacity to conduct research efficiently over the last year, year and a half, and likely for another half to a year, so these are lost opportunities,” says Bekaii-Saab, who is also a chair of medical oncology in Mayo Clinic’s hematology/oncology division.

Not all staff are leaving for industry; some nurses simply want to fulfill their calling. “Nurses love to do what they want to do. They want to be nurses, they don’t want to be research coordinators. So it’s very difficult to essentially convince nurses to remain in research,” he says.

The issues escalated to the point that oncologists, biopharma executives and CROs convened in August to discuss the “Crisis in Clinical Research,” as the virtual summit was titled. The Society for Immunotherapy of Cancer gathered 900 attendees representing biotech, clinical trials, government and regulatory institutions, according to executive director Mary Dean.

Mary Dean

Investigators and industry leaders point to wage discrepancies between jobs at academic trial sites and within biopharma or clinical research organizations as one reason driving the exodus. Increasing the pay at academic institutions would be an obvious answer, but public universities tend to maintain strict budgets, unlike the more fluid capital flow within Big Pharma and well-funded biotech startups.

“You don’t really have the control to say, ‘I have the money to hire more people,’ because that’s not the way it works in an academic center,” says Mario Sznol, who’s been investigating new immunotherapies at Yale since 2004. “That’s all done through a central office.”

Multiple clinical trial administrative leaders declined interviews.

Luke, at UPMC, says that on a personal level, he believes the research community has been “undervaluing” the contributions of many workers. “We just took it for granted we had coordinators and nurses,” he says. “We probably really need to rethink how we compensate them and how we appreciate them.”

Jeffrey Meyerhardt

The staffing shortage also arises from the mental toll that nursing and clinical research can take on a person, particularly during a pandemic, according to investigators and industry insiders. Some staffers view clinical research roles as stepping stones on the path toward nursing, medical or social work school, says Jeffrey Meyerhardt, chief clinical research officer at Dana-Farber Cancer Institute.

There’s also a paucity of people in the workforce to take up the positions. The ratio of job postings for clinical research coordinator to those looking for a job is 7:1, and climbs to 10:1 for nurses, according to the Society for Clinical Research Sites. And many job postings ask for two years of experience for entry-level positions, which serves as another barrier, per the Association of Clinical Research Professionals.

Susan Landis

The clinical research job gap can in part be attributed to the lack of promotion around the profession, says ACRP executive director Susan Landis, who says it’s a unique community that is “very much a hidden profession” not specifically carved out as a subindustry by the Bureau of Labor Statistics.

Sznol says the shortage has existed for years. He’s long seen staffers move over to industry, but the issue has become a “major problem” in more recent years. He says institutions tend to understaff trials. Phase I, or first-in-human, studies typically require more staffing because of the intricacies involved in figuring out the therapies’ safety, he notes.

“The usual approach is, when you have more accrual, we’ll hire more people, but the problem is that it doesn’t work that way because you have to have the research personnel in order to increase accrual,” Sznol says.

Getting short-term staffing acts as a Band-Aid that can drain finances. Hiring for short-term roles can be “two-to-fourfold over regular expenses,” Suresh Ramalingam, executive director of Winship Cancer Institute at Emory University, said in a spring ASCO report.

One R&D leader at an oncology and infectious diseases biopharma, which markets a cancer drug, says his company has set aside money in their budget to help sites hire more staff. But sometimes throwing money at the problem is not that simple.

David Feltquate

“What the sites tell us is, ‘Thank you, that’s a great idea,’” says the biopharma exec, who spoke on the condition of anonymity, noting sites tell him they’ve received similar offers from additional companies. “But the way the infrastructure is set up at the site, so if we’re doing a melanoma trial, we can’t give money to the melanoma group to hire people. The money goes to a central fund, and they said, ‘If that money goes there, we’ll never see it.’”

While the issues have mounted, people across the clinical trial ecosystem have worked “really, really hard, despite all of this, to get it to work,” says David Feltquate, CMO at Palleon Pharmaceuticals.

Feltquate and Atreca CEO John Orwin say their biotechs have tried alleviating the situation by adding more sites to their Phase I programs, both around a dozen, as compared to a historical approach of eight, according to the Palleon exec. With more sites in tow, the workload spreads out. Atreca also no longer takes doctors’ work of identifying patients for trials for granted, ensuring its trial is front and center for site investigators.

“In the end, if higher costs and more time to actually execute, all that means it’s harder to find the drugs that work and get them to patients. That should be enough motivation for everyone to do better here,” Feltquate says.

No easy solution 

Some institutions have seen their attrition rates start to improve already, like Penn’s Abramson Cancer Center clinical research unit decreasing from 30% last year to 18% so far in 2022, according to Vogl, the medical director.

Darlene Kitterman

Penn, Dana-Farber, the University of Illinois Cancer Center (UICC) and others have adjusted salaries for existing staff and increased pay for open positions after going through benchmarking analyses to make salaries more level and competitive with the market, leaders say. UICC analyzed information from other institutions, like Oregon Health & Science University, and then reallocated money from its operating budget to the Clinical Trials Office to raise pay, says administrative director Darlene Kitterman.

That’s one piece of the solution, but not one that has been implemented across the board.

Vogl’s unit has teamed up with staffing agencies to recruit people. They’ve also beefed up their training program, which includes an intensive series that begins with a “Clinical Research Education Week” and then a slate of lectures and follow-on meetings, he says, noting 19 of 142 staffers are currently going through the process.

“A lot of the staff that we are recruiting are extraordinarily talented people but who don’t have a lot of experience in either cancer or clinical research or sometimes even both, which means that there are a lot of knowledge and skills gaps that they have to make up, which is why it’s even more important that we have these robust training programs,” he says.

John Orwin

Orwin says the challenges will remain and that industry would benefit from collaborations with sites and nursing societies, potentially around the likes of a certification program. On the clinical research side, two organizations offer accreditation: ACRP and the Society of Clinical Research Associates, according to Landis, the ACRP leader.

“I don’t have the answer, I just know that it’s a challenge that applies to almost every company that’s involved in clinical development and, to the effect that it could potentially delay the time to developing and approving life-saving therapies, it’s really important that this be a high priority,” Orwin says.

Solutions could also entail shifting responsibilities and tasks among trial sites and CROs, researchers and industry leaders say. Or, making more roles permanently remote, like data entry and collection staff.

Deploying staff more efficiently is another tactic. Dana-Farber took a program that its bone marrow transplant group had piloted half a decade ago and asked all departments to implement it this year to be more judicious about staff allocations during the shortage, Meyerhardt says.

Attrition has gone down, he says, as the program allows teams to “appropriately create a portfolio that matches what our staffing is” across 100-plus lead investigators working on more than 600 open studies, he adds.

Institutions must also become better at creating clear job paths that have promotion opportunities and career development baked into the system, leaders say. Career ladders are “what folks want,” says Bekaii-Saab, the Mayo professor, emphasizing research must be valued, but so must every person involved in the studies.

Meanwhile, in Chicago, UICC has been in a growth spurt and hiring quickly as it applies for National Cancer Institute designation, Kitterman says. In addition to raising pay, UICC revamped job descriptions to set a blueprint for career development paths.

Kitterman characterizes the center’s current system as “very equitable” with clear job paths in place. Also fueling the staffing increase is the institution’s focus on serving “a very diverse and somewhat underserved population in the Chicago area,” a mission that has attracted staff and been a boon to industry collaboration, she says.

Partnerships among organizations will be key. The American Society of Clinical Oncology and SITC are engaging on potential next steps after last month’s SITC summit on the “crisis,” says ASCO chief medical officer Julie Gralow. Summit organizers and partners will collect data on trial activation timelines to “understand where the bottlenecks are in the system so that when we start to propose solutions,” says Dean, the SITC executive director.

Fixes will require buy-in from industry, institutions, individual investigators and associations, says Luke, the clinical trials leader at UPMC.

“We’re going to have to just really rethink how all of this works because it currently is just treading water, not moving forward,” he says.

Marc Ernstoff

Marc Ernstoff, a five-decade researcher and branch chief of immuno-oncology at the National Cancer Institute, says the improvement process “will probably last for a number of years.”

As the solutions start trickling in, challenges will remain, particularly a conundrum around budding mountains of data and documentation. Staff and investigators already have a hefty workload — recruiting and treating patients, coordinating new studies, and answering cold calls and emails from eager sponsors looking to start trials — but on top of all that is the data collection that limited workforces are required to handle.

Mario Sznol

Study documentation has also ballooned. Synopses today are almost as long as full protocols in the past, says Sznol, the Yale investigator. Vogl, the medical director of the Clinical Research Unit at Abramson Cancer Center, shares an anecdote of his staffers spending hours searching for the date of patients’ onset of hypertension, required by the study sponsor but which has “zero impact on the overall results.”

Requests like that, he says, “creep into the study database by tradition and inattention.”

Then there’s the strict scrutiny between contracts and consent forms, and when a one-line change about a travel stipend isn’t fixed on both ends, it can throw a wrench in the speediness of treating patients, Sznol says.

“And you think, ‘Gee, is that really the most important thing that we have to worry about for a patient who has advanced metastatic disease?’” says the clinical investigator. “These are the sorts of things that drive me crazy.”

Editor’s note: Endpoints News is looking to hear from you about your experiences with clinical trials. Please fill out this form to contribute your story.

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