Workforce shortages have been on the horizon in health care for decades, but in the years since the start of the COVID-19 pandemic, the future is now. Staffing shortages are affecting the entire health care sector, but there’s a particular strain being felt in clinical trial offices that has the potential to curtail scientific advances for years to come.
“Workforce shortages are affecting efforts to conduct clinical research in hematology at all levels,” said Mikkael S. Sekeres, MD, chief of hematology at Sylvester Comprehensive Cancer Center, part of the University of Miami Health System in Florida.
The U.S. Bureau of Labor Statistics cited a record 4.5 million workers quitting or changing jobs in November 2021. Health care and social assistance were among the industries with the largest increases in turnover.1
In the hematology-oncology arena, one study estimated a 60% decrease in the launch of oncology clinical trials during the five-month period from January to May 2020.2 Going into 2021, the initial drop-off in enrollments seemed to rebound, with actual enrollments at about 75% of what was expected. The largest decrease occurred in cancer control and prevention trials as compared with treatment trials.3
ASH Clinical News spoke with Dr. Sekeres and other research staff and physicians at cancer centers throughout the U.S. to discuss the realities of “The Great Resignation,” the nuances of this labor shortage to hematology-oncology research, and how it may affect patients and scientific advances in the future.
One major change that COVID-19 brought to the workforce was the switch to telecommuting. Even before the pandemic, though, many hematology-oncology research groups were already exploring whether allowing employees the flexibility of working from home would be a viable way to retain staff.
“It was well-recognized that there was a shortage of people who conduct some of the nuts-and-bolts roles of clinical trials,” Dr. Sekeres said.
Certain positions, like research coordinators, tended to be people just out of college who were either seeking a permanent career in clinical research or a temporary position as they figured out what they want to do, he said. So, turnover wasn’t uncommon before COVID, but then it sped up.
With the pandemic, clinical trials were affected in a variety of ways at the University of Alabama at Birmingham’s (UAB’s) O’Neal Comprehensive Cancer Center, according to Amitkumar Mehta, MD, associate professor and director of the lymphoma program at UAB and medical director of the Clinical Trials Office.
Initially, there was no staff shortage, he said, but several factors contributed to an eventual shortage of team members. Trials were slowed as the center adjusted to new COVID-19-related restrictions and set up more virtual visits. When the waves of patients with COVID-19 hit, the hospital reallocated resources to focus on managing patients who were infected.
“That included everything from finances, to floors of the hospital, staffing, and assignments of specialists,” Dr. Mehta said. “Oncology clinical trials were not a top priority at that time.”
Then, new clinical trials were initiated to research COVID-19, he added. The institutional review board and clinical trial operations committees prioritized these trials, and other trials were forced to slow down.
“In the past year or so, many staff have acquired COVID-19, some took early retirement, others had their priorities change,” Dr. Mehta said. “We had staff departures from the clinical trials offices that impacted trial operations.”
This issue was not isolated. In fact, the Association of American Cancer Institutes’ (AACI) Clinical Research Innovation program convened a Clinical Trials Office Staff Retention Task Force to begin to address this problem and gather information on strategies to help cancer centers regain staffing stability.4
Any clinical trial office includes patient-facing and non-patient-facing staff, and staffing stability involves both. When asked to quantify staff shortages, Megan Kilbane, MBA, the cancer research program administrator at Cleveland Clinic in Ohio, said the greatest impact was related to loss of registered nurses (RNs).
“These are licensed, patient-facing positions,” Ms. Kilbane said. “This loss did not only occur here; it has happened all across the county. We are losing RNs.”
Ms. Kilbane said that among other things, Cleveland Clinic lost a number of RNs to the booming travel nurse industry, which can offer more flexibility and higher pay.
According to an article in The New York Times Magazine, listings for travel nurses boasted salary ranges as high as $8,000 to $10,000 per week or more. In contrast, the average annual salary of a staff nurse in Texas, for example, is about $75,000.5
The whole situation created a catch-22 of sorts, with hospitals then forced to hire from travel nursing agencies and, consequently, pay more for help.
“It is a need of its own creation,” Dr. Sekeres explained. “Travel nurse agencies existed in the past and filled a need when shortages came, but the shortages we are seeing now are, in part, caused by the phenomenon of travel nurses.”
Ms. Kilbane said that filling RN positions at her institution has been very challenging and that they have about seven open spots at any given time out of 30 full-time positions.
The Cleveland Clinic’s leukemia and myeloid disorders program research group is also struggling to keep its five RN positions staffed, noted Kate McCaffrey, MBA, the cancer clinical research administrator.
“We have had three people in and two vacancies,” she said. “It took about six months to fill one vacancy. Once filled, unfortunately the candidate decided it was not a good fit and left within two months. The other position we have never been able to fill.”
Similarly, Renee Rakvica, RN, OCN, director of site services for US Oncology Research, also noted that RN positions have been difficult to fill, so her team chose to expand the field of potential applicants.
“In oncology, you are looking for oncology and a research background. The pool is slim,” Ms. Rakvica said. “Now, we are left considering anyone who is a nurse and have decided we will train them.”
Institutions are also struggling to fill patient-facing, non-licensed, clinical research coordinator positions. These professionals carry out tasks such as preparing lab kits for patients to have electrocardiograms.
“We lose almost all of these people externally,” Ms. Kilbane said. “Some go to pharmaceutical companies, a lot go back to school, and some are medical students who come to get some experience and then move on.”
The non-patient-facing staff positions have been hardest to keep filled at the Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, according to Christy Spalink, DNP, director of clinical operations for the Clinical Trials Office. Dr. Spalink said they are facing unprecedented challenges filling these positions but acknowledged that these challenges are not nearly as severe as those at other centers.
Dr. Spalink’s colleague Ankeeta Joshi, director of administrative operations for the Clinical Trials Office at Perlmutter, said that prior to the pandemic, pharmaceutical companies were always competition, but the positions at NYU had an advantage because they did not require travel.
“With the pandemic, that leverage was no longer there as [all of] these positions became remote,” Ms. Joshi said. “We have worked hard to provide strong compensation and benefits to our positions, including allowing full-time remote.”
These initiatives have paid off, as both the Regulatory Affairs and Data Coordination Units now have less than a 10% vacancy rate.
At Cleveland Clinic, Ms. McCaffrey said that within the leukemia and myeloid disorders program there are about 12 regulatory positions, and they have a 30% vacancy rate. At any given time, they are turning over three or four of those positions.
“It is difficult. We hire young professionals with a degree and a little experience, and we train them to be a coordinator,” Ms. McCaffrey said. “We help them gain an understanding of the role of a coordinator and then pharma will say, ‘They are great!’, and give them a huge raise and allow them to go fully remote.”
The Research Slow Down
Many cancer centers are justifiably proud of how they quickly adapted to the pandemic and kept enrolling patients in clinical trials, but the challenges that started in March 2020 – although they are changing – have remained steady for the past two years.
“There are delays in opening trials because there isn’t person power to advance the trial through the regulatory hurdles they have to go through in order to open,” Dr. Sekeres said. “Once a trial is open, there are holds on enrollment because there is not enough clinical research staff to manage patients.”
Janice M. Mehnert, MD, associate director for clinical research at the Laura and Isaac Perlmutter Cancer Center, reported seeing new challenges with quick staff turnover, not only at academic campuses but in industry as well.
“We haven’t had to put patient accrual on hold, thankfully,” she said. “We have always asked ourselves the hard questions about which trials are the most important priorities, and that is more important now than ever.”
Prioritization is a focus each week at US Oncology Research as well, Ms. Rakvica said.
“We have to focus on the patients coming that week. We look at the distribution of workload and what is a high priority,” she added. “We look at data deadlocks, at interim analyses, and at which trials have active treatment patients that will have monitoring visits.”
An accrual hold is the last resort for a practice, but if needed, Ms. Rakvica said they are open with trial sponsors and develop a plan.
“We send letters explaining the reasons,” she said. “We want the focus to be on quality data and the existing patients’ care. We evaluate for re-opening every 30 days.”
In 2020, Cleveland Clinic actually had higher trial accrual than it did in 2019, but 2021 has lagged behind, Ms. Kilbane said.
Cleveland Clinic is still able to offer a “full portfolio” of trials for all patients coming through the door, Ms. McCaffrey said, admitting that there may be some frustrated principal investigators who aren’t seeing trials move forward as quickly as they would like.
“I don’t feel like we have significantly contributed to an overall research slowdown,” Ms. Kilbane said, “but we may be pulling back the reins on what our potential could be.”
The Effect on Patient Care and Progress
The biggest cost of the staffing shortages is not being able to offer trials to patients, Dr. Mehta said.
“We want patients to benefit from novel drugs or agents, especially when they are struggling clinically, mentally, personally, or financially,” Dr. Mehta said. “If they are not able to go on a clinical trial, there is a massive effect on patient care.”
Taking a wider view, Dr. Sekeres worried about the ripple effects of even just a couple of years without growth, especially given the years of research required between an Investigational New Drug application that is filed when a clinical trial is initiated and a New Drug Application, which is submitted for that drug’s potential approval.
Specifically, President Biden recently re-launched the Cancer Moonshot initiative, now called Cancer Moonshot 2.0, with the a goal of reducing the death rate by at least 50% in the next 25 years.6 In an editorial published in The Hill, Dr. Sekeres wrote that “the paucity of patients enrolling to cancer clinical trials . . . could delay by years the introduction of those exciting new treatments or cancer prevention strategies referred to in the administration’s initiative – the drugs that could help reduce the cancer death rate.”7
“Victories [that the Moonshot] is going to want to claim for patients aren’t going to be realized if we can’t get patients on trials,” Dr. Sekeres said.
For example, Dr. Sekeres has an investigator-initiated trial that he opened at University of Miami, with five other National Cancer Institute-designated cancer centers that have agreed to sign on.
“At least three of them have gotten back to me saying that it will be months to a year before they can open the trial, due to either research coordinator or nursing shortages,” Dr. Sekeres said.
“We have incredibly innovative ways of identifying lead compounds and substances that may work to cure cancer and hematologic conditions,” Dr. Sekeres added. “Those need to be translated into trials with people, and if we don’t have the infrastructure to conduct those trials, that progress isn’t going to happen.”
Members of the American Society of Hematology’s (ASH) Clinical Research Training Institute (CRTI) Steering Subcommittee have been discussing strategies to successfully address staffing issues since the pandemic began, according to Allison King, MD, PhD, professor of pediatrics, hematology, and oncology at Washington University in St. Louis School of Medicine and chair of the CRTI subcommittee.
“We had senior clinical investigators and junior clinical investigators who were able to share on a regular basis what was going on and provide feedback about possible solutions to overcome these ‘speedbumps’ in clinical research,” Dr. King said.
One thing that seems to have been universally discussed is compensation.
At Cleveland Clinic Cancer Center, Ms. Kilbane said a formal compensation review took place in December 2021. The center currently offers a hybrid schedule for non-patient-facing positions and is exploring this possibility for patient-facing positions.
“We looked at compensation, but pharma will always be able to pay more,” Ms. Kilbane said. She added that an added benefit her staff experiences is being part of a team that interacts directly with patients.
The proposed hybrid model will allow people to see colleagues and conduct patient care in person, while also allowing for that concentrated time at home, Ms. Kilbane said.
Ms. Rakvica said that US Oncology Research has instituted sign-on bonuses and retention bonuses but recognizes it still may not be able to compete with pharma companies. As an alternative way to appeal to candidates, Ms. Rakvica said they have examined growth opportunities within the network.
“A coordinator may come in and think, ‘What else can I do?’” Ms. Rakvica said. “We may not be able to change their title, but maybe we insert them as lead on a project that they are interested in or find another way to make them feel valued as an individual.”
US Oncology Research is present at 60 sites with 160 office locations in the U.S. This size means that candidates can be presented with a wider network of opportunities.
“I try to provide them with those types of possible advancement opportunities up front,” she added.
Another potential strategy revolves around the difference in culture between a pharmaceutical company and an academic center. For example, UAB has been working on growing that culture by making connections between research staff and patients.
“We are trying to connect the two worlds of patient data and patient stories,” Dr. Mehta said. “Connecting those two worlds increases the meaning of the work.”
Dr. Mehta said UAB is also focusing more on its staff as people.
“Things are stressful right now with COVID and everything else going on in the world,” Dr. Mehta said. “We have to be offering support, teambuilding, and improving culture. We are looking to improve things with a holistic approach.”
This approach has several components at UAB. Salaries in the Clinical Trials Office were increased this year, and the group is looking into hybrid models that will allow some team members to work remotely.
“The plan is to try one or two models and see which one is efficient and less stressful,” Dr. Mehta said.
The group is also planning a retreat for the clinical office team and investigators. This will not only provide social interactions but also allow the group to talk about challenges, share experiences, and propose solutions.
Team exercises are being planned, too, to gain a better understanding of team members’ work styles and perspectives. Dr. Mehta stressed that the clinician’s role in that team is immense, and it includes both needing and providing support.
Many of these approaches were echoed in a Commentary editorial from AACI in which Kristie Moffett, senior director for human subjects research at Moffitt Cancer Center, detailed the strategies employed to reduce turnover there by 10%. These included being flexible, engaging the team, expanding the career ladder, and listening to team members. However, Ms. Moffett noted that each center will have to find the right combination of these strategies to find success.4
The search for that secret to success will be ongoing as the world of clinical trials – and the world itself, really – will never be completely the same as it was before the COVID-19 pandemic.
“Things were beginning to change before the pandemic, and now we are seeing it is not going back,” Ms. McCaffrey said. “This shift is going to remain, and we can either shift with it or fall behind.”
—By Leah Lawrence
1.S. Bureau of Labor Statistics. Number of quits at all-time high in November 2021. TED: The Economics Daily. January 6, 2022. Accessed March 28, 2022. https://www.bls.gov/opub/ted/2022/number-of-quits-at-all-time-high-in-november-2021.htm.
2. Lamont EB, Diamond SS, Katriel RG, et al. Trends in oncology clinical trials launched before and during the COVID-19 JAMA Netw Open. 2021;4(1):e2036353.
3. Unger JM, Xiao H, LeBlanc M, Hershman DL, Blanke CD. Cancer clinical trial participation at the 1-year anniversary of the outbreak of the COVID-19 JAMA Netw Open. 2021;4(7):e2118433.
4. Moffett K. Repairing damage to clinical trials office staffing. AACI Commentary. March 2022. Accessed March 31, 2022. https://www.aaci-cancer.org/Files/Admin/Commentary%20Archive/2022-March-AACI-Commentary.pdf.
5. Hilgers L. ‘Nurses have finally learned what they’re worth.’ The New York Times Magazine. 15, 2022.
6. The White House. Fact Sheet: President Biden reignites Cancer Moonshot to end cancer as we know it. February 2, 2022. Accessed April 8, 2022. https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/.
7. Sekeres MA. COVID and the Cancer Moonshot. The Hill. 15, 2022. Accessed April 8, 2022. https://thehill.com/opinion/healthcare/594199-covid-and-the-cancer-moonshot/.
ASH Works to Fund Future Hematology-Focused Fellowships
For several years, the American Society of Hematology (ASH) has been conducting a national, longitudinal study of the hematology workforce. One of the first recommendations to come out of the study was to increase the number of hematology-oncology fellowship programs designed to prioritize training and careers in hematology.
In response, ASH has created the Hematology-Focused Fellowship Training Program (HFFTP), which is funding the creation of 10 new innovative hematology-focused fellowship tracks within existing adult hematology-oncology training programs. ASH received more than 20 applications in response to the request for proposals and is sponsoring eight institutions for one new fellowship slot per institution and one institution for two new fellowship slots for five cohorts at each sponsored institution, producing 50 new academic hematologists by 2030.
The goal of this innovative program is to enhance recruitment of internal medicine (and medical-pediatric) residency graduates and to retain them in life-long subspecialty careers focused on academic, multidisciplinary, classical (non-malignant), or malignant hematology. Multidisciplinary, classical hematology may pair traditional training with career-enhancing opportunities such as transfusion medicine, sickle cell disease, or hemostasis/thrombosis or a broader academic emphasis such as medical education, systems-based hematology, or outcomes research.
Institutions had to have a well-established fellowship program with a track record in training classical and multidisciplinary hematologists in order to apply. In March, ASH informed the awarded institutions of their selection. Awarded institutions will receive funding for assistant program director positions starting July 1, 2022, with the first cohort of hematology-focused fellows starting July 1, 2023. Selected institutions will be made public in July.