This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
Approximately two-thirds of the NCI Community Oncology Research Programs, serve states in which the rural population exceeds 30%.
Besides the existential challenges of battling cancer, rural cancer patients have the additional issues associated with obtaining increasingly complex cancer diagnostic tests and treatment.
Heartland Cancer Research, our NCORP, is among those programs striving to provide rural patients access to outstanding care through the vehicle of NCTN treatment, cancer control, and cancer care delivery trials.
Focusing on geographically disadvantaged patients
The SARS-CoV-2 pandemic has magnified pre-existing inequities in access and affordability of care, particularly for poor and underserved populations.
Telehealth and video visits are useful, but have limited availability in some rural settings, further isolating those who are medically underserved because of geography.
Nonetheless, the option of conducting informed consent processes and remote visits enables NCORPs like ours to maintain contact with some patients and conduct research-related functions with prudent social distance.
Workflow during the pandemic
Working remotely has complicated operations significantly. Staff had to adapt to alterations in work hours, workload and workflow, revise communication processes, and devise new ways to interact with patients and health providers.
Even routine tasks became more time-consuming. Institutions furloughed and repurposed staff due to COVID-19, further impacting efficiency. Concern that these staff changes will be permanent added a further level of stress.
NCI and NCTNs responded quickly to COVID-19 by halting new clinical trial activations and showing flexibility for current study participants with respect to study calendars, follow-up visits, and remote consenting processes.
There was latitude in allowing local providers in remote communities to conduct protocol-mandated visits, with the oversight of the investigator responsible for that patient’s study-related care and documentation.
Unfortunately, there was confusing and contradictory information distributed early in the pandemic, particularly regarding remote HIPAA requirements and processes for tele-consenting. The ambiguity compromised our ability to assure patients that their cancer care was under control.
The loosening of regulations allowed institutions to implement adequate social distancing measures to protect patients and staff without sacrificing scientific rigor necessary to preserve primary endpoints.
Of necessity, this required tracking all major and minor deviations to studies and ascertaining their relationship to COVID-19.
Regrettably, each NCTN developed individualized approaches and methodology. At the receiving end of these guidelines, the NCORPs suffered from lack of continuity among the NCTN groups’ formats for documenting COVID-19-attributed deviations.
The burden of tracking data in RAVE continues to be a challenge for staff. Each research base collects data differently in RAVE. This makes training new staff laborious and time consuming. Data quality reports only provide overdue data lists rather than a future expectation report.
Errors in forms and queries are difficult to find in RAVE, requiring multiple calls and emails to NCTN study coordinators. Submitted data are noted as “delinquent” when the data have already been submitted.
As a result, staff must double- and triple-check RAVE, since errors impact an NCORP’s membership status in the NCTNs. To complicate matters further, some older studies still require NCORPs that formerly participated in the NCI’s Community Clinical Oncology Program to enter data into the old cooperative group systems.
Biospecimens and investigational agents
NCORPs like ours are completely supportive of the need for biospecimen acquisition in cancer research studies, but redundant processes make tracking of biospecimens unnecessarily burdensome.
A specimen must be collected and entered in each research bases’ own specimen tracking system, as well as into the RAVE and OPEN systems.
Duplication of effort and incoordination of data-sharing among systems transitioned from being annoying to becoming unrealistic as staffing modifications and work-from-home requirements hit NCORPs during the coronavirus crisis.
NCTN tasks are increasingly shifting to the sites without additional funding. For instance, while we were contending with the coronavirus crisis, for A221701, one of the NCTN groups asked sites to rebottle liquid formulations of the study drug/placebo and relabel for patient distribution.
For NCORPs like ours, with sites of operation scattered across several different states and in many small communities which have limited staff able to appropriately handle investigational drugs, this is a logistical nightmare.
Opening new studies
Many new protocols have the same requirements as pharmaceutical company studies, without comparable reimbursement.
Although the CIRB has helped in study approval, there are no additional resources for training investigators and CRAs, for building protocol treatment plans in the EMR, or for developing the internal source document worksheets used for eligibility and toxicity evaluations. In short, NCORP grants have no start-up funds.
Nonetheless, new studies have considerable regulatory expectations, mandatory and/or optional biospecimens, equipment credentialing, site personnel training,
Delegation of Task Logs, or DTLs, and site monitoring (outside of usual NCTN audit cycles). These requirements increase the demands on staff, add administrative responsibilities to our community-based investigators, and lengthen the time required to open a study.
DTLs are particularly burdensome for large networks such as Heartland Cancer Research because multiple institutions require a separate DTL for each site even when the staff are the same at these sites.
The DTL program oversteps what is required by pharmaceutical FDA registration studies that allow blanket delegation logs. The current DTL system needs to be streamlined with input from the end users.
Scientific progress has led us away from performing larger studies.
Local costs of implementing a new study are estimated to be more than $10,000 and are more easily justified when the cost can be spread across a larger enrollment of patients per study.
The transition to studies targeted to small subsets has especially disadvantaged rural cancer patients, since no clinical trials are available for many of the people who have come to rely on us for access to clinical research.
For NCORPs like ours, it is increasingly challenging to accrue large numbers of participants and fulfill our mission to the communities we serve.
Insurance coverage among the newly unemployed
The future of insurance coverage for vast numbers of patients in the country is now uncertain with many newly unemployed people losing their health insurance and with the continued efforts to weaken the Affordable Care Act. What impact any new health care laws will have on clinical trial participation is unknown.
Even the ACA did not guarantee clinical trial coverage, even for routine costs. Among companies that do not pay for any patient charges on clinical trials are the VA and several of the Labor Funds under Blue Cross/Blue Shield. In Illinois, the state employees’ insurance coverage does not allow clinical trials participation.
Illinois has moved most of their Medicaid patients to Advantage Plans. Medicaid Advantage plans are not required to cover clinical trial participation, so they can deny any costs related to clinical trials. In addition, certain large insurance companies can take weeks to pre-approve clinical trial participation for their clients. The physician and the patient do not feel they can wait that long to start treatment, so patients decide against clinical trial participation.
Insurance-related issues consume valuable personnel resources in what eventuates in a futile pursuit of insurance coverage approval. As a result. patients are not receiving the optimal care afforded by clinical trial participation.
For example, S1501 requires echocardiographic validation. When insurance for a study patient requires the patient to receive echocardiograms only at non-credentialed institutions, it becomes impossible for a patient to participate, because we cannot validate echocardiograms at every possible institution. This has happened at our NCORP.
Our most valuable and consistent resource: People committed to our mission
Workloads at our NCORP component sites are heavy and increasingly complex. Clinical research personnel have left their jobs because of expanded responsibilities, increasing study complexity in the absence of commensurate compensation or professional recognition.
Institutions are hesitant to increase salaries or add additional staff because of the instability of federal funding over time.
Finding qualified individuals to fill open positions has always been a challenge. Experienced research nurses, clinical research associates, and regulatory personnel are not abundant in the available workforce in a predominantly rural area, and it takes considerable time and expertise to train new staff members.
Despite extensive training and consistent mentoring, we expect it to take more than a year before a research nurse or clinical research associate is operating at full capacity.
Despite the obstacles and challenges stated above, NCORPs like ours remain fully committed to our worthy mission, to bring access to state-of-the-art clinical research to medically underserved populations near where they live and work.
Physician engagement remains high among NCORP investigators, and we are confident that investigators and staff will adapt to the additional challenges that the coronavirus pandemic has posed.
