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This content is from the “Advancing the Science of Cancer in Latinos: 2024 Conference Proceedings.”
Adapting NCI’s Clinical Trials System to a Changed Clinical Research Environment
Dr. James H. Doroshow is Deputy Director for Clinical and Translational Research at the National Cancer Institute (NCI).
This plenary session occurred at 8:30 am., Thursday, Feb. 22, 2024, at the 4th biennial Advancing the Science of Cancer in Latinos conference.
COVID’s impact on cancer clinical trials

Dr. Doroshow’s presentation began by discussing the initial and continuing effects of the pandemic environment on cancer clinical trials. From the start of the pandemic, several aspects of clinical trials were altered, including informed consent and in-person study activities. One major ongoing issue is the critical shortage of research nurses, clinical research associates, and research office regulatory staff, as well as essential health care workers and institutional central research service workers. These shortages have diminished trial availability and accrual, including for underserved populations, and led to substantive delays in results reporting. Monthly enrollment in treatment trials at National Cancer Institute (NCI)- designated cancer centers also decreased drastically in early 2020. As a matter of fact, annual enrollment is still down about 25% compared with 2019 enrollment.
In response to this decrease in enrollment, the NCI launched the Cancer Center Clinical Trials Workforce Survey to assess the ongoing impact of the COVID-19 pandemic on the capacity of Cancer Centers to conduct treatment trials. The survey was administered by the Science Technology Policy Institute (STPI) and had a response rate of 100% of clinical cancer centers. Results of the survey showed that one major impact on accrual was limited research staff capacity, preventing openings and forcing accrual holds. This loss of personnel was largely associated with research staff leaving for the higher pay offered by pharma companies and clinical research organizations (CROs), who offered higher compensation to insulate themselves from pandemic-driven staff shortages.
NCI’s vision for clinical trials
In response to these issues, the NCI’s Clinical Trials and Translational Research Advisory Committee (CTAC) developed a 2030 Vision for Clinical Trials to re-assess the strategic vision for the clinical trials system for 2030 and beyond. The CTAC developed 15 recommendations and 3 operational initiatives to develop more flexible, faster, simpler, less expensive, and more high-impact clinical trials that seamlessly integrate with clinical practice. The vision, therefore, is focused on streamlining processes for trial design and execution, focusing on essential endpoints, decreasing regulatory hurdles, broadening trial access, and increasing the efficiency of data collection.
One specific recommendation involved limiting data elements collected in clinical trials. Limiting clinical trial data collection in late phase trials to essential data elements allows for greater efficiency and lower cost. Low-value data categories were identified: low-grade adverse events and attribution start/stop times, laboratory data that is beyond the standard of care or unrelated to study endpoints or safety monitoring, unused components of panels including unnecessary repetition of full panels, imaging that is beyond the standard of care, concomitant medications that are not relevant to the protocol, start dates for concomitant medications not linked to protocol eligibility or safety, start dates for histories not linked to protocol eligibility or safety, and patient position and resting status for vital signs. Eliminating these data collection elements is expected to reduce operational burden and provide important insights that will inform development of data collection standards for other types of trials.
A second recommendation concerned using electronic health records (EHRs) to support clinical trials. The CTAC recommended engaging vendors to create mechanisms for automatically integrating study-specific documents into local implementations of their products. Furthermore, vendors should be challenged to resolve the logistical and data quality challenges of extracting clinical trial data from electronic health records.
Several other recommendations are focused on addressing critical clinical trial workforce issues: streamlining and standardizing trial activation processes, reducing the volume of trials staff are responsible for, increasing flexibility for remote work, improving alignment of institution and cancer center hiring processes related to staff recruitment and retention, and considering a new NCI training grant program supporting the development of careers in clinical trials at NCI-designated Cancer Centers.
The Virtual Clinical Trials Office
Dr. Doroshow’s presentation ended with a discussion of a Virtual Clinical Trials Office (VCTO) pilot study to expand clinical trials to underserved patients. In this study, research nurses, CRAs, and regulatory affairs personnel are organized through the NCI-Frederick National Lab Clinical Research Directorate. Initial services under consideration include the following: eligibility screening and study coordination to promote trial entry of underserved patients; assistance with informed consent, enrollment, protocol queries, and ‘help desk’ functions; data entry/abstraction from EHR; coordination of study visits, procedures, and participant reminders; regulatory support; and adverse event reporting.
If the pilot proves successful, the VCTO could extend the reach of clinical trials to many underserved populations by providing these services directly to physicians’ offices. This type of program, in coordination with other recommendations put forth by the NCI’s 2030 Vision for Clinical Trials, could accomplish a great deal in the simplification, and therefore effectiveness, of clinical trials. In this way, decreases in clinical trial enrollment and staff shortages initiated by the pandemic may be overcome.
Promoting Structural and Institutional Change to Reduce Poverty and Cancer
Dr. Shobha Srinivasan is Senior Advisor for Health Disparities in the Office of the Director, Division of Cancer Control and Population Sciences (DCCPS), at the National Cancer Institute (NCI).
This plenary session occurred at 9:10 am., Thursday, Feb. 22, 2024, at the 4th biennial Advancing the Science of Cancer in Latinos conference.
Poverty in America
Dr. Srinivasan began by discussing poverty and how it connects to health. Despite advances in cancer prevention, diagnosis, treatment, and survival, disparities in cancer outcomes continue to persist with increased mortality among people living in poverty. Disparities are further exacerbated for those living in geographically underserved areas, defined as areas with high and/or persistent poverty.

Information from the US Census Bureau on real median household income by race and Hispanic origin of householder in 2021 shows Asian households to be the highest earners, at $101,400, while Latino households only earn $58,000. Latino individuals also have the second highest rate of medical debt, behind only Black individuals. Again, the Latino poverty rate is slightly less than the Black poverty rate, 17.1% and 19.5% respectively in 2021, while the poverty rate for non-Hispanic White individuals is 8.1%.
When considering the ratio of poverty population to total population, American Indian and Alaska Natives have the worst ratio. This group makes up 1.2% of the total population, but represents 2.6% of the poverty population, a ratio of 2.2. Latino and Black individuals have the second worst ratio, at 1.5, with Latino individuals making up 19.3% of the total population, but 28.4% of the poverty population.
When looking specifically at child poverty, massive gains were made during the pandemic due to the programs and emergency provisions provided. However, much of that gain has been lost with the expiration of these programs. In America, nearly 11 million, or 1 in 7, children are poor.
The housing crisis further contributes to poverty in many ways. Individuals without an address cannot obtain Medicaid, for example. Extremely low-income families across the US need 6.8 million more affordable housing units, and 70% of this group spend more than half of their income on rent. On any given night, over 580,000 people are experiencing homelessness. Only 1 in 4 extremely low income families who need assistance receive it.
Education and poverty are inextricably linked. Those with no high school diploma have a poverty rate of 25.2%, compared with a poverty rate of 4.3% among people with a bachelor’s degree or higher. Incarceration is another factor that is intimately tied to poverty. At the end of 2022, 32% of inmates were Black, a group that makes up 13.6% of the overall population, and 23% of inmates were Latino, a group that makes up 19.1% of the overall population. In contrast, 31% of inmates were White; White individuals make up 58.9% of the overall population.
The Persistent Poverty Initiative
Persistent poverty is defined as an area where 20% or more of the population has been in poverty for the last 30 years. Dr. Srinivasan and colleagues have shown that people living in US counties with persistent poverty are more likely to die from cancer than people living in other counties. This risk is above and beyond the heightened risk seen in areas experiencing current but not persistent poverty.
The Persistent Poverty Initiative (PPI) aims to address structural and institutional factors to alleviate the cumulative effects of poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and partnering with communities to promote the implementation of community-based programs. Awards have been given to five specialized centers who will work with targeted low-income communities in persistent poverty census tracts. Centers will also train a pipeline of early-career investigators to work with underserved communities in conducting multilevel intervention research.
The five specialized centers include the following: the MD Anderson Cancer Center, which is focused on nutritional interventions in elementary schools and physical activity interventions for cancer survivors; the University of Alabama Birmingham, which is focused on individual health-related activities to improve cancer outcomes and diet and exercise interventions for cancer survivors; Stanford University, which is focused on assessing the effect of guaranteed basic income on determinants of cancer outcomes and testing whether the earned income tax credit promotes the uptake of health promoting behaviors; Weill Cornell Medicine, which is focused on school-based cancer education and social justice curriculum and tobacco cessation; and the University of Utah, which is focused on addressing tobacco cessation and addressing obesity prevention and social determinants of health among American Indian rural and frontier communities. These initiatives and others are driving change and promoting health outcomes among populations living in persistent poverty in the US.
By The Numbers
142
Percent
Expected rise in Latino cancer cases in coming years