Clinical research in the community

Abstract

Most patients with high-risk hematologic malignancies are treated in community oncology practices near their residence. This is partly due to patients' ardent desire to be closer to home and trust in local caregivers. Treatments are increasingly complex, even as initial therapy, and more so upon relapse. Improved outcomes in the past decade are largely available through clinical trials primarily offered through academic medical centers. Limited availability of clinical trials at community oncology practices is a major contributor to outcome disparities among minorities, rural, and elderly patients, all of whom are underrepresented in clinical trials. Between 2003 and 2023, the National Cancer Institute (NCI) established programs to address these challenges: the Community Clinical Oncology Program, Minority- Based Community Clinical Oncology Program, NCI Community Cancer Centers Program, and NCI Community Oncology Research Program. However, disparities have persisted, particularly for pharmaceutical-directed clinical research. Lack of representation in clinical research results in data absenteeism, data chauvinism and hallucination, and a delay in treatment availability for high-risk hematologic malignancies in community practice. To address this, the US Congress enacted the Food and Drug Administration Omnibus Act in 2022 to help establish diversity plans that would broaden clinical trial patient enrollment in the United States. We recommend using these initiatives in community oncology practices, including the adoption of the DRIVE strategy in collaboration with pharmaceutical companies, as well as using the NCI-established programs to promote clinical trial availability for patients with high-risk malignancies treated in community oncology practices.

Graphical abstract

Figure 1.

Experience of the National Cancer Institute Community Cancer Centers Program on community-based cancer clinical trials activity. Change in the accrual of underserved patients by (A) number and (B) percentage of total accrual. Reproduced with permission from Hirsch BR, Locke SC, Abernethy AP. Experience of the National Cancer Institute Community Cancer Centers Program on community-based cancer clinical trials activity. J Oncol Pract. 2016;12(4):e350-8.

Figure 2.

Enrollment odds versus non-Hispanic Whites. Reproduced with permission from Hantel et al.

Figure 3.

Model pathway of trial enrollment process. SES, socioeconomic status. Reproduced with permission from Unger JM, Cook E, Tai E, Bleyer A. The role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;35:185-198.

Figure 4.

DRIVE rank score. *Minority groups in the US are self-defined by the participants and are listed as follows: Hispanic White and Hispanic and non-Hispanic African American or Black, Native American, Asian, Pacific Islander, and mixed race. In other countries, minorities should be defined as appropriate, based on societal norms and internationally medically acceptable groups/nationalities. †Studies will be ranked at the next lower rank if all criteria for next higher rank are not reached. Reproduced with permission from Birhiray and Birhiray.

Figure 5.

Lymphoma survival. Five-year relative survival for selected cancers by race and stage at diagnosis, United States, 2012 to 2018. White and Black race categories are exclusive of Hispanic ethnicity. Reproduced with permission from Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48.