Increasing Clinical Trial Participation Rates Among Black Patients With Cancer

Executive Summary

The National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), and the Association of Community Cancer Centers (ACCC) recommend clinical trial participation for any patient with cancer in the US.[1,2] Despite this, overall enrollment remains at 3%-8% for oncology trials, and just 4%-6% of participants are Black. [3] To help address the distinctly low clinical trial participation rates among Black patients, ASCO and ACCC recently published a joint research statement on increasing equity, diversity, and inclusion (EDI) in cancer trials. [1] Although increasing EDI has been greeted with enthusiasm, barriers to increasing diversity in clinical trial enrollment remain. Small cancer centers in particular struggle to remove these barriers to effectively increase clinical trial participation rates among Black patients with cancer. [4,5]

This needs assessment identifies key practice/knowledge gaps and educational needs of hospital staff at a community cancer center and describes learning objectives that could be met through appropriate educational activities.

Introduction

Newly developed cancer therapies are contributing to increased overall cancer survival rates, as well as new standards of care. Yet, overall clinical trial participation remains at 4%-6% of cancer patients in the US. [1,6] In addition to the overall low enrollment numbers for clinical trials, participants are often younger, healthier, and less racially/ethnically and geographically diverse than the overall patient population. [1] This underrepresentation of ethnic and racial minority populations threatens the efficiency and generalizability of cancer research. [3]

Barriers to clinical trial participation in underserved communities involve: [1]

1) patients,

2) trials,

3) clinicians, and

4) institutions.

Patient barriers. People from racial and ethnic minority populations face many barriers. Direct medical costs combined with indirect costs, such as travel, childcare, and time away from work, make trial participation difficult or even impossible for some. Black patients may also abstain from enrolling in trials due to distrust of research and/or medical communities. Finally, trial enrollment can also be limited due to language, communication, and health literacy-related barriers. [1,7,8]

Trial barriers. Clinical trial eligibility is often narrow, restricting patient enrollment. For example, a trial may exclude those with pre-existing health conditions or other characteristics that are more commonly found in racial and ethnic minority groups. [1,7]

Clinical barriers. Clinicians play an important role in clinical trial recruitment. However, some have biases that affect clinical trial enrollment. For instance, clinicians may believe that Black patients are unwilling to participate or to comply with trial protocols. They may also cite logistical reasons as to why a Black person cannot participate, such as lack of clinical trial awareness. [1]

Institutional barriers. Access to trials and decisions about types of trials to open affect participation of people from racial and ethnic minority populations. Trial location may be a problem, as trials might not be available in the communities in which racial and ethnic minority populations receive care. The availability and diversity of research and support staff can affect participation if they do not understand the needs of the patients. [1]

Participation rates are generally lower in community cancer centers compared to clinical research centers. [4] Smaller community cancer centers often lack funding for dedicated recruitment and enrollment personnel, having to rely on existing staff to perform such tasks in addition to their day-to-day clinical practice responsibilities. [5] This needs assessment identified knowledge gaps of hospital staff at a community cancer center that can be addressed by educational programs. Filling these knowledge gaps will result in overall higher clinical trial participation rates, particularly among Black patients.

Knowledge Gaps and Educational Needs

Practice gaps and educational needs were identified based on a survey of employees at a cancer center, as well as the evaluation of relevant medical literature.

Table 1. Knowledge gaps aligned with education needs, learning objectives, and learning outcomes.

Knowledge Gap	Education Need	Learning Objective	​Learning Outcomes
​Hospital staff are unaware of ethnic and racial discrepancies in clinical trial participation rates.	Educate hospital staff about the importance of clinical trial participation. Train staff on existing tools and software to find information about individual patients.	​List the reasons why it is important for patients to take part in clinical trials, and why it is important to be aware of clinical trial participation rates. Describe where to find information about patients participating in clinical trials.	Awareness of discrepancies in clinical trial participation rates will reduce implicit bias and increase diversity of enrollees.
​Intake staff are uncertain about roles and responsibilities.	Train staff on hospital policies and standard operating procedures (SOPs).	List intake staff's roles and responsibilities. Describe hospital policies and SOPs on intake staff's roles and responsibilities.	​Empowering intake staff to do their job will result in systematic and rigorous patient screening for clinical trial eligibility.
​There is a disconnected workflow and lack of communication between clinical trial research staff and clinical intake staff.	Educate hospital staff about policies and SOPs to document patient interactions. Educate staff on the importance of proper patient documentation and cross-functional communication.	Document all interactions with patients using existing systems. Apply concepts of transparency and open communication among hospital care team to hospital workflow.	​Improved workflow and communication will reduce redundancies and ultimately increase efficiencies at the hospital.
​Hospital staff are unaware of metrics to track which patients with cancer are asked about trial participation.	Train hospital staff on consistently using tools to create patient metrics. Train staff on where to find metrics.	Document if patient was asked about clinical trial participation. Summarize which patients were screened for trial participation.	​Available and easy-to-access metrics on who was screened for clinical trial participation will make screening more efficient and increase accountability.

Knowledge Gap 1: Hospital staff are not aware of ethnic and racial discrepancies in clinical trial participation rates.

More than half of cancer patients who are invited to enroll in a clinical trial choose to participate, including Black patients. [9] This means that most patients are willing to participate in a clinical trial if one is offered. [3,9] Not knowing about discrepancies in clinical trial participation rates means hospital staff may not be aware of lower clinical trial participation rates among Black patients. Staff may think they are treating all patients equally, unaware of their own unconscious biases and inappropriate communication with Black patients. [10] Since unconscious biases can affect behavior and patient interactions, they can prevent hospital staff from being systematic about screening and enrolling patients in clinical trials. [3,10]

Knowledge Gap 2: Intake staff are uncertain about roles and responsibilities.

Gaps in education, training, and support of hospital staff prevent systematic screening of each patient for clinical trial enrollment. [3] If intake staff are unaware of their roles and responsibilities, they cannot screen patients as systematically and rigorously as is necessary. Inconsistent screening of patients allows for implicit or explicit biases and inappropriate communication with Black patients to arise. [10] Whereas, a systematic approach can address unconscious biases before they even occur. [10]

Knowledge Gap 3: There is a disconnected workflow and lack of communication between clinical trial research staff and clinical intake staff.

Each hospital staff member plays an important role in recruiting patients for clinical trials. [11] Cross-functional communication and the implementation of a clearly defined “system” are important to prevent a disconnected workflow and uncoordinated patient care. [1,2] Since time is a major resource constraint, inefficient processes can contribute to lower clinical trial enrollment. [5,13] Improving cross-functional communication will increase overall efficiency of patient recruitment and break down existing silos between teams.

Knowledge Gap 4: Poor documentation of patients screened for clinical trial participation contributes to inconsistent screening.

More than half of cancer patients who are offered a clinical trial decide to participate in the US. [5,9] A lack of systematic screening contributes to an ad hoc selection of patients screened for trial eligibility. This ultimately results in a bias towards which patients are offered trial participation. [3] Following protocols, such as checklists, workforce trainings, and accrual logs, promotes systematic and rigorous screening of patients with cancer. [3]

Summary

Although guidelines recommend clinical trial participation for any patient with cancer in the US, enrollment rates among Black patients remain unfavorable. [1] Low EDI in clinical trial participation rates mean that trial results are not necessarily generalizable. [5] Small cancer centers in particular struggle to remove barriers to effectively increase clinical trial participation rates among Black patients. [5,7] This needs assessment focuses on increasing clinical trial participation by training and educating hospital staff on statements, policies, and standard operating procedures.

Filling the knowledge gaps identified in this needs assessment will encourage more rigorous and systematic screening of all patients for clinical trial participation, improve communication and workflows among hospital staff, and ultimately increase overall trial participation rates - particularly among Black patients.

References

1. Oyer RA, Hurley P, Boehmer L, et al. Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement. Journal of Clinical Oncology. 2022;111(3). doi:10.1200/JCO.22.00754

2. Dans M, Kutner JS, Agarwal R, et al. NCCN Guidelines Version 1.2022 Palliative Care Continue NCCN Guidelines Panel Disclosures.

3. Guerra CE, Fleury ME, Byatt LP, Lian T, Pierce L. Strategies to Advance Equity in Cancer Clinical Trials. American Society of Clinical Oncology Educational Book. 2022;(42):127-137. doi:10.1200/edbk_350565

4. Unger JM, Vaidya R, Hershman DL, Minasian LM, Fleury ME. Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst. 2019;111(3):245-255. doi:10.1093/jnci/djy221

5. Allen J, Bergman K, Bruinooge S, et al. A Landscape Report Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer-A Landscape Report Project Steering Committee Members.

6. Loree JM, Anand S, Dasari A, et al. Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals from 2008 to 2018. JAMA Oncol. 2019;5(10). doi:10.1001/jamaoncol.2019.1870

7. Unger JM, Cook E, Tai E, Bleyer A. The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. American Society of Clinical Oncology Educational Book. 2016;36:185-198. doi:10.14694/edbk_156686

8. Gilligan T, Coyle N, Frankel RM, et al. JOURNAL OF CLINICAL ONCOLOGY Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline. J Clin Oncol. 2017;35:3618-3632. doi:10.1200/JCO

9. Unger JM, Hershman DL, Till C, et al. “When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. J Natl Cancer Inst. 2021;113(3):244-257. doi:10.1093/jnci/djaa155

10. Marcelin JR, Siraj DS, Victor R, Kotadia S, Maldonado YA. The Impact of Unconscious Bias in Healthcare: How to Recognize and Mitigate It. Journal of Infectious Diseases. 2019;220:S62-S73. doi:10.1093/infdis/jiz214

11. Clark LT, Watkins L, Piña IL, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019;44(5):148-172. doi:10.1016/j.cpcardiol.2018.11.002

12. Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018;11:156-164. doi:10.1016/j.conctc.2018.08.001

13. Wong AR, Sun V, George K, et al. Barriers to Participation in Therapeutic Clinical Trials as Perceived by Community Oncologists.; 2022. https://doi.org/10.