- Clinical trials are crucial to the development of new standards of care for all patients with cancer; to date, however, a minority of patients have had the opportunity to participate in these trials.
- Several abstracts presented at the 2022 ASCO Annual Meeting highlight the positive effects of increasing inclusiveness and advancing equity in clinical trials.
- Topics addressed by researchers at the Meeting included the impact of national health care policies, patient identification and eligibility, and consent via telemedicine in the context of clinical trial enrollment.
Cancer clinical trials play a key role in the development and approval of new standards of care, and the results they generate have the potential to increase overall survival and quality of life for patients with cancer. However, to date, a minority of patients with cancer have participated in clinical trials, and disparities in the inclusion of women, older adults, and certain racial and ethnic groups persist.1,2 Increasing inclusiveness in clinical trials is essential to promoting equity and justice in cancer care, and requires multilevel, transdisciplinary, and stakeholder-engaged solutions. Here, we discuss abstracts presented at the 2022 ASCO Annual Meeting that highlight the effects of strategies to increase inclusiveness and advance equity in clinical trials (Table).3-7
Policies That Impact Access to Clinical Trials
Since the implementation of the Affordable Care Act (ACA), Medicaid expansion has led to increases in rates of insured patients, increases in cancer screening, shifts to early-stage diagnosis of cancer, and improved survival among patients with cancer.8-11 Adding to the evidence supporting the benefits of Medicaid expansion in cancer care, multiple abstracts presented at the 2022 ASCO Annual Meeting highlighted the associations of Medicaid expansion with access to cancer clinical trials.
To evaluate the effect of the ACA’s Medicaid expansion, Unger and colleagues examined the proportion of patients between 1992 and 2020 who were insured by Medicaid upon enrollment into a cancer clinical trial.3 Using data from the SWOG Cancer Research Network, the authors analyzed 47,042 patients age < 65, of whom 10% (4,709 patients) had Medicaid coverage. Following the ACA’s implementation, the odds that patients enrolled in Medicaid would participate in cancer clinical trials increased by 20% per year (odds ratio [OR] 1.20, 95% CI [1.11, 1.30]). By 2020, the proportion of Medicaid-enrolled patients participating in a clinical trial (20.8%; 95% CI [17.1, 25.0]) was nearly 3 times higher than the proportion estimated if the ACA’s Medicaid expansion had not occurred (7.4%; 95% CI [4.8, 9.5]). This increase was primarily seen among female patients and patients from states with Medicaid expansion. These findings are important, as they highlight the effect of national policies in improving access to clinical trials for vulnerable populations and in improving the generalizability of trial findings to the whole U.S. population.
In addition to barriers to access, costs associated with clinical trial participation remain a challenge. Although Medicare and commercial insurances provide coverage of routine costs associated with clinical trial participation, prior to the 2020 enactment of the Clinical Treatment Act, only a subset of states covered routine clinical trial costs for Medicaid enrollees, thereby adding financial barriers to trial access among vulnerable populations. Takvorian and colleagues evaluated the effect of state-mandated Medicaid coverage of routine trial costs on the enrollment of Black participants in cancer clinical trials.4 The researchers conducted a retrospective, quasi-experimental study using data from the ECOG-ACRIN Cancer Research Group. Among 24,321 participants enrolled in therapeutic clinical trials of breast, colorectal, lung, or prostate cancer, 7.2% had Medicaid coverage and 10.5% were Black.
Similar to the results shared by Unger and colleagues, Takvorian et al observed steady increases in the proportion of Medicaid-enrolled clinical trial participants, as well as increases in the proportion of Black participants in this cohort. When comparing states with and without Medicaid coverage mandates, no difference was observed in the proportion of trial participants enrolled in Medicaid. Notably, states with mandated Medicaid coverage of routine trial costs showed a 6.4% increase in the proportion of Black clinical trial participants during the first year following the mandate.
Although noteworthy, this increase in enrollment among Black patients was not sustainable and was not observed in subsequent years. Importantly, these findings emphasize that, although targeted policies have the potential to narrow disparities in clinical trial access, policies that improve insurance coverage alone are unlikely to be sufficient; rather, they should be combined with policies that increase federal accountability and expand clinical research infrastructure and capacity-building in health care settings serving vulnerable communities.12
Identification of Potential Clinical Trial Participants
Furthermore, identification and screening of eligible trial participants remain a challenge. Koselke and colleagues introduced a weekly clinical trial recruitment report with a remote oncology clinical pharmacist to identify and screen eligible patients for a prospective observational trial (protocol 2 of MYLUNG study) in 6 community network practices.5,13,14 Practices averaged 25 oncologists per practice (range, 12-42), 43 open clinical trials per practice (range, 13-89), and 189 patients with lung cancer per year starting treatment (range, 86-358). An oncology pharmacist reviewed chemotherapy regimen orders to identify and screen eligible patients and provided patient data to each on-site research team. Over a 6-month period, the oncology pharmacist screened 367 potentially eligible patients and recommended 325 patients for enrollment, of whom 32% (103 patients) were enrolled. The intervention led to an increase in monthly enrollments at all community practice sites; on average, patient enrollment increased from 3.4 patients per month to 6.6 patients per month (P = .008).
This study demonstrates the value of integrating real-time data into weekly screening reports and members of the multidisciplinary team (ie, oncology pharmacists) into clinical trial recruitment. Importantly, the study also demonstrates feasibility of this integration in a community practice setting. However, the limitations of this study evoke questions, as the authors were unable to quantify the independent effects of the weekly report compared with that of the oncology pharmacist, and, despite this intervention, 32% of patients recommended for enrollment (104 patients) were not enrolled because they exceeded the trial eligibility window.
Clinical Trial Eligibility
Unger and colleagues also examined whether patterns of clinical trial exclusion criteria of patients with brain metastases have changed since the publication of the 2017 joint ASCO, Friends of Cancer Research, and U.S. Food and Drug Administration recommendations to broaden clinical trial criteria to increase inclusiveness.6,15 The authors evaluated patterns of trial eligibility criteria in phases 1 to 3, United States–based, interventional clinical trials for patients with advanced breast, colorectal, or lung cancers from January 2013 through October 2021. After the release of the joint recommendations, there was a 92% increase in the odds of trials not excluding patients with brain metastases compared with conditionally excluding these patients (OR 1.92, 95% CI [1.08, 3.45]). The estimated proportion of trials in which patients with brain metastases were not excluded increased from 9.2% to 15.6% in the post-recommendation period (P = .04). However, there was no significant difference in the proportion of trials in which brain metastases were completely excluded (7.5% vs 5.4%; P = .28).
This work from Unger and colleagues provides evidence of the impact and current adoption of recommendations for broadening clinical trial eligibility criteria for patients with brain metastases. It is important to continue to examine the adoption of these recommendations and advocate for decreasing the number of trials that conditionally or completely exclude patients with brain metastases.
Trial Consent Process
The integration of telemedicine into consent processes and remote monitoring in cancer clinical trials shows the potential to decrease costs and increase access to clinical trials among vulnerable populations and rural communities.16,17 Buckley and colleagues surveyed 589 patients who provided consent for a clinical trial via telemedicine.7 After considering visit-related factors such as time, cost, convenience, quality of care, and interaction with the health care team, most patients (51%) preferred that clinical trial consent visits occurred via telemedicine rather than in-person at a clinic (19%; P < .05). For patients who reported feeling stress, use of telemedicine did not contribute additional stress during the clinical trial consent visits but, rather, reduced stress among 17% of respondents. Importantly, most patients reported no difference in comfort in taking agency-supported actions across 6 domains of the consent process (eg, saying a clinical trial was not right for them, requesting more time to make their decision to participate) while using telemedicine. This work highlights positive patient perspectives regarding the use of telemedicine during the clinical trial consent process.
Increasing access to clinical trials, equity in participation, timely accrual, and representation of diverse participants are imperative to increasing the validity of trial findings. As highlighted by the variety of 2022 ASCO Annual Meeting abstracts discussing trial access, multilevel strategies and multidisciplinary approaches are required to advance equity in clinical trials.
Increasing access to clinical trials, equity in participation, timely accrual, and representation of diverse participants are imperative to increasing the validity of trial findings.
Oncology practices should continuously evaluate their clinical research teams and clinical trial procedures to identify areas of improvement within each practice. This process should be informed by the experiences and input of patients, community members, and members of the research and clinical teams and should leverage existing tools like the ASCO-ACCC Equity, Diversity, and Inclusion (EDI) Research Site Self-Assessment. Interventions like routine screening of potential patients for trial eligibility or the integration of electronic clinical trial consent methods are tangible solutions that can help increase the enrollment of diverse participants and can be implemented in a variety of settings guided by quality and system improvement frameworks. Finally, as individuals and members of the oncology community, we have a significant role as advocates for state and national policies that increase health insurance coverage and access to cancer care for all.
- Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720-2726.
- Duma N, Vera Aguilera J, Paludo J, et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J Oncol Pract. 2018;14(1):e1-e10.
- Unger JM, Xiao H, Vaidya R, Hershman DL. The Medicaid expansion of the Affordable Care Act and participation of patients with Medicaid in cancer clinical trials. J Clin Oncol. 2022 40:16_suppl, 6505-6505.
- Takvorian SU, Chatterjee P, Mamtani R, et al. Association between state Medicaid policies and accrual of Black participants to cancer clinical trials. J Clin Oncol. 2022 40:16_suppl, 1501-1501.
- Koselke E, Hough S, Howell J, et al. Impact of oncology clinical pharmacist intervention on clinical trial enrollment in The U.S. Oncology Network’s MYLUNG Consortium. J Clin Oncol. 2022 40:16_suppl, 1503-1503.
- Unger JM, Xiao H, Hershman DL, Vaidya R. Impact of broadening trial eligibility criteria on the inclusion of patients with brain metastases in cancer clinical trials. J Clin Oncol. 2022 40:16_suppl, 1505-1505.
- Buckley MT, O’Shea M, Lipitz-Snyderman A, et al. Electronic research consents for complex early-phase I-II clinical trials integrated with telemedicine visits compared with in-person encounters. J Clin Oncol. 2022 40:16_suppl, 1514-1514.
- Han X, Jemal A, Zheng Z, Sauer AG, Fedewa S, Yabroff KR. Changes in noninsurance and care unaffordability among cancer survivors following the Affordable Care Act. J Natl Cancer Inst. 2020;112(7):688-697.
- Han X, Zhao J, Yabroff KR, Johnson CJ, Jemal A. Association between Medicaid expansion under the Affordable Care Act and survival among newly diagnosed patients with cancer. J Natl Cancer Inst. 2022;114(8):1176-1185.
- Han X, Yabroff KR, Ward E, Brawley OW, Jemal A. Comparison of insurance status and diagnosis stage among patients with newly diagnosed cancer before vs after implementation of the Patient Protection and Affordable Care Act. JAMA Oncol. 2018;4(12):1713-1720.
- Jemal A, Lin CC, Davidoff AJ, Han X. Changes in insurance coverage and stage at diagnosis among nonelderly patients with cancer after the Affordable Care Act. J Clin Oncol. 2017;35(35):3906-3915.
- Bibbins-Domingo K, Helman A, Dzau VJ. The imperative for diversity and inclusion in clinical trials and health research participation. JAMA. 2022;327(23):2283-2284.
- The US Oncology Network. An Inside Look at the MYLUNG Consortium. Accessed July 27, 2022.
- Evangelist M, Jotte R, Spira A, et al. MYLUNG Consortium: Molecularly informed lung cancer treatment in a community cancer network. Pragmatic prospective RWR study. J Thorac Oncol. 2021;16(10):S1170-S1171.
- Kim ES, Bruinooge SS, Roberts S, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol. 2017;35(33):3737-3744.
- Meghiref Y, Parnot C, Duverger C, et al. The use of telemedicine in cancer clinical trials: Connect-patient-to-doctor prospective study. JMIR Cancer. 2022;8(1):e31255.
- Sirintrapun SJ, Lopez AM. Telemedicine in cancer care. Am Soc Clin Oncol Educ Book. 2018;38:540-545.