Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers

Abstract Introduction Equitable and diverse clinical trials participation is essential for practice-changing results to be applicable to all patients. However, patients who identify as minorities, who live in rural areas, and who have low income are typically underrepresented in clinical trials. Increasing clinical trial participation in general and among underrepresented patients in particular is a goal of The Leukemia & Lymphoma Society's (LLS) Clinical Trial Support Center (CTSC), a clinical trial nurse navigation service for patients with blood cancers and their oncologists. The Veterans Health Administration (VA) is a national network of health care facilities. Approximately 3% of cancers in the United States are diagnosed in the VA. The prevalence of certain blood cancers is higher in the VA, in part due to military exposures. Veterans who receive care in the VA are more likely to have lower income, live in rural areas, and have comorbidities than patients who receive care in the private sector. Clinical trial participation among Veterans may be hampered by VA-specific factors (e.g. relatively fewer clinical trial options in the VA, lack of awareness that Veterans may be referred to participate in clinical trials outside of the VA) and patient-specific factors (e.g. income, rurality, comorbidities, and minority status). This study aimed to characterize and overcome barriers to Veteran enrollment in blood cancer clinical trials. Methods The LLS CTSC performs clinical trial searches using a database with information from clinicaltrials.gov and other proprietary data. To assess the impact of geography and rurality on the availability of clinical trials, we performed simulated searches for clinical trials in proximity of 13 VA facilities (6 rural, 7 urban), six blood cancers (AML, CLL, DLBCL, FL, MDS, MM), and two disease statuses (new diagnosis, relapsed/refractory). To further evaluate barriers to CTSC referral and clinical trial enrollment among Veterans who receive care in the VA, we collected data about referral patterns of VA hematologist-oncologists and Veterans' treatment choices at four VA facilities between September 2020 through May 2021. Results When evaluating both 100- and 200-mile radii from the VA facilities in simulated searches, there were significantly more clinical trials available for Veterans who receive care in urban compared to rural areas and on the East or West Coast compared to the Midwest, in aggregate (all cancers) and by disease type or status (p unadj < 0.0001). Forty-eight Veterans with blood cancers at the Durham NC, Salem VA, Sioux Falls SD, and Clarksburg WV VA facilities had consideration of clinical trials as a treatment option by oncology providers over a nine-month period. All Veterans were male, with 33 White/15 African-American, 47 non-Hispanic/1 Hispanic, age 41-93 years (median 71), living 0.2-186 miles from their VA facility (median 33.1), with diverse diseases and stages represented. Of the 48 patients, 14 patients were not asked if they wanted clinical trials information; reasons were need for immediate therapy, co-morbidities, or patient circumstances. Of 34 patients who were asked if they wanted clinical trials information, 14 did not agree to a referral to the CTSC; reasons were preference for immediate therapy, wanting care in the VA, wanting standard therapy, and lack of transportation. Of 20 referred Veterans, two enrolled in clinical trials outside the VA (for CLL and PMF), with investigational therapy provided by the study sponsors. Conclusions Using data from simulated and actual patient referrals to the LLS CTSC, we identified patient, provider, and location specific barriers for Veteran referral and enrollment in blood cancer clinical trials. When offered information about clinical trials, the majority of patients agreed to an LLS CTSC referral, suggesting that patients are generally willing to receive education and information about trial participation if given the opportunity. The LLS CTSC nurse navigators can overcome barriers to enrollment by providing education and identifying potential clinical trials within a desired geographic area. In addition to resources provided by the LLS CTSC, opening additional clinical trials in rural areas and within the VA system could help increase Veteran participation in clinical trials for blood cancers. Disclosures Rodgers: MJH Lifesciences: Consultancy. Weiss: AbbVie Inc.: Research Funding; Amgen Inc.: Research Funding; AstraZeneca Pharmaceuticals: Research Funding; Bristol Myers Squibb: Research Funding.

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Barriers to Recruitment of Rural Patients in Cancer Clinical Trials

Journal of Oncology Practice ◽

10.1200/jop.2010.000158 ◽

2011 ◽

Vol 7 (3) ◽

pp. 172-177 ◽

Cited By ~ 31

Author(s):

Shamsuddin Virani ◽

Lola Burke ◽

Scot C. Remick ◽

Jame Abraham

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Rural Areas ◽

Trial Participation ◽

Cancer Clinical Trials ◽

Clinical Trial Participation ◽

Rural Patients ◽

Patient Concerns

Rates of clinical trial participation are lower among patients in rural areas. Oncologists should be trained to address patient concerns regarding clinical trial availability, utility, and accessibility.

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Disparities in clinical trials participation in a vertically integrated care delivery system.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.128 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 128-128

Author(s):

Ahmed Megahed ◽

Gary L Buchschacher ◽

Ngoc J. Ho ◽

Reina Haque ◽

Robert Michael Cooper

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Healthcare System ◽

Care Delivery ◽

Trial Participation ◽

Cancer Type ◽

Clinical Trial Participation ◽

Integrated Healthcare ◽

Clinical Trial Enrollment ◽

Asian Pacific

128 Background: Sparse data exists on the diversity clinical trial enrollment in community settings. This information is important to ensure equity of care and generalizability of results. Methods: We conducted a retrospective cohort study of members of an integrated healthcare system diagnosed with invasive malignancies (excluding non-melanoma skin cancers) between 2013-2017 to examine demographics of the oncology population compared to those who enrolled in a clinical trial. Logistic regression was used to assess correlates of clinical trial participation, comparing general and screened samples to enrolled sample. Odds ratios were adjusted for gender, geocoded median household income, cancer type, and stage. Results: Of the 84,977 patients with a cancer diagnosis, N = 2606 were screened for clinical trial participation and consented, and of those N = 1372 enrolled. The percent of Latinx (25.8% vs 24.0%; OR 0.9? CI 0.72-1.05) and African American/Black (10.9% vs 11.1%; OR 0.92 CI 0.75-1.11) clinical trial participation mirrored that of the general oncology population, respectively using Non-Hispanic Whites as reference. Asian/Pacific Islander had equal odds of clinical trial enrollment (OR 1.08 CI 0.92-1.27). The enrolled population was younger than the general oncology population. Conclusions: This study suggests that in an integrated healthcare system with equal access to care, the clinical trials population is well representative of its general oncology population.[Table: see text]

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Determinants of Clinical Trial Participation and Impact on Survival Outcomes Among Patients with Newly Diagnosed Multiple Myeloma

Blood ◽

10.1182/blood-2019-131776 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5833-5833

Author(s):

Gabriella C Malave ◽

Prashant Kapoor ◽

Angela Dispenzieri ◽

Morie A. Gertz ◽

Martha Q. Lacy ◽

...

Keyword(s):

Clinical Trial ◽

Overall Survival ◽

Clinical Trials ◽

Board Of Directors ◽

Research Funding ◽

Trial Participation ◽

Newly Diagnosed ◽

Clinical Trial Participation ◽

Advisory Committees ◽

Baseline Characteristics

Background: The overall participation of cancer patients in interventional clinical trials in the United States remains very low, with ~5% of patients being enrolled in clinical trials nationwide. The outcomes of patients with MM have improved significantly over the past decade, but available data suggest that the participation rates for patients with MM is comparable to other cancers. The drivers of participation and the potential impact of clinical trial participation have not been systematically studied in MM. Patients and Methods: We identified 228 patients who were enrolled into clinical trials for initial therapy of newly diagnosed MM between 2004 and 2018, and 4 controls for each of these patients. Controls were patients with NDMM, who were diagnosed closest in time to the index patients and did not participate in an interventional treatment trial. Various baseline characteristics as well as overall survival were compared between the two groups. Results: The baseline characteristics of the two groups are as shown in the Table. Patients who entered clinical trials were more likely to be female, resided closer to the clinic, and were more likely to have a prior history of MGUS. They were more likely to have higher ISS Stage, and a higher serum LDH, but there was no difference in the FISH risk status. Other indices of disease burden such as lower hemoglobin and platelets, higher serum creatinine were all seen more often in the control group, but may have been influenced by the trial entry criteria. Looking at the outcomes, the overall survival was longer among those enrolled into clinical trials compared to those who did not [median 103 (95% CI; 86, 136) vs. 63 (95% CI; 53, 69) months, p<0.001 (Figure). Conclusions: The current study provides important clues regarding demographic determinants of trial participation and disease biology related features that reflect likelihood of trial participation. Overall survival was significantly longer among the trial participants, which likely represent a mix of reasons including baseline status of patients, intensity of monitoring and efficacy of novel treatment approaches. Table Disclosures Kapoor: Janssen: Research Funding; Celgene: Honoraria; Cellectar: Consultancy; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Glaxo Smith Kline: Research Funding; Takeda: Honoraria, Research Funding. Dispenzieri:Alnylam: Research Funding; Janssen: Consultancy; Pfizer: Research Funding; Takeda: Research Funding; Celgene: Research Funding; Akcea: Consultancy; Intellia: Consultancy. Gertz:Ionis: Honoraria; Alnylam: Honoraria; Prothena: Honoraria; Celgene: Honoraria; Janssen: Honoraria; Spectrum: Honoraria, Research Funding. Lacy:Celgene: Research Funding. Dingli:Karyopharm: Research Funding; Rigel: Consultancy; alexion: Consultancy; Janssen: Consultancy; Millenium: Consultancy. Leung:Omeros: Research Funding; Aduro: Membership on an entity's Board of Directors or advisory committees; Takeda: Research Funding; Prothena: Membership on an entity's Board of Directors or advisory committees. Russell:Imanis: Equity Ownership. Kumar:Takeda: Research Funding; Janssen: Consultancy, Research Funding; Celgene: Consultancy, Research Funding.

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Effect on clinical trial participation by integration of a clinical pathway program into an electronic health record (EHR).

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.7_suppl.167 ◽

2016 ◽

Vol 34 (7_suppl) ◽

pp. 167-167 ◽

Cited By ~ 2

Author(s):

Corey J. Shamah ◽

Thomas James Saphner

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Pathway ◽

Capture Rate ◽

Treatment Algorithm ◽

Trial Participation ◽

Clinical Trial Participation ◽

Patient Identification ◽

Decision Algorithm ◽

Clinical Trial Enrollment

167 Background: Patient enrollment to clinical trials is lower than desired. Even large organizations with extensive research support services have many barriers to recruitment and poor rates of enrollment. Barriers to clinical trial participation can be physician related, system related, or patient related. Physician related issues are the largest barrier to patient accrual. Physicians are often not aware that a trial may be available for a patient. While all initial patients are manually screened in our system, screening for subsequent lines of therapy are not. Provider awareness and appropriate patient identification are areas of potential improvement in a large, multisite, hospital affiliated, community oncology setting. Methods: Our oncology group recently implemented Via Oncology (Via), an EHR-integrated clinical pathway decision support tool. Information about the patient, their disease, and goals of care generate a recommended treatment algorithm. The pathways are expected to speed the integration of new treatments into practice and improve accrual to clinical trials. Use of Via is required for all new therapy changes. Within the decision algorithm, an appropriate available clinical trial is suggested as the first option when available. Clinical trial enrollment statistics are being tracked to determine if this method of potential patient identification results in increased enrollments. Results: After 11 months of Via implementation and 103,515 visits, the visit capture rate was 82.7% suggesting that providers adapted to the pathways quickly. With 3,844 decisions made, 83.9% of all treatment decisions were on pathway. Clinical trial enrollment was 122 patients in the 459 days prior to Via implementation, and 102 patients in the 271 days afterwards. This increase in accrual rate was significant (p = 0.00174.) Conclusions: Early results suggest that Via implementation has resulted in a significant increase in clinical trial accrual. The system will eventually be able to track how often a trial is offered and how often it is accepted. We are hopeful that with complete visit capture of all patients, there will be continued improvement in our rate of clinical trial enrollment.

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A step towards equitable clinical trial recruitment: a protocol for the development and preliminary testing of an online prostate cancer health information and clinical trial matching tool

Pilot and Feasibility Studies ◽

10.1186/s40814-019-0516-4 ◽

2019 ◽

Vol 5 (1) ◽

Cited By ~ 1

Author(s):

Hala T. Borno ◽

Brian M. Bakke ◽

Celia Kaplan ◽

Anke Hebig-Prophet ◽

Jessica Chao ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

San Francisco ◽

Medical Information ◽

Human Subjects ◽

Trial Participation ◽

Recruitment Strategies ◽

Cancer Clinical Trials ◽

Clinical Trial Participation ◽

The Usa

Abstract Background Recruitment of a diverse participant pool to cancer clinical trials is an essential component of clinical research as it improves the generalizability of findings. Investigating and piloting novel recruitment strategies that take advantage of ubiquitous digital technologies has become an important component of facilitating broad recruitment and addressing inequities in clinical trial participation. Equitable and inclusive recruitment improves generalizability of clinical trial outcomes, benefiting patients, clinicians, and the research community. The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials. This study aims to measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an Internet-based cancer clinical trial matching tool. This study will also examine the extent to which the Trial Library website, designed to address the linguistic and literacy needs of broader patient populations, influences patient-initiated conversations with physicians about clinical trial participation. Methods This is a study protocol for a non-randomized, single-arm pilot study. This is a mixed methods study design that utilizes the statistical analysis of quantitative survey data and the qualitative analysis of interview data to assess the participant experience with the Trial Library intervention. This study will examine (1) acceptability as a measure of participant satisfaction with this intervention, (2) preliminary measure of efficacy as a measure of proportion of participants with documented clinical trial discussion in the electronic medical record, and (3) feasibility of the intervention as a measure of duration of clinical visit. Discussion The principles that informed the design of the Trial Library intervention aim to be generalizable to clinical trials across many disease contexts. From the ground up, this intervention is built to be inclusive of the linguistic, literacy, and technological needs of underrepresented patient populations. This study will collect essential preliminary data prior to a multi-site randomized clinical trial of the Trial Library intervention. Trial registration This study has received institutional approval from the Committee of Human Subjects Research at the University of California, San Francisco.

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Overcoming Barriers to Clinical Trial Enrollment

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_243729 ◽

2019 ◽

pp. 105-114 ◽

Cited By ~ 11

Author(s):

Ryan D. Nipp ◽

Kessely Hong ◽

Electra D. Paskett

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Treatment Strategies ◽

Trial Participation ◽

Routine Practice ◽

Clinical Trial Participation ◽

Eligibility Criteria ◽

Financial Barriers ◽

Patients With Cancer ◽

Clinical Trial Enrollment

Clinical trials are imperative for testing novel cancer therapies, advancing the science of cancer care, and determining the best treatment strategies to enhance outcomes for patients with cancer. However, barriers to clinical trial enrollment contribute to low participation in cancer clinical trials. Many factors play a role in the persistently low rates of trial participation, including financial barriers, logistical concerns, and the lack of resources for patients and clinicians to support clinical trial enrollment and retention. Furthermore, restrictive eligibility criteria often result in the exclusion of certain patient populations, which thus adds to the widening disparities seen between patients who enroll in trials and those treated in routine practice. Moreover, additional factors, such as difficulty by patients and clinicians in coping with the uncertainty inherent to clinical trial participation, contribute to low trial enrollment and represent key components of the decision-making process. Specifically, patients and clinicians may struggle to assess the risk-benefit ratio and may incorrectly estimate the probability and severity of challenges associated with clinical trial participation, thus complicating the informed consent process. Importantly, research has increasingly focused on overcoming barriers to clinical trial enrollment. A promising solution involves the use of patient navigators to help enhance clinical trial recruitment, enrollment, and retention. Although clinical trials are essential for improving and prolonging the lives of patients with cancer, barriers exist that can impede trial enrollment; yet, efforts to recognize and address these barriers and enhance trial enrollment are being investigated.

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Abstract 16910: High-Frequency In-Person Visits During Clinical Trial Enrollment is Associated With Relative Reduction in Event Rates in Heart Failure Patients Followed Longitudinally

Circulation ◽

10.1161/circ.142.suppl_3.16910 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Liana C Brooks ◽

Rohan R Bhat ◽

Robyn F Farrell ◽

Mark W Schoenike ◽

John A Sbarbaro ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

High Frequency ◽

Trial Participation ◽

Trial Period ◽

Single Center ◽

Hospitalization Rates ◽

Visit Frequency ◽

Clinical Trial Enrollment ◽

Event Rates

Introduction: The COVID-19 Pandemic has mandated limiting routine visit frequency for patients with chronic cardiovascular (CV) diseases. In patients with heart failure (HF) followed longitudinally, the period of clinical trial participation provides an opportunity to evaluate the influence of high-frequency per-protocol in-person visits compared to less frequent routine visits during longitudinal clinical care. Hypothesis: Patients enrolled in clinical trials will have a lower CV and HF event rates during periods of trial enrollment than during non-trial periods. Methods: We examined clinical characteristics, CV and HF hospitalization rates, and outcomes in patients with HF receiving longitudinal HF care at a single center. We evaluated hospitalization rates during the 1-year preceding trial enrollment and hospitalization and death rates during enrollment in clinical trials and for up to 1 year following trial completion. Results: Among the 121 patients enrolled in HF clinical trials, 72% were HFrEF (age 62±11, 19% females, BMI 30.4±6.0, LVEF 25±7, NYHA 2.7±0.6, NT-proBNP 2336±2671) and 28% were HFpEF (age 69±9, BMI 32.1±5.5, 29% females, LVEF 60±10, NYHA 2.4±0.5, NT-proBNP 957±997). Average clinical trial exposure was 8±6.6 months. Per-protocol visit frequency was 16±7 per year during clinical trial enrollment. In the one-year pre-trial period, compared to the within-trial period, CV hospitalizations were 0.88/patient-year vs. 0.32/patient-year (p<0.001) and HF hospitalizations were 0.63/patient-year and 0.24/patient-year (p<0.001), with a mortality rate of 0.04/patient-year during trial participation. In the period of up-to 1 year following the end of trial enrollment CV and HF hospitalizations were intermediate at 0.51/patient-year and 0.27/patient-year with an annualized incremental mortality rate of 0.03/patient-year. Conclusion: In HF patients followed longitudinally at a single center, periods of clinical trial enrollment were associated with high visit frequency and lower CV and HF hospitalization rates. These findings highlight the potential benefits of trial enrollment and high-frequency visits for HF patients at a time when routine visit frequency is being carefully considered during the COVID-19 Pandemic.

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Parental perspectives long term after neonatal clinical trial participation: a survey

Trials ◽

10.1186/s13063-020-04787-0 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Thomas Salaets ◽

Emilie Lavrysen ◽

Anne Smits ◽

Sophie Vanhaesebrouck ◽

Maissa Rayyan ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Trial Participation ◽

Drug Trials ◽

Clinical Trial Participation ◽

Parental Perspectives ◽

Positive Experiences ◽

Almost All

Abstract Background Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Methods Parents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales. Results Complete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware). Conclusions Overall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.

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Patient Income Level and Cancer Clinical Trial Participation

Journal of Clinical Oncology ◽

10.1200/jco.2012.45.4553 ◽

2013 ◽

Vol 31 (5) ◽

pp. 536-542 ◽

Cited By ~ 114

Author(s):

Joseph M. Unger ◽

Dawn L. Hershman ◽

Kathy S. Albain ◽

Carol M. Moinpour ◽

Judith A. Petersen ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Universal Access ◽

Participation Rate ◽

Treatment Decision ◽

Trial Participation ◽

Lower Income ◽

Clinical Trial Participation ◽

Clinical Trial Results ◽

The Impact

Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.

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Barriers to clinical trial accrual: Clinical trialists' perspectives.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e18156 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e18156-e18156

Author(s):

Edward S. Kim ◽

Dax Kurbegov ◽

Patricia A. Hurley ◽

David Michael Waterhouse

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cost Benefit ◽

Trial Participation ◽

Clinical Trial Participation ◽

Eligibility Criteria ◽

Contract Research Organization ◽

The Public ◽

Community Forum ◽

Clinical Trial Accrual

e18156 Background: Oncology clinical trial participation rates remain at historic lows. There are many barriers that impede participation. Understanding those barriers, from the perspective of cancer clinical trialists, will help develop solutions to increase physician and site engagement, with the goal of improving accrual rates and advancing cancer treatment. Methods: Physician investigators and research staff from community-based and academic-based research sites were surveyed during ASCO’s Research Community Forum (RCF) Annual Meeting (N = 159) and through a pre-meeting survey (N = 124) in 2018. Findings and potential solutions were discussed during the meeting. Results: 84% of respondents (n = 84) reported that it took 6-8 months to open a trial and 86% (n = 81) reported that trials had unnecessary delays 70% of the time. The top 10 barriers to accrual identified were: insufficient staffing resources, restrictive eligibility criteria, physician buy-in, site access to trials, burdensome regulatory requirements, difficulty identifying patients, lack of suitable trials, sponsor and contract research organization requirements, patient barriers, and site cost-benefit. Respondents shared strategies to address these barriers. Conclusions: The current state of conducting clinical trials is not sustainable and hinders clinical trial participation. New strategies are needed to ensure patients and practices have access to trials, standardize and streamline processes, reduce inefficiencies, simplify trial activation, reduce regulatory burden, provide sufficient compensation to sites, engage the community and patients, educate the public, and increase collaborations. The ASCO RCF offers resources, available to the public, that offer practical strategies to overcome barriers to clinical trial accrual and has ongoing efforts to facilitate oncology practice participation in clinical trials.

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