Perceived Institutional Barriers Among Clinical and Research Professionals: Minority Participation in Oncology Clinical Trials

PURPOSE: In general, participation rates in cancer clinical trials are very low. However, participation rates are especially low among the socially disadvantaged and racial and ethnic minority groups. These groups have been historically under-represented in cancer clinical trials. Although many patient-related barriers have been studied, institutional factors that are essential for building clinical research infrastructure around the clinical trial enterprise in academic medical centers have been underexplored. MATERIALS AND METHODS: We assessed perspectives of cancer center professional stakeholders on the institutional factors that can potentially influence racial and ethnic minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five US cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Qualitative analyses examined response data focused on institutional factors related to minority recruitment for cancer clinical trials. RESULTS: Four prominent themes emerged regarding institutional barriers among clinical and research professionals. (1) There are no existing programs currently being used to recruit or retain minorities to clinical trials. (2) Institutional efforts are needed to increase trial participation and are not specific to potential minority participants. (3) Access to cancer clinical trials and navigation within an Academic Medical Center need to be simplified to better facilitate recruitment of minority patients. (4) Community outreach by cancer centers will increase clinical research awareness in the community. CONCLUSION: Our research highlights the need to address institutional barriers to improve the success of minority recruitment. To increase participation among minority populations, medical centers must address mutable institutional barriers such as setting specific minority recruitment goals for cancer clinical trials, ensuring that cancer clinical trials are accessible, especially to minority patients, and supporting sustained community outreach programs to increase clinical research awareness.

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The role of clinical research nurses in minority recruitment to cancer clinical trials

Contemporary Clinical Trials ◽

10.1016/j.cct.2021.106590 ◽

2021 ◽

pp. 106590

Author(s):

Kristen A. Legor ◽

Laura L. Hayman ◽

Janice B. Foust ◽

Meghan L. Blazey

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Cancer Clinical Trials ◽

Minority Recruitment ◽

Research Nurses

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Accrual of Black participants to cancer clinical trials following a five-year prospective initiative of community outreach and engagement.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.100 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 100-100

Author(s):

Carmen E. Guerra ◽

Vicki Sallee ◽

Wei-Ting Hwang ◽

Brenda Bryant ◽

Armenta L. Washington ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Catchment Area ◽

Community Outreach ◽

Fold Increase ◽

Cancer Center ◽

Black Communities ◽

Cancer Clinical Trials ◽

Black Patients ◽

Clinical Trial Accrual

100 Background: Accrual of Black participants to cancer clinical trials remains a major challenge across the country. Here, we report the outcomes of a five-year initiative of community outreach and engagement to improve enrollment of adult Black participants to clinical trials at the Abramson Cancer Center (ACC) at the University of Pennsylvania. Methods: Primary metrics were the percentage of Black patients among all cancer cases in our catchment area, the percentage of adult Black patients cared for at the ACC, and the percentage of adult Black participants enrolled on the three types of NCI-defined clinical trials. Results: In 2014, at baseline, Black residents comprised 19% of the population and 16.5% of cancer cases in our catchment area surrounding Philadelphia, but only 11.1% of ACC patients were Black. The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 12.2%, 8.3%, and 13.0%, respectively. We then established a center-wide program with community guidance to address these gaps. Key elements of the program included: 1) culturally tailored marketing strategies for cancer clinical trials; 2) plans for each protocol to facilitate Black participant enrollment; 3) new partnerships with faith-based organizations serving Black communities to conduct educational events about clinical trials; 4) pilot programs with Lyft and Ride Health to address transportation barriers; 5) patient education by nurse navigators regarding cancer and clinical trials; and 6) an improved informed consent process. These efforts reached more than 10,000 individuals in venues including churches, neighborhoods, community parks and centers, and health centers with formats ranging from educational forums to wellness fairs. Reassessing metrics in 2018, we found that the percentage of Black patients seen at ACC had increased to 16.2%, matching the percentage of Black cancer patients among all cancer cases in our catchment area (16.5%). Total cancer clinical trial accrual had increased from 9,308 participants in 2014 to 13,170 in 2018 (41.5% increase). The percentages of Black participants accrued onto treatment, non-therapeutic interventional, and non-interventional trials were 23.9%, 33.1%, and 22.5%, respectively – a 1.7- to 4.0-fold increase in five years and higher than the percentage of Black patients seen at the ACC. Conclusions: Our multifaceted, community-based engagement initiative to encourage clinical trial enrollment was associated with improved accrual of Black participants to cancer clinical trials. These findings also suggest that gaps in access to cancer centers are a key factor driving access to clinical trials. Medicaid expansion occurred concurrently in all states in our catchment area and its impact on accrual merits further research.

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Increasing Clinical Trials Accrual at a Comprehensive Cancer Center

Blood ◽

10.1182/blood.v124.21.1266.1266 ◽

2014 ◽

Vol 124 (21) ◽

pp. 1266-1266

Author(s):

Bayard L. Powell ◽

Debbie Olson ◽

Robert M. Morrell ◽

Terry L. Hales ◽

Kevin P High ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Critical Role ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Point System ◽

Cancer Clinical Trials ◽

Treatment Trials ◽

Academic Year ◽

Year 2013

Abstract Background: During the academic year 2013 (July 2012-June 2013) our accrual to cancer clinical trials, a critical measure of success for a Comprehensive Cancer Center (CCC), was lower than prior years and below the desired level for CCC core grant renewal. Academic physicians were faced with increasing pressures to meet clinical demands, often at the expense of academic productivity, including clinical research. Methods: Our Dean and clinical leadership committed to support our efforts to increase accrual to clinical trials by providing salary support for our Section on Hematology and Oncology for specific milestones of 5%, 10%, and 15% increases in accrual to all clinical trials and in accrual to treatment (NCI definition) trials. The goal of the faculty was to increase accrual by > 15% to all trials and to treatment trials to maximize the “pool”. To determine how to divide the pool among investigators we developed a point system recognizing clinical investigators for roles as a) PI for trials (with additional points for all accrual to their trials) and b) for entering patients on clinical trials. The point system for both roles (PI and entering patients) was weighted relative to the value of the trial to the CCC, e.g. investigator initiated > cooperative group > industry initiated, and treatment trials >> non-treatment trials. In addition, we awarded points for publications (first and senior author > co-author) and presentations (oral > poster; major national meeting > other meetings). Results: During academic year 2014 (July 2013-June 2014) accrual to all cancer clinical trials increased by 140% (276 to 663) and accrual to treatment trials increased 40% (114 to 160). These increases occurred in both hematologic malignancies (95% all; 16% treatment) where we had a strong track record for accruals, and in solid tumors (200% all; 76% treatment) where our prior record was not as strong. Discussion: Accrual to clinical trials, both treatment and non-treatment improved dramatically. Interpretation of cause and effect is complex. The baseline year (2013) included implementation of a new EMR and the recent year (2014) included recruitment of additional faculty. However, 2014 was complicated by implementation of a new practice plan heavily weighted toward individual RVU production, and a decrease in available co-operative group trials to historically low levels. However, we can conclude that attention to this critical role of clinical investigators is important and can influence behavior. We cannot determine whether financial incentives are needed or whether the funding is one of several potential methods of recognition of the importance of clinical trials. It is possible that the commitment to provide financial support for clinical research demonstrated to clinical investigators that the leadership valued clinical trials activity and this recognition was more important than the actual funds. Future efforts will also need to find ways to recognize/reward clinical trials productivity of groups of investigators for their multidisciplinary contributions to the care of patients on clinical trials, without generating internal competition within the groups. Disclosures No relevant conflicts of interest to declare.

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Cancer center clinic and clinical research team perceptions of identity and interactions.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18215 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18215-e18215

Author(s):

David E. Gerber ◽

Torsten Reimer ◽

Sandra Garcia ◽

Mary Gill ◽

Tobi Duncan ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Information Sharing ◽

Care Delivery ◽

Clinical Care ◽

The Other ◽

Cancer Center ◽

Cancer Clinical Trials ◽

Research Staff ◽

Clinic Staff

e18215 Background: As evidenced by the NCI-ASCO Teams in Cancer Care Delivery initiative, there is growing interest in applying an emerging science of teams to oncology clinical care. Treatment of patients on cancer clinical trials requires coordination and cooperation among research and clinic teams. However, little empirical research has examined issues of goal alignment, diffusion of responsibility, and perceived rivalries in this setting. Methods: We developed a survey incorporating modified components of the Adapted Team Climate Inventory, the Measure of Team Identification, and the Measure of In-group Bias. Surveys were administered to research staff and clinic staff. Survey responses were analyzed using t tests and ANOVAs. Results: Responses were received from 104 staff (54 clinic, 50 research). Median duration of professional experience was 8.3 years, and median time in current position was 2.0 years. Research staff identified more strongly with their own group ( P< 0.01) but less strongly with the Cancer Center ( P= 0.02) compared to clinic staff. Both clinic and research staff viewed their own group’s goals as clearer than those of the other group ( P< 0.01). Both clinic staff and research staff felt that members of their groups shared information among themselves more than the other group ( P< 0.01). Research staff felt information sharing occurred to a greater extent in both groups than did clinic staff ( P< 0.01). Similar results were noted regarding information sharing with the other group ( Ps< 0.01). Staff indicated that members of their own groups interacted more often with each other than did members of the other group ( P< 0.01), with research staff perceiving higher interaction rates in both teams than clinic staff ( P< 0.01). Research staff perceived daily outcomes to be more important than did clinic staff ( P =0.05), in particular research-related outcomes ( P =0.07). Conclusions: Clinical research staff and clinic staff identify more strongly with their own groups and feel that their own group’s goals are clearer than those of the other group. Further study of interactions, perceptions, and attitudes between research staff and clinic staff is essential to provision of quality care to patients on cancer clinical trials.

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Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxaa426 ◽

2021 ◽

Author(s):

Nathaniel J Rhodes ◽

Atheer Dairem ◽

William J Moore ◽

Anooj Shah ◽

Michael J Postelnick ◽

...

Keyword(s):

Clinical Trials ◽

Drug Therapy ◽

Supportive Care ◽

The United States ◽

Primary Objective ◽

Point Prevalence ◽

Medical Centers ◽

Academic Medical ◽

History Of ◽

Secondary Objective

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P < 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments.

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Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials

Journal of Oncology Practice ◽

10.1200/jop.0842001 ◽

2008 ◽

Vol 4 (4) ◽

pp. 162-168 ◽

Cited By ~ 45

Author(s):

Michele Basche ◽

Anna E. Barón ◽

S. Gail Eckhardt ◽

Lodovico Balducci ◽

Martha Persky ◽

...

Keyword(s):

Clinical Trials ◽

Early Phase ◽

Age Groups ◽

Experimental Treatment ◽

Cancer Center ◽

Cancer Clinical Trials ◽

Sources Of Information ◽

Barriers To Participation ◽

University Center ◽

Barriers To Enrollment

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate. Participants and Methods: In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks. Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%). Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

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Improving hematology/oncology clinical research recruitment via universal prescreening: The VA Connecticut (VACT) Cancer Center experience.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.79 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 79-79

Author(s):

Jenny Jing Xiang ◽

Alicia Roy ◽

Christine Summers ◽

Monica Delvy ◽

Jessica Lee O'Donovan ◽

...

Keyword(s):

Lung Cancer ◽

Clinical Trials ◽

Clinical Research ◽

Cancer Patients ◽

Cancer Center ◽

Cancer Type ◽

Eligibility Criteria ◽

Research Recruitment ◽

Lung Cancer Patients ◽

Study Enrollment

79 Background: Patient-trial matching is a critical step in clinical research recruitment that requires extensive review of clinical data and trial requirements. Prescreening, defined as identifying potentially eligible patients using select eligibility criteria, may streamline the process and increase study enrollment. We describe the real-world experience of implementing a standardized, universal clinical research prescreening protocol within a VA cancer center and its impact on research enrollment. Methods: An IRB approved prescreening protocol was implemented at the VACT Cancer Center in March 2017. All patients with a suspected or confirmed diagnosis of cancer are identified through tumor boards, oncology consults, and clinic lists. Research coordinators perform chart review and manually enter patient demographics, cancer type and stage, and treatment history into a REDCap (Research Electronic Data Capture) database. All clinical trials and their eligibility criteria are also entered into REDCap and updated regularly. REDCap generates real time lists of potential research studies for each patient based on his/her recorded data. The primary oncologist is alerted to a patient’s potential eligibility prior to upcoming clinic visits and thus can plan to discuss clinical research enrollment as appropriate. Results: From March 2017 to December 2020, a total of 2548 unique patients were prescreened into REDCAP. The mean age was 71.5 years, 97.5% were male, and 15.5% were African American. 32.57 % patients had genitourinary cancer, 17.15% had lung cancer, and 46.15% were undergoing malignancy workup. 1412 patients were potentially eligible after prescreening and 556 patients were ultimately enrolled in studies. The number of patients enrolled on therapeutic clinical trials increased after the implementation of the prescreening protocol (35 in 2017, 64 in 2018, 78 in 2019, and 55 in 2020 despite the COVID19 pandemic). Biorepository study enrollment increased from 8 in 2019 to 15 in 2020. The prescreening protocol also enabled 200 patients to be enrolled onto a lung nodule liquid biopsy study from 2017 to 2019. Our prescreening process captured 98.57% of lung cancer patients entered into the cancer registry during the same time period. Conclusions: Universal prescreening streamlined research recruitment operations and was associated with yearly increases in clinical research enrollment at a VA cancer center. Our protocol identified most new lung cancer patients, suggesting that, at least for this malignancy, potential study patients were not missed. The protocol was integral in our program becoming the top accruing VA site for NCI’s National Clinical Trial Network (NCTN) studies since 2019.

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Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

Clinical and Translational Science ◽

10.1111/j.1752-8062.2011.00387.x ◽

2012 ◽

Vol 5 (3) ◽

pp. 281-284 ◽

Cited By ~ 17

Author(s):

Shawn N. Murphy ◽

Anil Dubey ◽

Peter J. Embi ◽

Paul A. Harris ◽

Brent G. Richter ◽

...

Keyword(s):

Clinical Research ◽

Information Technologies ◽

Academic Medical Centers ◽

Medical Centers ◽

Current State ◽

Academic Medical

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Accelerating the clinical trial start-up process for early-phase cancer studies: A test of process change to support rapid activation in an academic medical center.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e17507 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e17507-e17507 ◽

Cited By ~ 1

Author(s):

Sheilah K Hurley ◽

Therica M Miller ◽

Rebecca Flores Stella ◽

Keren Dunn ◽

Ryan Schroeder ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Medical Center ◽

Academic Medical Center ◽

Cancer Center ◽

Small Series ◽

Academic Medical ◽

One Year ◽

Activation Times ◽

High Level

e17507 Background: Clinical trial sponsors have strong scientific, financial, and regulatory interests in rapidly activating studies at participating sites. Academic medical centers have difficulty activating trials within a few weeks of sponsor agreement because, among other inefficiencies, they engage the necessary committee reviews, regulatory approvals, contracting, and budgeting in serial fashion. Incremental revisions in such workflows do not result in strong improvements. Methods: We redesigned our institutional workflow to complete clinical trial activation tasks within six weeks. Historical procedures were replaced rather than scrutinized. A high level leadership committee was required to change and integrate procedures across the medical center, and engage sponsors to improve their turnaround times. A web-based collaborative workflow tracking tool was created to help coordinate the necessary tasks and measure performance. Six clinical trials from the Cancer Center portfolio were used to test and improve the new workflow. Results: Clinical trial activation redesign took one year. For the six studies used as tests of change, the activation times were 49, 54, 78, 58, 62, and 32 days. Times in excess of 6 weeks were largely due to sponsor delays. Conclusions: Considerable effort is required to significantly alter a complex workflow like clinical trial activation. Appropriate priorities, leadership, staffing, and tools are required. Markedly shortened study activation for a small series of cancer trials taught our academic medical center lessons that will be useful for improving the process for all clinical trials, and will make us a better partner for pharmaceutical and academic sponsors as well as for investigator initiated research. [Table: see text]

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