Participation in and withdrawal from cancer clinical trials: A survey of clinical research coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

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Nurses and Clinical Research Coordinators (CRCs) collaboration to improve quality in clinical trials

Annals of Oncology ◽

10.1093/annonc/mdv345.09 ◽

2015 ◽

Vol 26 ◽

pp. vi108

Author(s):

A. Zeneli ◽

P. Serra ◽

T. Rosanna ◽

B. Marina ◽

D. Andreis ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Improve Quality ◽

Clinical Research Coordinators

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Roll of Clinical Research Coordinators (CRC) in Ensuring that Clinical Trials are Conducted Properly-Study on the CRC Support for Patient Enrollment, Exclusion and Withdrawal-

Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) ◽

10.5649/jjphcs.30.666 ◽

2004 ◽

Vol 30 (10) ◽

pp. 666-671 ◽

Cited By ~ 2

Author(s):

Katsuko Okazawa ◽

Eriko Watanabe ◽

Michiko Tsuchiya ◽

Yuki Kasahara ◽

Mitsuo Takano

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Clinical Research Coordinators ◽

Patient Enrollment

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REACT: A feasibility study to test the integration of a cancer registry early case ascertainment process via electronic pathology reporting with an online clinical trial matching tool.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.207 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 207-207

Author(s):

Hala Borno ◽

Christine Duffy ◽

Sylvia Zhang ◽

Zinnia Loya ◽

Todd Golden ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Feasibility Study ◽

Cancer Registry ◽

Cancer Clinical Trials ◽

Case Ascertainment ◽

Early Case ◽

Diverse Patient Populations

207 Background: Representation of diverse patient populations in prostate cancer clinical trials is essential to ensure results are applicable to all men. However, underrepresentation among underserved populations remains a critical problem. Population-based cancer registries provide a potential platform to overcome problems with inclusion of diverse patient populations in clinical research when used as a source for recruitment. Methods: Leveraging statewide implementation of early-case ascertainment (ECA) via electronic pathology for cancer case identification, we performed a feasibility study within the Greater Bay Area Cancer Registry to (1) test a process using ECA to identify new cases of advanced prostate cancer for potential enrollment into clinical trials and (2) test the utility of an online clinical trial matching tool to improve matching of underrepresented patients into clinical trials. All study materials were translated into Spanish, and recruiters were Spanish-speaking. Results: A total of 419 cases were identified from 19 reporting facilities through ECA and sent invitation letters; 18 cases were excluded due to physician contraindication, and 68 (16%) declined participation. All enrolled participants (N=54) completed baseline surveys. To date, 40 participants completed follow-up surveys after using the online matching tool. Most participants were White (80%), of higher income (>$150,000; 41%), and college-educated (70%). Thirty-seven percent indicated awareness of cancer clinical trials, 69% stated interest in participating in clinical research, and 72% held a positive attitude towards cancer clinical trials. However, 46% indicated they would not participate in a randomized study. To assess utility of the matching tool, 65% indicated it increased their interest in participating in a clinical trial. Conclusions: ECA needs to ensure sociodemographic data are available to make it useful as a tool for clinical trials. Preliminary results indicate ECA used in combination with an online clinical trial matching tool may serve as an important recruitment vehicle for prostate cancer clinical trials.

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

JCO Oncology Practice ◽

10.1200/op.20.00970 ◽

2021 ◽

Vol 17 (5) ◽

pp. e666-e675 ◽

Cited By ~ 1

Author(s):

Soumya J. Niranjan ◽

Jennifer A. Wenzel ◽

Michelle Y. Martin ◽

Mona N. Fouad ◽

Selwyn M. Vickers ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Community Outreach ◽

Institutional Factors ◽

Cancer Center ◽

Cancer Clinical Trials ◽

Minority Recruitment ◽

Institutional Barriers ◽

Medical Centers ◽

Academic Medical

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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Abstract WP333: Clinical Research Coordinators' Barriers and Best Practices to Minority Recruitment in Stroke Clinical Trials

Stroke ◽

10.1161/str.47.suppl_1.wp333 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Jazmin Rivera ◽

Lauren Southwick ◽

Nina S Parikh ◽

Sean Haley ◽

Bernadette Boden-Albala

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Focus Groups ◽

Team Building ◽

Patient Centered ◽

Organizational Barriers ◽

Internet Resources ◽

Clinical Research Coordinators ◽

Recruitment Challenges

Background: Poor recruitment and retention of clinical trial participants continues to be a major contributor to the early termination of many clinical trials. Specifically, low racial-ethnic minority and female participation rates can limit scientific, economic, and ethical value of a clinical trial. Previous literature has explored patient-centered enrollment barriers, while research has yet to investigate recruitment challenges facing clinical research coordinators (CRCs). Aim: To gain insight of the barriers facings CRCs with particular attention to minority and female recruitment efforts. Methods: Two semi-structured focus groups were conducted with a purposive sample of stroke CRCs in 2013 (N=17) and 2014 (N=23). Discussion topics included: 1) integrating NIH Inclusion Policy into trial design and recruitment strategies; 2) experiences recruiting minorities and women in stroke/neurological trials; and 3) strategies to enhance minority and female involvement. Two reviewers independently developed an initial set of base codes (n=6). Reviewers met and reconciled their independent coding using the 2013 transcript before applying the same process to the 2014 transcript. Codes and sub-codes were used to identify thematic areas. Results: Both focus groups included majority female participants with nearly half holding nursing degree. Codes informed three thematic areas: administration, enrollment and “other.” Administrative findings highlight organizational barriers. Enrollment findings identified challenges related to the severity of condition and time limitations. The “other” theme cut across administration and enrollment, often informed by coordinators’ personal experiences. Personal barriers include biases and uncertainty approaching patients from diverse backgrounds. Participants identified coordinator conferences, trainings, Internet resources, direct support from PIs and team building between hospital and research staff as key strategies. Conclusion: Our findings identified multi-dimensional organizational, administrative and resource barriers and the need for more focused CRC support to enhance participant recruitment efforts in stroke clinical 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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The European Organisation for Research and Treatment of Cancer Imaging Programme

European Oncology & Haematology ◽

10.17925/eoh.2010.06.1.92 ◽

2010 ◽

Vol 06 (01) ◽

pp. 92

Author(s):

John Bean ◽

Jocelyne Flament ◽

Pascal Ruyskart ◽

Françoise Meunier ◽

◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Clinical Research ◽

Cancer Treatment ◽

Cancer Imaging ◽

Therapeutic Strategies ◽

Cancer Clinical Trials ◽

Imaging Technologies ◽

European Organisation

The European Organisation for Research and Treatment of Cancer (EORTC), an international organisation under Belgian law, develops, conducts, co-ordinates and stimulates translational and clinical research in Europe aimed at improving the management of cancer and related problems by increasing survival and also improving patient quality of life. Imaging is now playing an increasingly important role in the treatment of cancer, and in order to further its mission to improve the standard of cancer treatment through the testing of more effective therapeutic strategies, the EORTC has initiated a cancer imaging programme. The objectives of this programme are to build an image exchange platform for cancer clinical trials, create an EORTC Imaging Group, network with stakeholders in cancer imaging, stimulate the integration of imaging components into EORTC studies, participate in major EU initiatives and link up with US co-operative groups. The EORTC is dedicated to improving the quality and consistency of evaluation of cancer treatment within its clinical trials through the incorporation of imaging technologies used for treatment definition for radiotherapy, staging, prediction and evaluation of response, or pathology.

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