Removing barriers to clinical research in community hospitals—The Fox Chase Cancer Center Partners experience

6614 Background: Although the majority of cancer patients are treated in community hospitals, resources to support community clinical trials are often limited. The Fox Chase Cancer Center Partners (FCCCP) initiative is a large academic and community based oncology program in the Delaware Valley. We hypothesized that a detailed clinical research assessment within the 18 main community cancer research programs of the FCCCP would result in improved clinical trial accrual. Methods: The FCCCP clinical team completed research assessments at 10 affiliated community hospitals during 2004–2006 to evaluate active trials, research nurses and data managers, and research barriers. Institutions were benchmarked for staffing, processes, outreach, and quality improvement. Results were presented to administration at each hospital and impact on research accrual recorded. Results: In 2004, 371 patients were treated on clinical trials at 18 FCCCP community research programs. The median number of data managers, research nurses, and open protocols per site was 0.7, 1.6 and 48 respectively. The most common perceived barriers to accrual by investigators and research staff were regulatory burden, time, and awareness. Recommendations included: improved tumor registry identification of clinical trial candidates, increased staffing, improved web-based outreach, and targeted research affiliations. With regulatory burden a significant research barrier, the following IRB streamlining processes were recommended: NCI Central IRB, for-profit IRBs, IRB reciprocity, and centralized health system IRBs. With implementation of recommendations, 10/18 IRBs have transferred to the NCI-Central IRB for phase III cooperative group studies. The median number of data managers and research nurses per site increased to 1.25 and 1.7 respectively. Although the median number of open trials per site remained at 48, accruals to clinical trials increased to 805, representing a 116% increase. Conclusions: Research assessments are feasible in a large academic-community hospital partnership program and result in best practice recommendations with increased clinical trial accrual. Larger scale implementation of research infrastructure in community oncology programs is warranted. No significant financial relationships to disclose.

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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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Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers

JCO Oncology Practice ◽

10.1200/op.20.00501 ◽

2020 ◽

pp. OP.20.00501

Author(s):

Carrie Lee ◽

Theresa L. Werner ◽

Allison M. Deal ◽

Cassandra J. Krise-Confair ◽

Tricia Adrales Bentz ◽

...

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

North America ◽

Clinical Research ◽

The United States ◽

Median Number ◽

Steering Committee ◽

Full Time ◽

Cancer Centers

PURPOSE: Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation. The Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) steering committee developed a survey to address this knowledge gap. METHODS: An 11-question survey that addressed CTO budget, accrual and trial volume, full-time equivalents (FTEs), staff turnover, and activation timelines was developed by the AACI CRI steering committee and sent to 92 academic cancer research centers in North America (n = 90 in the United States; n = 2 in Canada), with 79 respondents completing the survey (86% completion rate). RESULTS: The number of FTE employees working in the CTOs ranged from 4.5 to 811 (median, 104). The median number of analytic cases (ie, newly diagnosed or received first course of treatment) reported by the main center was 3,856. Annual CTO budgets ranged from $250,000 to $23,900,000 (median, $8.2 million). The median trial activation time, based on 61 centers, was 167 days. The median number of accruals per center was 480 (range, 5-6,271) and median number of trials per center was 282 (range, 31-1,833). Budget and FTE ranges varied by NCI designation. CONCLUSION: The response rate to the survey was high. These data will allow cancer centers to evaluate their CTO infrastructure, funding, portfolio, and/or accrual goals as compared with peers. A wide range in each of the outcomes was noted, in keeping with the wide variation in size and scope of cancer center CTOs across the United States and Canada. These variations may warrant additional investigation.

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Overcoming clinical trial accrual barriers at UPMC: A successful experience.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e14152 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e14152-e14152

Author(s):

Vincent Edgar Reyes ◽

Terry L. Evans ◽

Robert Alan VanderWeele ◽

Christopher Ritchie Marsh ◽

Sajid M. Peracha ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Medical Oncology ◽

The United States ◽

Cancer Center ◽

Therapeutic Trial ◽

Interventional Trial ◽

Community Oncology ◽

Community Physician ◽

Clinical Trial Accrual

e14152 Background: UPMC Hillman Cancer Center Medical Oncology Network is one of the largest integrated community oncology network in the United States. A large gap exists between trial participation rates and the willingness of patients and physicians. There are numerous barriers to clinical trial accrual in the medical oncology community. UPMC identified and created solutions to overcome barriers, and thus dramatically increase clinical trial accrual in 2019. Methods: A physician led advisory board was created to identity problems and find solutions to increase clinical trial accrual in the community. Processes that were implemented in the community to increase physician engagement included identifying more community friendly clinical trials, highlighting high impact clinical trials, and reprioritizing available clinical trials. Also, community physician champions were selected and directly linked with the academic faculty by disease site at UPMC Hillman Cancer Center. Other marketing tools were utilized like a newly developed mobile clinical trial app, community physician dedicated clinical trial retreat, and clinical trial newsletter. High volume community sites were identified as flagship clinical trial accrual centers. Results: With the implementation of physician led initiatives, total (interventional + non interventional) clinical trial accrual increased in the UPMC medical oncology network from 216 in 2018 to 660 in 2019. In 2019 there were 631 interventional trial accruals and 363 therapeutic trial accruals. In 2018 there were only 186 interventional trial accruals and 46 therapeutic trial accruals. Conclusions: The community oncology-directed initiatives created a culture change among the community physicians. UPMC implemented new processes in the medical oncology network that significantly increased clinical trial accrual. [Table: see text]

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Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.6.1728 ◽

2001 ◽

Vol 19 (6) ◽

pp. 1728-1733 ◽

Cited By ~ 384

Author(s):

Primo N. Lara ◽

Roger Higdon ◽

Nelson Lim ◽

Karen Kwan ◽

Michael Tanaka ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Private Insurance ◽

Cancer Clinical Trial ◽

Cancer Center ◽

Trial Participation ◽

Cancer Clinical Trials ◽

Eligibility Criteria ◽

Clinical Trial Accrual ◽

Patient Accrual

PURPOSE: Well-conducted cancer clinical trials are essential for improving patient outcomes. Unfortunately, only 3% of new cancer patients participate in clinical trials. Barriers to patient accrual in cancer clinical trials must be identified and overcome to increase patient participation. MATERIALS AND METHODS: We prospectively tracked factors that potentially affected patient accrual into cancer clinical trials at the University of California Davis Cancer Center. Oncologists seeing new outpatients were asked to complete questionnaires regarding patient characteristics and the physician’s decision-making on patient eligibility, protocol availability, and patient opinions on participation. Statistical analysis was performed to correlate these parameters with subsequent protocol accrual. RESULTS: There were 276 assessable patients. At the initial visits, physicians did not consider clinical trials in 38% (105/276) of patients principally because of a perception of protocol unavailability and poor performance status. Physicians considered 62% (171/276) of patients for participation in clinical trials. Of these, only 53% (91/171) had an appropriate protocol available for site and stage of disease. Seventy-six of 90 patients (84%) with available protocols met eligibility criteria for a particular study. Only 39 of 76 patients (51%) agreed to participate in cancer clinical trials, for an overall accrual rate of 14% (39/276). The remainder (37/76, 49%) declined trial participation despite meeting eligibility criteria. The most common reasons were a desire for other treatment (34%), distance from the cancer center (13%), patient refusal to disclose reason (11%), and insurance denial (8%). Patients with private insurance were less likely to enroll in clinical trials compared to those with government-funded insurance (OR, 0.34; P = .03; 95% CI, 0.13 to 0.9). CONCLUSION: Barriers to cancer clinical trial accrual can be prospectively identified and addressed in the development and conduct of future studies, which may potentially lead to more robust clinical trials enrollment. Investigation of patient perceptions regarding the clinical trials process and the role of third party–payers is warranted.

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Assessing Clinical Trial–Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool

Journal of Oncology Practice ◽

10.1200/jop.2015.008920 ◽

2016 ◽

Vol 12 (5) ◽

pp. e536-e547 ◽

Cited By ~ 6

Author(s):

Marjorie J. Good ◽

Patricia Hurley ◽

Kaitlin M. Woo ◽

Connie Szczepanek ◽

Teresa Stewart ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Research ◽

Research Program ◽

Assessment Tool ◽

Cancer Control ◽

Community Based ◽

Community Based Research ◽

Research Programs ◽

Number Of Patients ◽

Clinical Trial Accrual

Purpose: Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial–associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Methods: Community-based research programs were recruited to collect and enter clinical trial–associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Results: Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. Conclusion: The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings.

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NCI–Clinical Trial Accrual in a Community Network Affiliated with a Designated Cancer Center

Journal of Clinical Medicine ◽

10.3390/jcm9061970 ◽

2020 ◽

Vol 9 (6) ◽

pp. 1970 ◽

Cited By ~ 1

Author(s):

Daniel J. Kim ◽

Dan Otap ◽

Nora Ruel ◽

Naveen Gupta ◽

Naveed Khan ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Treatment Options ◽

Tertiary Care ◽

Racial Diversity ◽

Cancer Center ◽

Main Campus ◽

Therapeutic Trials ◽

Clinical Trial Accrual ◽

Community Site

Most cancer care is delivered in the community, while most clinical trials exist in academic centers. We analyzed clinical trial accrual of a tertiary care cancer center and its affiliated community sites to better understand what types of trials accrued at the community sites and whether community accrual increased ethnic diversity. The institutional clinical trial database was searched for solid tumor accruals during 2018–2019. Patient’s race was abstracted, and trial’s funding source, phase, and disease type/stage were tabulated. Of 3689 accruals, 133 were at community sites, representing 26 unique trials while the main campus accrued to 93 unique trials. Community site accruals were highest for breast and colorectal cancer, but patients with less common cancers such as renal, nasopharyngeal, and gastric cancer were also accrued at community sites. Accruals occurred to randomized trials, as well as phase Ib and translational biomarker studies. Minority patients constituted 20.0% and 32.5% of community site accruals for therapeutic and non-therapeutic trials respectively, compared to 20.6% and 29.8% of main campus accruals for therapeutic and non-therapeutic trials, respectively. We conclude that community sites affiliated with an academic cancer center can accrue to a broad spectrum of clinical trials while enhancing racial diversity in participation of clinical trials. Further expansion of access to clinical trials in community sites is necessary to broaden patient access to state-of-the-art and next-generation treatment options.

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The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

10.2196/preprints.17630 ◽

2019 ◽

Author(s):

Allison Hirsch ◽

Mahip Grewal ◽

Anthony James Martorell ◽

Brian Michael Iacoviello

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Scoping Review ◽

Digital Technologies ◽

Good Clinical Practice ◽

The United States ◽

Clinical Trial Research ◽

Digital Methods ◽

Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

Applied Clinical Informatics ◽

10.1055/s-0041-1727153 ◽

2021 ◽

Vol 12 (02) ◽

pp. 293-300

Author(s):

Kevin S. Naceanceno ◽

Stacey L. House ◽

Phillip V. Asaro

Keyword(s):

Clinical Trial ◽

Emergency Department ◽

Clinical Trials ◽

Clinical Research ◽

Substantial Reduction ◽

Text Message ◽

High Volume ◽

Text Messages ◽

Shared Task ◽

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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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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