scholarly journals Barriers to accrual and enrollment in brain tumor trials

2019 ◽  
Author(s):  
Eudocia Q Lee ◽  
Ugonma N Chukwueke ◽  
Shawn L Hervey-Jumper ◽  
John F de Groot ◽  
Jose Pablo Leone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Brain Tumor ◽  
Response Assessment ◽  
Adult Brain ◽  
Cooperative Groups ◽  
Tumor Patients ◽  
Cancer Society ◽  
Clinical Trial Accrual ◽  
Patient Advocacy Groups

Abstract Many factors contribute to the poor survival of malignant brain tumor patients, some of which are not easily remedied. However, one contributor to the lack of progress that may be modifiable is poor clinical trial accrual. Surveys of brain tumor patients and neuro-oncology providers suggest that clinicians do a poor job of discussing clinical trials with patients and referring patients for clinical trials. Yet, data from the Cancer Action Network of the American Cancer Society suggest that most eligible oncology patients asked to enroll on a clinical trial will agree to do so. To this end, the Society for Neuro-Oncology (SNO) in collaboration with the Response Assessment in Neuro-Oncology (RANO) Working Group, patient advocacy groups, clinical trial cooperative groups, including the Adult Brain Tumor Consortium (ABTC), and other partners are working together with the intent to double clinical trial accrual over the next 5 years. Here we describe the factors contributing to poor clinical trial accrual in neuro-oncology and offer possible solutions.

scholarly journals Barriers to accrual and enrollment in brain tumor trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2024-2024 ◽  
Author(s):  
Eudocia Quant Lee ◽  
Ugonma Nnenna Chukwueke ◽  
Shawn L. Hervey-Jumper ◽  
John Frederick De Groot ◽  
Jose Pablo Leone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Response Assessment ◽  
Patient Advocacy ◽  
Cooperative Groups ◽  
Advocacy Groups ◽  
Oncology Patient ◽  
Clinical Trial Accrual ◽  
Multi Stakeholder ◽  
Patient Advocacy Groups ◽  
Major Impediment

2024 Background: A major impediment to improving neuro-oncology outcomes is poor clinical trial accrual. Methods: We convened a multi-stakeholder group including Society for Neuro-Oncology, Response Assessment in Neuro-Oncology, patient advocacy groups, clinical trial cooperative groups, and other partners to determine how we can improve trial accrual. Results: We describe selected factors contributing to poor trial accrual and possible solutions. Conclusions: We will implement strategies with the intent to double trial accrual over the next 5 years. [Table: see text]

scholarly journals INNV-33. BARRIERS TO ACCRUAL AND ENROLLMENT IN BRAIN TUMOR TRIALS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi137-vi137
Author(s):  
Eudocia Lee ◽  
Ugonma Chukwueke ◽  
Shawn Hervey-Jumper ◽  
John DeGroot ◽  
Pablo Leone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Organizational Factors ◽  
Response Assessment ◽  
Cooperative Groups ◽  
Advocacy Groups ◽  
Oncology Patient ◽  
Community Factors ◽  
Clinical Trial Accrual ◽  
Multi Stakeholder ◽  
Patient Advocacy Groups

Abstract BACKGROUND A major impediment to improving neuro-oncology outcomes is poor clinical trial accrual. METHODS We convened a multi-stakeholder group including Society for Neuro-Oncology, Response Assessment in Neuro-Oncology, patient advocacy groups, clinical trial cooperative groups, and other partners to determine how we can improve trial accrual. RESULTS We described selected factors contributing to poor trial accrual and possible solutions. We focused on patient and community factors, disparities, physician and provider factors, clinical trial factors, and site and organizational factors CONCLUSIONS We will implement strategies with the intent to double accrual to neuro-oncology trials over the next 5 years.

Rehabilitation pathways in adult brain tumor patients in the first 12 months of disease. A retrospective analysis of services utilization in 719 patients

2016 ◽  
Vol 24 (11) ◽  
pp. 4801-4806 ◽  
Author(s):  
Andrea Pace ◽  
Veronica Villani ◽  
Cristiano Parisi ◽  
Stefano Di Felice ◽  
Margaux Lamaro ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Retrospective Analysis ◽  
Adult Brain ◽  
Tumor Patients ◽  
Services Utilization

The role of experience and clinical decision support in clinical trial accrual within oncology.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1527-1527
Author(s):  
Waqas Haque ◽  
Ann M. Geiger ◽  
Celette Sugg Skinner ◽  
Rasmi Nair ◽  
Simon Craddock Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Decision Support ◽  
Clinical Decision Support ◽  
Clinical Decision ◽  
Principal Investigator ◽  
Physician Practices ◽  
The Past ◽  
The Future ◽  
Clinical Trial Accrual

1527 Background: Patient accrual for cancer clinical trials is suboptimal. The complexity of applying eligibility criteria and enrolling patients may deter oncologists from recommending patients for a trial. As such, there is a need to understand how experience, training, and clinical decision support impact physician practices and intentions related to trial accrual. Methods: From May to September 2017, we conducted a survey on clinical trial accrual in a national sample of medical, surgical, and radiation oncologists. The 20-minute survey assessed barriers and facilitators to clinical trial accrual, including experience (e.g., “In the past 5 years, have you been a study or site PI of a trial?”), training (e.g., “Did you receive training about trial design and recruitment as part of medical school, residency, or fellowship? After fellowship?”), and clinical decision support (e.g., “What kind of clinical decision support has your practice implemented?). We used logistic regression to identify factors associated with frequency of discussing trials (with ≥25% of patients) and likelihood of recommending a trial to a patient (likely or very likely) in the future. Results: Survey respondents (n = 1,030) were mostly medical oncologists (59%), age 35-54 years (67%), male (74%), and not in academic practice (58%). About 18% of respondents (n = 183) reported discussing trials with ≥25% of their patients, and 80% reported being likely or very likely to recommend a trial to a patient in the future. Prior experience as principal investigator of a trial was associated with both frequency of discussing trials (OR 3.27, 95% CI 2.25, 4.75) and likelihood of recommending a trial in the future (OR 5.22, 95% CI 3.71, 7.34), as was receiving additional training in clinical trials after fellowship (discussion with patients: OR 2.48, 95% CI 1.80, 3.42; recommend in future: OR 1.92, 95% CI 1.37, 2.69). Implementing clinical decision support was not associated with discussing trials with ≥25% of patients (OR 1.12, 95% CI 0.76, 1.67), but was associated with being likely to recommend a trial in the future (OR 1.73, 95% CI 1.11, 2.71). Conclusions: In a national survey of oncologists, we observed differences in physician practices and intention related to clinical trial accrual. Whereas the vast majority (80%) reported being likely or very likely to recommend trials in the future, far fewer (20%) reported discussing trials with their patients within the past 5 years. Implementation of clinical decision support – electronic tools intended to optimize patient care and identification of patient eligibility – was not associated with frequency of past discussion of clinical trials but was associated with recommending a trial in the future. Given the stronger association between experience as a site Principal Investigator and recommending a trial, future research should explore how improving opportunities to lead a clinical trial impact trial accrual.

Identification of Cancer Care and Protocol Characteristics Associated With Recruitment in Breast Cancer Clinical Trials

2008 ◽  
Vol 26 (27) ◽  
pp. 4458-4465 ◽  
Author(s):  
Julie Lemieux ◽  
Pamela J. Goodwin ◽  
Kathleen I. Pritchard ◽  
Karen A. Gelmon ◽  
Louise J. Bordeleau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Primary Objective ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Number Of Patients ◽  
Trial Protocols ◽  
Few Data

Purpose It is estimated that only 5% of patients with cancer participate in a clinical trial. Barriers to participation may relate to available protocols, physicians, and patients, but few data exist on barriers related to cancer care environments and protocol characteristics. Methods The primary objective was to identify characteristics of cancer care environments and clinical trial protocols associated with a low recruitment into breast cancer clinical trials. Secondary objectives were to determine yearly recruitment fraction onto clinical trials from 1997 to 2002 in Ontario, Canada, and to compare recruitment fraction among years. Questionnaires were sent to hospitals requesting characteristics of cancer care environments and to cooperative groups/pharmaceutical companies for information on protocols and the number of patients recruited per hospital/year. Poisson regression was used to estimate the recruitment fraction. Results Questionnaire completion rate varied between 69% and 100%. Recruitment fraction varied between 5.4% and 8.5% according to year. More than 30% of patients were diagnosed in hospitals with no available trials. In multivariate analysis, the following characteristics were associated with recruitment: use of placebo versus not (relative risk [RR] = 0.80; P = .05), nonmetastatic versus metastatic trial (RR = 2.80; P < .01), and for nonmetastatic trials, protocol allowing an interval of 12 weeks or longer versus less than 12 weeks (from diagnosis, surgery, or end of therapy) before enrollment (RR = 1.36; P < .01). Conclusion Allowable interval of 12 weeks or longer to randomly assign patients in clinical trials could help recruitment. In our study, absence of an available clinical trial represented the largest barrier to recruitment.

scholarly journals Clinical Trial Accrual Targeting Genomic Alterations After Next-Generation Sequencing at a Non-National Cancer Institute–Designated Cancer Program

2016 ◽  
Vol 12 (4) ◽  
pp. e396-e404 ◽  
Author(s):  
Kalyan C. Mantripragada ◽  
Adam J. Olszewski ◽  
Andrew Schumacher ◽  
Kimberly Perez ◽  
Ariel Birnbaum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Next Generation Sequencing ◽  
National Cancer Institute ◽  
Next Generation ◽  
Genomic Alterations ◽  
Cancer Centers ◽  
Cancer Program ◽  
Clinical Trial Accrual ◽  
Generation Sequencing

Purpose: Successful clinical trial accrual targeting uncommon genomic alterations will require broad national participation from both National Cancer Institute (NCI)–designated comprehensive cancer centers and community cancer programs. This report describes the initial experience with clinical trial accrual after next-generation sequencing (NGS) from three affiliated non–NCI-designated cancer programs. Materials and Methods: Clinical trial participation was reviewed after enrollment of the first 200 patients undergoing comprehensive genomic profiling by NGS as part of an institutional intuitional review board–approved protocol at three affiliated hospitals in Rhode Island and was compared with published experience from NCI-designated cancer centers. Results: Patient characteristics included a median age of 64 years, a median of two lines of prior therapy, and a predominance of GI carcinomas (58%). One hundred sixty-four of 200 patients (82%) had adequate tumor for NGS, 95% had genomic alterations identified, and 100% had variants of unknown significance. Fifteen of 164 patients (9.2%) enrolled in genotype-directed clinical trials, and three patients (1.8%) received commercially available targeted agents off clinical trials. The reasons for nonreceipt of NGS-directed therapy were no locally available matching trial (48.6%), ineligibility (33.6%) because of comorbidities or interim clinical deterioration, physician's choice of a different therapy (6.8%), or stable disease (11%). Conclusion: This experience demonstrates that a program enrolling patients in specific targeted agent clinical trials after NGS can be implemented successfully outside of the NCI-designated cancer program network, with comparable accrual rates. This is important because targetable genes have rare mutation rates and clinical trial accrual after NGS is low.

Cancer clinical trial accrual patterns among community cancer centers in the United States

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6041-6041
Author(s):  
J. A. Lee ◽  
M. A. Mathiason ◽  
C. A. Czeczok ◽  
J. K. Keller ◽  
R. S. Go
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Cancer Patients ◽  
The United States ◽  
Cooperative Groups ◽  
Medical Support ◽  
Cancer Centers ◽  
Number Of Patients ◽  
Clinical Trial Accrual ◽  
The U.S

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.

Barriers to clinical trial accrual: Clinical trialists' perspectives.

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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