scholarly journals Understanding the Barriers to Pediatric Oncologist Engagement and Accrual to Clinical Trials in National Cancer Institute–Designated Community Oncology Research Programs

2020 ◽  
pp. JOP.19.00707 ◽  
Author(s):  
David S. Dickens ◽  
Michael E. Roth ◽  
Brad H. Pollock ◽  
Anne-Marie Langevin
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Time Allocation ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Clinical Trial Research ◽  
Protected Time ◽  
Oncology Research ◽  
Community Oncology

PURPOSE: Clinical trial participation leads to progress in cancer care. Principal investigators (PIs) and clinical research associates (CRAs) play key roles in the provision and maintenance of clinical trial portfolios at their sites. Previous studies have evaluated the educational and resource needs of adult oncology providers, but nothing to date has focused on providers of pediatric oncology care. We aimed to identify the educational needs and clinical trial participation barriers at National Cancer Institute Community Oncology Research Program (NCORP) Children’s Oncology Group (COG) sites to improve the quality of site investigator engagement. METHODS: Quality improvement surveys of pediatric clinical research staff at NCORP sites were performed. The first was a web-based inquiry of NCORP COG PIs and lead CRAs to assess their general understanding of NCORP organizational structure and needs. The second survey of COG PIs was conducted by one-on-one telephone interviews aimed at identifying specific barriers to physician engagement and patient enrollment in clinical trial research. RESULTS: The majority of NCORP COG PIs and CRAs (63%) reported an incomplete understanding of NCORP structure, with approximately half expressing interest in developing stronger collaborations and engagement. Most NCORP COG PIs reported at least one shared barrier to clinical trial enrollment (78%), with inadequate protected time and research support (39% each) being the most frequently cited barriers. CONCLUSIONS: Contributions to pediatric cancer clinical research at COG NCORP sites could be enhanced through improved education, resources, and time allocation.

scholarly journals Challenges to National Cancer Institute–Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites

2010 ◽  
Vol 6 (3) ◽  
pp. 114-117 ◽  
Author(s):  
Allison R. Baer ◽  
Chelsey A. Kelly ◽  
Suanna S. Bruinooge ◽  
Carolyn D. Runowicz ◽  
Douglas W. Blayney
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Trial Participation ◽  
Cooperative Group ◽  
Clinical Trial Participation ◽  
Anecdotal Information

Anecdotal information regarding clinical research sites limiting participation in NCI-funded cooperative group studies prompted ASCO to collect data on and investigate the reasons behind this trend.

Transforming the site feasibility assessment process for oncology clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14092-e14092
Author(s):  
Dax Kurbegov ◽  
Patricia A. Hurley ◽  
David Michael Waterhouse ◽  
Grzegorz S. Nowakowski ◽  
Edward S. Kim
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Task Force ◽  
Assessment Process ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Contract Research Organization ◽  
Feasibility Assessment ◽  
Oncology Research ◽  
Start Up

e14092 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.

scholarly journals Assessment of Perceived Cost to the Patient and Other Barriers to Clinical Trial Participation

2011 ◽  
Vol 7 (5) ◽  
pp. 330-333 ◽  
Author(s):  
Douglas J. Weckstein ◽  
Christian A. Thomas ◽  
Ivette F. Emery ◽  
Barbara F. Shea ◽  
Alison Fleury ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
New England ◽  
Trial Participation ◽  
Random Assignment ◽  
Clinical Trial Participation ◽  
Community Oncology

Concerns about adverse effects and random assignment were the most common reasons cited by patients declining trial participation in four community oncology practices in New England.

Barriers to Clinical Trial Participation as Perceived by Oncologists and Patients

2007 ◽  
Vol 5 (8) ◽  
pp. 753-762 ◽  
Author(s):  
Neal J. Meropol ◽  
Joanne S. Buzaglo ◽  
Jennifer Millard ◽  
Nevena Damjanov ◽  
Suzanne M. Miller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Treatment Strategies ◽  
Background Information ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Clinical Trial Research ◽  
Psychosocial Barriers ◽  
Medical Oncologists

Although clinical trial research is required for the development of improved treatment strategies, very few cancer patients participate in these studies. The purpose of this study was to describe psychosocial barriers to clinical trial participation among oncologists and their cancer patients. A survey was distributed to all medical oncologists in Pennsylvania and a subset of their patients. Relevant background information and assessment of practical and psychosocial barriers to clinical trial participation were assessed. Among 137 oncologists and 170 patients who completed the surveys, 84% of patients were aware of clinical trials, and oncologists and patients generally agreed that clinical trials are important to improving cancer treatment. However, oncologists and patients were more likely to consider clinical trials in advanced or refractory disease. When considering 7 potential barriers to clinical trials, random assignment and fear of receiving a placebo were ranked highly by both patients and oncologists. Patients identified fear of side effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as least important to their patients. Overall, the study found that although oncologists and patients are aware of clinical trials and have favorable attitudes toward them, psychosocial barriers exist for patients that may impact participation in clinical trials. Furthermore, important discrepancies exist between the perceptions of oncologists and those of patients regarding what the psychosocial barriers are. We concluded that characterizing oncologist and patient perceived barriers can help improve communication and decision making about clinical trials, such that participation may be optimized.

Impact of nontreatment oncology research trials on physician engagement in clinical research in an oncology community practice setting.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 44-44
Author(s):  
Susan S. Night ◽  
Juston S. Roemisch ◽  
David A. Smith
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Negative Impact ◽  
Rapid Development ◽  
Treatment Options ◽  
Community Practice ◽  
Oncology Research ◽  
Community Oncology ◽  
Physician Engagement

44 Background: The rapid development of new oncology drugs has created a significant increase in the number of clinical research studies. This underscores the need for greater participation in research by physicians as well as patients. Many physicians hesitate to participate in oncology clinical trials that provide treatment options for their patients given the complexity of the protocols. Non-treatment clinical trials may serve as a bridge for engaging physicians in clinical research and enhance the culture of research in community oncology practices. Methods: A large non-treatment oncology clinical trial was opened in a network of community oncology practices with approximately 1,000 physicians. We evaluated the number of physicians who did not enroll a patient onto a clinical trial in Year 1 but did enroll patients onto the non-treatment study. We further examined the number of physicians who enrolled a patient onto the non-treatment study that also enrolled patients onto a treatment clinical trial. Overall physician engagement in clinical research was measured by comparing practices where non-treatment study was offered to locations that did not participate in the non-treatment study. Negative impact on treatment accruals was also evaluated. Results: There were 105 physicians that practice at a site with the non-treatment study who had 0 accruals in Year 1 but enrolled a patient to any clinical trial in Year 2. Ninety-two of those physicians were responsible for enrolling over 900 patients to the non-treatment study in Year 2. Additionally, 46 of the 0 accruing physicians in Year 1, enrolled a patient to the non-treatment study also enrolled a patient to a treatment clinical trial. We also found that 24 physicians who did not did not enroll a patient in Year 1 and did not enroll a patient to the non-treatment study did enroll patients to a treatment clinical trial in Year 2. Conclusions: Participation in oncology treatment clinical trials can be difficult in the community oncology setting. Participation in a non-treatment study may serve as a bridge to engage more physicians in clinical research and enhance the culture of research within a community oncology practice.

scholarly journals A Screening Tool to Enhance Clinical Trial Participation at a Community Center Involved in a Radiation Oncology Disparities Program

2011 ◽  
Vol 7 (3) ◽  
pp. 161-164 ◽  
Author(s):  
Julian W. Proctor ◽  
Elaine Martz ◽  
Larry L. Schenken ◽  
Rebecca Rainville ◽  
Ursula Marlowe
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
National Cancer Institute ◽  
Radiation Oncology ◽  
Screening Tool ◽  
Community Center ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Center ◽  
Simple Screening

A simple screening tool was used to enhance clinical trial participation at a community radiation oncology center involved in a National Cancer Institute–funded disparities program but lacking on site clinical trials personnel.

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