Research Ethics and the Ethics of Research: Should We Offer Clinical Trial Participation or Clinical Research Partnership to Oncology Patients in the New Millennium?

2007 ◽  
pp. 215-234
Author(s):  
Heather Sampson
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Research Ethics ◽  
Trial Participation ◽  
Research Partnership ◽  
Clinical Trial Participation ◽  
Oncology Patients ◽  
Ethics Of Research ◽  
New Millennium

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.

Breast cancer patients' willingness to travel to participate in a clinical trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14031-e14031 ◽  
Author(s):  
Nicholas Zdenkowski ◽  
James F. Lynam ◽  
Laura Wall ◽  
Scott Brown ◽  
Kathryn Wells ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Travel Time ◽  
Past History ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Patients ◽  
Early Stage Disease ◽  
National Breast

e14031 Background: The option of clinical trial participation is an important component of high quality care for oncology patients. Despite a recognised need for generalizable research results to guide future practice, and the desire of current oncology patients to participate in trials, only 2-5% of oncology patients in developed nations enroll in a clinical trial. We aimed to determine the willingness of patients to travel, change location and/or clinician to participate in a clinical trial. Methods: Members of a national breast cancer consumer organization were invited by email to respond to an online cross-sectional survey. Questions included demographics, remoteness of residence, prior involvement in clinical trials and location of usual care. This was followed by a Discrete Choice Experiment (DCE) comprising an introduction and 10 hypothetical scenarios to test the effect of variation in travel time, clinician, treating centre, travel cost and type of trial. Results: Between July and August 2016, 288 responses were received, mean age 58. 86% had early stage disease, 51% were currently receiving treatment, 21% had prior clinical trial involvement. Ninety percent were willing to participate in a clinical trial in at least one scenario. Factors that decreased the likelihood of interest in clinical trial participation were increasing travel time, change in oncologist and out of pocket expenses. Type of trial (randomised placebo controlled; randomised open label; single arm) did not influence the decision. If the oncologist remained the same and there were no costs, respondents were willing to travel a mean extra 127 minutes, however if the oncologist changed and there were additional costs, they were willing to travel a mean of 30 minutes. If the oncologist changed and there was no cost, they were willing to travel a mean of 82 minutes. Conclusions: This group of respondents with a past history of breast cancer expressed interest in clinical trial participation, however willingness to travel in the most likely scenario (change oncologist and pay no additional cost) was 82 minutes. To facilitate optimal access to clinical trials, clinicians should consider referral within and between institutions.

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.

Nationally representative estimates of the participation of cancer patients in clinical research studies according to the commission on cancer.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 74-74
Author(s):  
Joseph M. Unger ◽  
Mark Fleury
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Clinical Research ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Cancer Centers ◽  
Treatment Trials ◽  
Nationally Representative ◽  
Enrollment Data

74 Background: The successful conduct of cancer clinical trials hinges on the willingness of patients to participate. The rate of adult clinical trial participation has been regarded as being < 5%. However, national estimates of trial participation are nearly two decades old, and no evidence based on original data sources has been examined for many years. Moreover, studies about trial participation have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other key elements of clinical research, such as quality of life or biorepository studies. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from 1,200 institutions. Methods: The data were from the Commission on Cancer (CoC), a consortium of cancer-related organizations providing accreditation for both academic and community cancer care facilities across the U.S. CoC enrollment data represent 70% of all cases of cancer diagnosed each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality of life, registry, and screening studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (e.g., NCI-designated cancer programs) and pooled. Results: Across the entire U.S. system, the estimated participation rate to cancer treatment trials was 6.3%. Enrollment to treatment trials was highest at NCI-designated comprehensive cancer centers (18.9%), while for community cancer programs (CCPs) and comprehensive CCPs, treatment trial rates were 4.4% and 3.6%, respectively. Nearly 1 in 7 patients participated in biorepository studies (13.4%), including 39.4% at NCI cancer centers. Patients participated in a wide variety of other study types, including registry (8.1%), prevention (6.4%), genetic (3.6%), quality of life (2.9%), economic (2.7%), diagnostic (2.7%), and screening studies (1.8%). At least 25.4% of adult cancer patients were estimated to participate in one or more cancer clinical research studies. Conclusions: In a first-time use of nationally representative enrollment data from the CoC, enrollment to cancer treatment trials was 6.3%, higher than historical estimates of < 5%. Patients participated in a diverse set of other study types, and taken together, at least one quarter of patients participated in a study. Contributions of adult patients with cancer to clinical research is much more comprehensive than previously understood.

scholarly journals A Case-Control Study Examining Disparities in Clinical Trial Participation Among Breast Surgical Oncology Patients

2019 ◽  
Vol 4 (2) ◽  
Author(s):  
Oluwadamilola M Fayanju ◽  
Yi Ren ◽  
Samantha M Thomas ◽  
Rachel A Greenup ◽  
Terry Hyslop ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pacific Islander ◽  
Surgical Oncology ◽  
Trial Participation ◽  
Lower Income ◽  
Clinical Trial Participation ◽  
Oncology Patients ◽  
Asian Pacific Islander ◽  
Asian Pacific ◽  
Over Time

Abstract Background Clinical trial participation among racial and ethnic minorities remains low despite national efforts. We sought to determine how participation in clinical trials by breast surgical oncology patients has changed over time and what characteristics are associated with participation. Methods Women with breast cancer enrolled in National Cancer Institute–sponsored, cooperative-group trials from 2000 to 2012 and who underwent oncologic surgery (n = 17 125) were compared with trial-eligible women in the National Cancer Database diagnosed in 2000–2012 (n = 792 719). Race-specific trial participation was plotted over time by income and reported as a proportion of the combined cohorts. Factors associated with trial participation were estimated using logistic regression; we report odds ratios (ORs) with 95% confidence intervals (CIs). A P value less than  .05 was considered statistically significant for all analyses. All tests were two-sided. Results Participation declined across all groups over time because of a decrease in the scale and number of trials. In 2000–2003, Asian–Pacific Islander (7.17%), Hispanic (3.48%), and white (7.13%) patients from the highest income group had higher participation than their lower-income counterparts (Asian–Pacific Islander: 3.95%; Hispanic: 2.67%; white: 5.96%), but by 2008–2012, only high-income white patients participated more than lower-income whites (0.32% vs 0.25%, all P &lt; .01). Black (OR = 0.80, 95% CI = 0.75 to 0.85) and Hispanic (OR = 0.84, 95% CI = 0.77 to 0.92) patients were less likely to participate than whites, but there were statistically significant interactions between income and race and ethnicity, with high-income black patients being approximately 50% less likely to participate than lower-income blacks (all P &lt; .001). Conclusions Multifaceted interventions addressing the intersectionality of race, ethnicity, and other patient characteristics are needed to address persistent disparities in trial participation among breast surgical oncology patients.

Sign in / Sign up

Export Citation Format

Share Document