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Identification of accrual barriers onto breast cancer prevention clinical trials: a case-control study.

ABSTRACT: The purpose of this study was to examine factors influencing a woman's decision to participate in a breast cancer prevention clinical trial. Nine healthcare organizations in Massachusetts cooperated in the present project.The authors performed a case-control study to compare responses between the study group (Study of Tamoxifen and Raloxifene [STAR] trial eligible, but not enrolled) and the control group (STAR trial participants) on 12 factors previously identified as barriers to accrual for clinical trials. Eight hypotheses were tested using multiple logistic regression to estimate the strength of the association for each factor on the dependent variable (study participation).The study samples were similar to the general population of eligible breast cancer prevention clinical trial subjects in the counties where the participating organizations were located, the state of Massachusetts, and nationally published STAR trial data. Results of a mailed questionnaire showed that when adjusting for subject demographics, and in the presence of other questions, 4 factors significantly influenced a woman's decision to enroll onto a breast cancer prevention clinical trial more than other eligible subjects: 1) clinician expertise and qualifications (P=.012; odds ratio [OR], 4.903; 95% confidence interval [CI], 1.41-17.04); 2) personal desire to participate (P=.033; OR, 3.16; 95% CI, 1.10-9.06); 3) perceived value of the trial (P=.020; OR, 2.92; 95% CI, 1.18-7.21); and 4) level of trial inconvenience (P=.002; OR, 0.10; 95% CI, 0.02-0.44).Addressing these issues in the relationship between patients and clinicians should improve accrual to breast cancer prevention clinical trials.

SUBMITTER: Houlihan RH

PROVIDER: S-EPMC3077438 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

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Identification of accrual barriers onto breast cancer prevention clinical trials: a case-control study.

Houlihan Robert H RH Kennedy Michael H MH Kulesher Robert R RR Lemon Stephenie C SC Wickerham D Lawrence DL Hsieh Chung-Cheng CC Altieri Dario C DC

Cancer 20100801 15

<h4>Background</h4>The purpose of this study was to examine factors influencing a woman's decision to participate in a breast cancer prevention clinical trial. Nine healthcare organizations in Massachusetts cooperated in the present project.<h4>Methods</h4>The authors performed a case-control study to compare responses between the study group (Study of Tamoxifen and Raloxifene [STAR] trial eligible, but not enrolled) and the control group (STAR trial participants) on 12 factors previously identi ...[more]

PMID: 20564133

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Project description:BACKGROUND: Poor accrual is a significant barrier to the successful completion of oncology clinical trials; half of all phase 3 oncology trials close due to insufficient accrual. Timely access to accrual data fosters an understanding of successful trial design and can be used to inform the design of new clinical trials prospectively. Accrual statistics are available within research networks, such as the cancer cooperative groups, but comprehensive data reflecting the overall portfolio of cancer clinical trials are lacking. As a demonstration case, the purpose of this study was to quantify the public availability of accrual data across all recent renal cell carcinoma (RCC) trials. METHODS: The database for the Aggregate Analysis of ClinicalTrials.gov (AACT) summarizes all trials registered between October 2007 and September 2010. In total, 108 trials of pharmacologic therapy for RCC were included. Accrual data on these trials were gathered via ClinicalTrials.gov (CTG), a manual review of resulting publications, and online surveys sent to principle investigators or trial coordinators. RESULTS: In total, 26% (20 of 76) of trials listing a government, academic, or cooperative group (GAC) sponsor responded to the survey vs 0% (0 of 32) of those listing only industry sponsors. Across all methods, accrual data were available for only 40% (43 of 108) of trials, including 37% (28 of 76) of GAC trials and 47% (15 of 32) of industry trials. Moreover, 87% (66 of 76) of GAC trials were ongoing (open, actively recruiting, or of unknown status) vs 75% (24 of 32) of industry trials, while 9% (10 of 108) of trials were terminated or suspended. CONCLUSIONS: Despite extensive efforts (surveys, phone calls, CTG abstraction, publication searches), accurate accrual data remained inaccessible for 60% of the RCC trial cohort. While CTG reports trial results, ongoing accrual data are also critically needed. Poor access to accrual data will continue to limit attempts to develop a national summary of clinical trials metrics and to optimize the cancer clinical research portfolio.

Project description:BACKGROUND:There are multiple known individual- and practice-level barriers to enrollment of older patients with cancer to clinical trials, but little is known about how the clinical research workforce feels about potential higher-level strategy changes aimed to promote increased enrollment of older patients. SUBJECTS, MATERIALS, AND METHODS:We invited all 11,351 Alliance for Clinical Trials in Oncology ("Alliance") members to participate in an anonymous, web-based survey to examine awareness of current accrual patterns for older patients to clinical trials, to ascertain consensus on how to tackle enrollment challenges, and to provide the impetus for high-level changes to improve clinical trial accrual of older patients with cancer. RESULTS:During the period from February 28, 2017, to June 16, 2017, 1,146 Alliance members participated (response rate?= 10%), including a national diverse sample of physicians, nurses, administrative/clinical research staff, and patient advocates with representation from community, academic, and rural sites. Overall, one third felt that >50% of clinical trial enrollees should be age ?65, and 64.9% felt the Alliance could improve upon enrollment of older patients. The four most commonly ranked strategies to improve enrollment of older patients were creating more dedicated trials for this population (36.3%), minimizing exclusion criteria focused on comorbidity (35.5%), developing independent strategies for those aged ?65 and for those aged ?70 (33.2%), and requiring that most/all Alliance trials have a specific expansion cohort of older patients (30.0%). CONCLUSION:We anticipate that the recommendations from >1,000 Alliance members will continue to propel important strategy changes aimed to improve accrual of older patients with cancer to clinical trials. IMPLICATIONS FOR PRACTICE:This survey of the Alliance for Clinical Trials membership sought opinions on potential, large-scale, national strategies to improve accrual of older adults with cancer. Consensus was found around multiple strategies, including creating more dedicated trials for older patients, developing less stringent eligibility criteria, and mandating expansion cohorts of older patients within broader Alliance trials. It is anticipated that the recommendations from >1,000 Alliance members will continue to propel important strategy changes aimed to improve accrual of older patients with cancer to clinical trials.

Dataset Information

Identification of accrual barriers onto breast cancer prevention clinical trials: a case-control study.

Publications

Identification of accrual barriers onto breast cancer prevention clinical trials: a case-control study.

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