Identifying Barriers Associated With Enrollment of Patients With Lung Cancer into Clinical Trials

Horn, Leora; Keedy, Vicki L.; Campbell, Norma; Garcia, G.; Hayes, Amy; Spencer, Brady; Carbone, David P.; Sandler, Alan; Johnson, David H.

doi:10.1016/j.cllc.2012.03.008

Cited by 33 publications

(28 citation statements)

References 24 publications

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“…We were limited by the data points collected, but presumably, if more extensive criteria had been applied to the dataset, more and more patients would have been excluded. That 73% is close to what has been reported previously 32,33 . In fact, a study showed that the average number of trial eligibility criteria was about 23 19 , making it even more difficult to find eligible participants to enrol in clinical trials.…”

Section: Discussionsupporting

confidence: 77%

Are Clinical Trial Eligibility Criteria an Accurate Reflection of a Real-World Population of Advanced Non-Small-Cell Lung Cancer Patients?

et al. 2018

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Section: Discussionsupporting

confidence: 77%

Are Clinical Trial Eligibility Criteria an Accurate Reflection of a Real-World Population of Advanced Non-Small-Cell Lung Cancer Patients?

et al. 2018

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“…However, the clinical benefit of CT enrollment remains controversial [16,17,19]. In addition, reports addressing this issue have been either performed on small samples or were difficult to interpret [20,21]. However, most systematic analyses have agreed that although there is no evidence of a negative effect, there is limited evidence supporting a positive effect.…”

Section: Discussionmentioning

confidence: 98%

“…Scientific evidence favoring a clinical benefit of trial enrollment often reflects the favorable attributes of trial enrollees. For instance, previous studies have shown a difference in the protocol availability or eligibility by age, sex, or ethnicity [21,27]. Likewise, a retrospective review conducted among 1,042 patients with NSCLC showed the availability of protocols for NSCLC patients, but few are available for small cell lung cancer (63 vs. 48%; p < 0.001); similarly, patients with advanced disease were more likely to have an available protocol (p < 0.001) and to enter a study (p = 0.031).…”

Section: Discussionmentioning

confidence: 99%

“…Likewise, a retrospective review conducted among 1,042 patients with NSCLC showed the availability of protocols for NSCLC patients, but few are available for small cell lung cancer (63 vs. 48%; p < 0.001); similarly, patients with advanced disease were more likely to have an available protocol (p < 0.001) and to enter a study (p = 0.031). The most common reasons for patient exclusion were poor PS (32%) and comorbidities (27%) [21]. In our study, patients enrolled in any trial were more likely to have adenocarcinoma histology, EGFR mutation, a more advanced disease stage (IV vs. II-III), and a better ECOG PS (<2), and they were more frequently exposed to asbestos or having brain metastases at diagnosis, whereas patients outside any trial were more likely to be smokers.…”

Section: Discussionmentioning

confidence: 99%

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Survival of Patients with Advanced Non-Small Cell Lung Cancer Enrolled in Clinical Trials

et al. 2016

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Background: Up-to-date oncological therapy has been accomplished through the results of clinical trials (CTs). We analyzed the overall survival (OS) of patients with non-small cell lung cancer (NSCLC) and its relation to CT enrollment. Methods: The study included 1,042 patients with advanced NSCLC treated at the Instituto Nacional de Cancerología. All patients received treatment according to the national and international guidelines. Data were collected from medical records. Patients were subgrouped on the basis of their CT enrollment as follows: participants in any CT (ACT), exclusively intervention CTs (ICT) or exclusively pharmaceutical-sponsored CTs (PCT). Results: The CT enrollment effect was assessed through a multivariate Cox proportional hazards model. Thirty percent of the patients were in ACT, 28.3% in ICT and 13.7% in PCT. Female gender (p = 0.001), adenocarcinoma histology (p = 0.018), positive EGFR mutation (p = 0.006), and better ECOG performance status (<2) (p ≤ 0.0001) were more frequent in patients enrolled in CT; further, tobacco smoking (p ≤ 0.0001) and KRAS mutation (p = 0.001) were more frequent in patients who were not enrolled in a CT. Conclusion: Enrollment in ACT was associated with a better OS (hazard ratio: 0.47-0.74). NSCLC patients enrolled in a CT have an improved survival in an independent manner to other prognostic factors.

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“…1, 2). Although some barriers involve oncologists, health systems (3), or patient eligibility (4), another important cause of low enrollment may be lack of clinical trial awareness among cancer patients (5,6). Indeed, a survey of the general population found that 32% of adults would be "very willing" to participate in an oncologic clinical trial, and an additional 38% would be "inclined" to participate if provided more information (7).…”

Section: Introductionmentioning

confidence: 99%

Accessibility and Quality of Online Cancer-Related Clinical Trial Information for Naïve Searchers

Abel

Cronin

Earles

et al. 2015

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Although the Internet may help to increase cancer patients' awareness of clinical trials, little is known about the accessibility and quality of online clinical trial information. We simulated the experience of a na€ ve cancer patient without clinical trial knowledge by searching three popular search engines for treatment information for breast, lung, and prostate cancer, and myelodysplastic syndromes (MDS). Two coders independently evaluated website content for accessibility and quality. We screened 120 websites and identified 40 unique sites for analysis. Overall, 85% [95% confidence interval (CI), 70%-94%] of sites mentioned clinical trials on the landing page and 68% (51%-81%) included links to specific trials. Overall readability was poor. Approximately half of websites (36%-68%) included information on the potential benefits and risks of clinical trials and 40% provided information about when the site had been updated (25%-57%). Among sites with links to specific clinical trials, only 44% (25%-65%) provided an interactive interface that would allow patients to customize search results; breast (100%) and prostate (50%) sites were more interactive than lung (25%) and MDS (14%; P ¼ 0.007). Although cancer clinical trial information is widely available on the Internet, its quality is highly variable. Given the fact that many emerging cancer therapeutics are personalized based on disease or genomic characteristics, interactive web-based interfaces could serve as powerful vehicles to help patients locate appropriate clinical trials. Without enhanced efforts to ensure greater interactivity of cancer treatment websites, patient awareness of relevant clinical trials may remain low. Cancer Epidemiol Biomarkers Prev; 24(10); 1629-31. Ó2015 AACR.

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Identifying Barriers Associated With Enrollment of Patients With Lung Cancer into Clinical Trials

Cited by 33 publications

References 24 publications

Are Clinical Trial Eligibility Criteria an Accurate Reflection of a Real-World Population of Advanced Non-Small-Cell Lung Cancer Patients?

Are Clinical Trial Eligibility Criteria an Accurate Reflection of a Real-World Population of Advanced Non-Small-Cell Lung Cancer Patients?

Survival of Patients with Advanced Non-Small Cell Lung Cancer Enrolled in Clinical Trials

Accessibility and Quality of Online Cancer-Related Clinical Trial Information for Naïve Searchers

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