Barriers exist to patient participation in clinical trials

Guarino, Michael J.; Masters, Gregory A.; Schneider, Claudine; Biggs, David D.; Grubbs, Stephen S.; Himelstein, Andrew L.; Martin, Scott E.; Michaels, Leon; Guarino, Alfredo; Rejtos, L.

doi:10.1200/jco.2005.23.16_suppl.6015

Cited by 7 publications

(10 citation statements)

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“…Twenty-five were excluded, primarily because the studies included interventions to increase clinical trial accrual or were conducted in a non-US setting ( Figure 1 ; Supplementary Table 2 , available online). Thirty-five studies comprised of 9759 patients met our inclusion criteria ( Figure 2 ) ( 8 , 9 , 30–62 ). Most studies (n = 30, 85.7%) focused on treatment for cancer ( Table 1 ) ( 8 , 9 , 30–32 , 34 , 35 , 37 , 39 , 40 , 42–55 , 57–62 ).…”

Section: Resultsmentioning

confidence: 99%

“…Thirty-five studies comprised of 9759 patients met our inclusion criteria ( Figure 2 ) ( 8 , 9 , 30–62 ). Most studies (n = 30, 85.7%) focused on treatment for cancer ( Table 1 ) ( 8 , 9 , 30–32 , 34 , 35 , 37 , 39 , 40 , 42–55 , 57–62 ). Among the 5 cancer control studies, 4 focused on enrollment to cancer survivorship studies and 1 to a symptom management study ( Table 2 ) ( 33 , 36 , 38 , 41 , 56 ).…”

Section: Resultsmentioning

confidence: 99%

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“When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

Unger

Hershman

Till

et al. 2020

JNCI: Journal of the National Cancer Institute

160

106

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Background Patient participation in clinical trials is vital for knowledge advancement and outcomes improvement. Few adult cancer patients participate in trials. Although patient decision-making about trial participation has been frequently examined, the participation rate for patients actually offered a trial is unknown. Methods A systematic review and meta-analysis using 3 major search engines was undertaken. We identified studies from 1/1/2000-1/1/2020 that examined clinical trial participation in the U.S. Studies must have specified the numbers of patients offered a trial and the number enrolled. A random effects model of proportions was used. All statistical tests were two-sided. Results We identified 35 studies (30 about treatment trials and 5 about cancer control trials) among which 9,759 patients were offered trial participation. Overall, 55.0% (95% CI: 49.4% to 60.5%) of patients agreed to enroll. Participation rates did not differ between treatment (55.0%, 95% CI: 48.9% to 60.9%) and cancer control trials (55.3%, 95% CI: 38.9% to 71.1%, p=.98). Black patients participated at similar rates (58.4%, 95% CI: 46.8% to 69.7%) compared to White patients (55.1%, 95% CI: 44.3% to 65.6%, p=.88). The main reasons for non-participation were treatment choice or lack of interest. Conclusions More than half of all cancer patients offered a clinical trial do participate. These findings upend several conventional beliefs about cancer clinical trial participation, including that Black patients are less likely to agree to participate and that patient decision-making is the primary barrier to participation. Policies and interventions to improve clinical trial participation should focus more on modifiable systemic structural and clinical barriers, such as improving access to available trials and broadening eligibility criteria.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

Unger

Hershman

Till

et al. 2020

JNCI: Journal of the National Cancer Institute

160

106

View full text Add to dashboard Cite

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“…This study is the first to report on the association of self‐efficacy with decisional conflict in a CCT setting. Previous studies have focused either on delineating patient barriers, notably patient knowledge and attitudes towards CCTs , as well as concrete health system barriers such as physician attitudes and resource allocation. This study extends our current understanding of the impact of factors that affect CCT decision‐making through exploration of the role of decisional conflict and self‐efficacy and how these factors may impact patients' CCT choices.…”

Section: Discussionmentioning

confidence: 99%

The relationships among knowledge, self‐efficacy, preparedness, decisional conflict, and decisions to participate in a cancer clinical trial

et al. 2012

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Background Cancer clinical trials (CCTs) are important tools in the development of improved cancer therapies; yet, participation is low. Key psychosocial barriers exist that appear to impact a patient’s decision to participate. Little is known about the relationship among knowledge, self efficacy, preparation, decisional conflict, and patient decisions to take part in CCTs. Objective The purpose of this study was to determine if preparation for consideration of a CCT as a treatment option mediates the relationship between knowledge, self-efficacy, and decisional conflict. We also explored whether lower levels of decisional conflict are associated with greater likelihood of CCT enrollment. Method In a pre-post test intervention study, cancer patients (N=105) were recruited before their initial consultation with a medical oncologist. A brief educational intervention was provided to all patients. Patient self-report survey responses assessed knowledge, self efficacy, preparation for clinical trial participation, decisional conflict, and clinical trial participation. Results Preparation was found to mediate the relationship between self-efficacy and decisional conflict (p=0.003 for a test of the indirect mediational pathway for the Decisional Conflict total score). Preparation had a more limited role in mediating the effect of knowledge on decisional conflict. Further, preliminary evidence indicated that reduced decisional conflict was associated with increased clinical trial enrollment (p=0.049). Conclusions When patients feel greater CCT self-efficacy and have more knowledge they feel more prepared to make a CCT decision. Reduced decisional conflict, in turn, is associated with the decision to enroll in a clinical trial. Our results suggest that preparation for decision making should be a target of future interventions to improve participation in CCTs.

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“…Recent studies show that approximately 60% to 80% of patients presenting to community academic practices are not eligible for otherwise relevant studies. 4,35 Approximately half of the patients in this study raised concerns about the cost of participating in a clinical trial, and only 37% would be willing to travel for a clinical trial. Given that most cancer patients are not treated at academic medical centers, these data suggest a clear need for improving access to clinical trials in community settings.…”

Section: Figurementioning

confidence: 99%

Barriers to Clinical Trial Participation as Perceived by Oncologists and Patients

Meropol

Buzaglo

Millard

et al. 2007

J Natl Compr Canc Netw

116

118

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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.

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Barriers exist to patient participation in clinical trials

Cited by 7 publications

References 0 publications

“When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

“When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

The relationships among knowledge, self‐efficacy, preparedness, decisional conflict, and decisions to participate in a cancer clinical trial

Barriers to Clinical Trial Participation as Perceived by Oncologists and Patients

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