Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment

Lara, Primo N.; Higdon, Roger; Lim, Nelson; Kwan, Karen; Tanaka, Michael; Lau, Derick H; Wun, Ted; Welborn, Jeanna L; Meyers, Frederick J.; Christensen, Scott; O’Donnell, Robert T.; Richman, Carol M.; Scudder, Sidney A.; Tuscano, Joseph M.; Gandara, David R.; Lam, Kit S.

doi:10.1200/jco.2001.19.6.1728

Cited by 515 publications

(487 citation statements)

References 10 publications

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“…The study was designed with an assumed clinical trial refusal rate of 40% which was based on an average from previous studies (Klabunde et al, 1999;Jenkins and Fallowfield, 2000;Lara et al, 2001). However, the observed refusal rate for clinical trials in this study of approximately 20% is substantially less than that reported in the literature.…”

Section: Discussionmentioning

confidence: 88%

“…Compared with earlier phase studies (Gordon and Daugherty, 2001), relatively high rates of patient refusal have been reported: 28% (Jenkins and Fallowfield, 2000), 40% (Klabunde et al, 1999) and 49% (Lara et al, 2001). Research undertaken in 'hypothetical trial' situations of chemotherapy have shown refusal rates of 40% (Sutherland et al, 1990) and 58% (Llewellyn- Thomas et al, 1991).…”

Section: Clinical Trials and Recruitmentmentioning

confidence: 87%

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A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55 -2.58, P ¼ 0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P ¼ 0.0072). The change in anxiety score between the arms was also statistically significant (P ¼ 0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.

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Section: Discussionmentioning

confidence: 88%

Section: Clinical Trials and Recruitmentmentioning

confidence: 87%

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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“…13,14,20,21,22,27 The dominant reason for ineligibility exclusions is likely exclusions due to comorbid conditions. One recent paper comprehensively catalogued the trial eligibility criteria for a set of 21 trials in diverse cancer settings.…”

Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

“…33 Since trials sometimes require more frequent monitoring than non-trial care, getting to and from a cancer clinic has been indicated by many patients to be a reason for non-participation. 15,20 Concern about how to pay for trials has been cited as a reason for non-participation among about a quarter of patients, despite the fact that the majority of states mandate that insurers cover the routine care costs of trials, as does Medicare. 15 In a review by Ford et al, cost concerns were identified as the second most frequently indicated reason for non-participation in trials in the literature.…”

Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Unger

Cook²,

Tai

et al. 2016

American Society of Clinical Oncology Educational Book

296

298

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OVERVIEW Fewer than 1 in 20 adult cancer patients enroll in cancer clinical trials. But although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. Barriers to trial participation are structural, clinical, and attitudinal, and differ according to demographic and socioeconomic factors. In this paper, we characterize the nature of cancer clinical trial barriers, and we consider global and local strategies for reducing barriers. We also consider the specific case of adolescents with cancer, and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared to other age groups. Our analysis suggests that a clinical trial system that enrolls patients at higher rates produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Fewer barriers to trial participation would allow trials to be completed more quickly and would improve the generalizability of trial results. Moreover, increased accrual to trials is important to patients, since trials provide patients the opportunity to receive the newest treatments. In an era of increasing emphasis on a treatment decision-making process that incorporates the patient perspective, the opportunity for patients to choose trial participation for their care is vital.

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“…A drug portfolio approach is a necessity, which is negotiated as a broad partnership or through a consortium strategy, and the ability to feasibly deliver the therapeutic through systems such as a centralised pharmacy are essential. The ability to offer patients and their clinicians a broad selection of attractive opportunities, where each patient has a real option, will enhance participation in clinical trials, increasing enrolment from the current dismal low proportion of some 2 to 5% of potentially eligible participants 66,67 We have made advances, but mostly through altering development strategies to fit with established healthcare systems, and progress has been slow. Perhaps it is time to ask if health care systems are out of pace with the science and the development process and as a consequence impeding therapeutic development?…”

Section: Participant Screening and Recruitmentmentioning

confidence: 99%

Patient-centric trials for therapeutic development in precision oncology

Biankin

Piantadosi

Hollingsworth

2015

Nature

238

182

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Our increasing understanding of the molecular pathology of disease, particularly through genomic studies, has created significant opportunities for the development of therapeutics that specifically target discrete molecular subclasses, but equally, has generated substantial challenges in how to develop and implement these strategies. Variously termed personalised, stratified, individualised or precision medicine, the approach is centered on delivering the optimal therapy for an individual based on specific clinical and molecular features of their disease. The development of new therapeutics that target molecular mechanisms has driven considerable change and innovation in clinical trial strategies. We have made progress through improved efficiency and changes in clinical trial design, yet continued innovation through the modification of existing core paradigms in oncology drug development and clinical care are required to fully realise the promise of precision medicine.

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Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment

Cited by 515 publications

References 10 publications

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Patient-centric trials for therapeutic development in precision oncology

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