Patient perceptions and willingness to participate in clinical trials

Igwe, Elena; Woodburn, Julie; Davolos, Jacyln; Shollenberger, Cori; Miller, Suzanne M.; Hernández, Enrique; Ferriss, J. Stuart

doi:10.1016/j.ygyno.2016.06.015

Cited by 20 publications

(16 citation statements)

References 16 publications

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“…However, this was not the case. Nor did we observe enrollment differences by race, similar to the findings of Igwe et al in a study of gynecologic oncology patients [10] .…”

Section: Discussionsupporting

confidence: 89%

Characteristics of cancer patients participating in presurgical lifestyle intervention trials exploring effects on tumor biology

Dasher

Frugé²,

Snyder

et al. 2017

Contemporary Clinical Trials Communications

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BackgroundPoor diet and insufficient physical activity are strongly associated with an increased risk of several cancers. Preclinical studies suggest that lifestyle modifications may exert favorable effects on tumor biology. Randomized controlled trials in the presurgical setting serve as an ideal means to translate this research to humans; however, little is known about the characteristics of patients who enroll in these presurgical trials versus those who do not.MethodsScreening databases from three presurgical lifestyle intervention trials for breast and prostate cancer patients conducted at Duke University Medical Center (NCT00049309) and the University of Alabama at Birmingham (NCT02224807 and NCT01886677) were combined for analysis. Demographic and anthropometric differences between enrolled vs. non-enrolled individuals were assessed using Chi-square for categorical variables and t-tests for continuous variables.ResultsThere was no difference in participation rate when comparing minority status or overweight and obese patients. However, obese females were slightly more likely to enroll than women who were overweight (p = 0.110), a trend not seen in men. Women were also less likely than men to participate if their study site was >25 miles from their home (p = 0.034). Patients who had completed a college degree were somewhat less likely to enroll than those with less educational attainment (p = 0.072). Of those who did not enroll, 80% cited a lack of time.ConclusionSimilar to other clinical trials, lack of time is a leading barrier to enrollment, and travel/distance appears to be a greater barrier for women in presurgical studies. Larger presurgical lifestyle intervention trials will require tailored strategies to enhance recruitment.

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“…However, this was not the case. Nor did we observe enrollment differences by race, similar to the findings of Igwe et al in a study of gynecologic oncology patients [10] .…”

Section: Discussionsupporting

confidence: 89%

Characteristics of cancer patients participating in presurgical lifestyle intervention trials exploring effects on tumor biology

Dasher

Frugé²,

Snyder

et al. 2017

Contemporary Clinical Trials Communications

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“…However, we found that women and patients with poor knowledge concerning their disease were more likely to distrust pharmaceutical companies and are less willing to participate in industry-sponsored trials. This could at least partly explain underrepresentation of these sub-populations in industry-sponsored clinical trials and could be addressed by implementing educational strategies [34][35][36] as mentioned previously.…”

Section: Discussionmentioning

confidence: 99%

Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?

et al. 2020

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Background: Patient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research. The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results. Methods: This prospective, multicenter survey consisted in the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research (pre or post marketing, sponsored by an academic institution or pharmaceutical company). Logistic regression was used to determine factors contributing to "trust" versus "distrust" group membership and willingness to participate in each category of research. Results: One thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study. 48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female (p = 0.042), inactive in the employment market(p = 0.007), and not-knowing the name of one's disease(p = 0.010) are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.

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“…Third, a web-based questionnaire was developed to analyze factors influencing TIL trial participation. This was based on (i) aspects described in the accept/decline questionnaire of Penman and colleagues and the adapted version by Jenkins and colleagues, (ii) the Attitudes on Randomized Trials Questionnaire, 31 and (iii) factors described by Kaur and colleagues. 32 – 34 The questionnaire (Supplement 2, Supplemental Digital Content 1, http://links.lww.com/JIT/A514 ) was distributed via the Dutch patient association, “stichting Melanoom,” and aimed at advanced melanoma patients.…”

Section: Methodsmentioning

confidence: 99%

Treatment With Tumor-infiltrating Lymphocytes in Advanced Melanoma: Evaluation of Early Clinical Implementation of an Advanced Therapy Medicinal Product

Lindenberg

Retèl

Berg

et al. 2018

Journal of Immunotherapy

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Patient perceptions and willingness to participate in clinical trials

Cited by 20 publications

References 16 publications

Characteristics of cancer patients participating in presurgical lifestyle intervention trials exploring effects on tumor biology

Characteristics of cancer patients participating in presurgical lifestyle intervention trials exploring effects on tumor biology

Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?

Treatment With Tumor-infiltrating Lymphocytes in Advanced Melanoma: Evaluation of Early Clinical Implementation of an Advanced Therapy Medicinal Product

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