A Comparison of Patient Knowledge of Clinical Trials and Trialist Priorities

Cameron, Paul A.; Pond, Gregory R.; Xu, Rebecca; Ellis, Peter; Goffin, John R.

doi:10.3747/co.20.1323

Cited by 36 publications

(43 citation statements)

References 24 publications

(40 reference statements)

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“…Studies have found that English speakers have a low comprehension of clinical trial terminology and procedures. 12,24 Areas of potential confusion among clinical trial participants regardless of language include the nature and purpose of randomization 10,11,12,24 and the ability of participants to voluntarily withdraw from a study. 24 Even when patient protections are explained, some patients may worry that their safety is still at risk.…”

Section: Discussionmentioning

confidence: 99%

“…12,24 Areas of potential confusion among clinical trial participants regardless of language include the nature and purpose of randomization 10,11,12,24 and the ability of participants to voluntarily withdraw from a study. 24 Even when patient protections are explained, some patients may worry that their safety is still at risk. 10 It may be particularly challenging to address such concerns through the informed consent and study enrollment process when a patient does not speak English.…”

Section: Discussionmentioning

confidence: 99%

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Characteristics of clinical trials that require participants to be fluent in English

et al. 2015

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Background/Aims Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial. Methods We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with U.S. Census and American Community Survey data to investigate the association of English language restrictions with ZIP-code level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses. Results English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p<0.001 from Chi-squared test). Industry sponsored trials had low rates of English fluency requirements (1.8%) while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the U.S. had the highest regional English requirement rates (10.7%) while trials opening in more than one region had the lowest (3.3%, p<0.001). Since 1995, trials opening in ZIP-codes with larger Hispanic populations were less likely to have English fluency requirements (OR=0.92 for each 10 percent increase in proportion of Hispanics, 95% CI 0.86–0.98, p=0.013). Trials opening in ZIP-codes with more residents self-identifying as Black/African American (OR=1.87, 95% CI 1.36–2.58, p<0.001 for restricted cubic spline term) or Asian (OR=1.16 for linear term, 95% CI 1.07–1.25, p<0.001) were more likely to have English fluency requirements. ZIP-codes with higher poverty rates had trials with more English language restrictions (OR=1.06 for a 10 percent poverty rate increase, 95% CI 1.001–1.11, p=0.045). There was a statistically significant interaction between year and intervention type, such that the increase in English fluency requirements was more common for some interventions than for others. Conclusions The proportion of clinical trials registered with ClinicalTrials.gov that have English fluency requirements for study inclusion has been increasing over time. English language restrictions are associated with a number of characteristics, including the demographic characteristics of communities in which the sponsoring institutions are located.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Characteristics of clinical trials that require participants to be fluent in English

et al. 2015

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“…Our study was based on statements from HCPs and like several other studies reinforce the education of healthcare professionals on Clinical Research to boost recruitment rates (11). Another survey based study on the knowledge of CT (16) demonstrated that knowledge of participants on CT was limited especially on topics such as rationale of study, randomization and placebo and patient protection. Participants were less informed about the agencies conducting CT in Mauritius leading to the belief that CT was performed on a selection of people.…”

Section: Discussionmentioning

confidence: 85%

The Educational Need Among Healthcare Professionals in Mauritius

Jodheea-Jutton

Jheelan-Ramchandur²

2018

IAM

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“…While raising trial participation awareness is an important first step, the patient community also needs access to information about what it means to participate in research, including explanations on the trial process, different types of trials, the informed consent process and regulatory and patient protections that govern research [6]. This education must also include demystifying key myths that are long held beliefs, often deeply ingrained in the lay community.…”

Section: Dissecting the Problem: Why Is There Poor Participation In Cmentioning

confidence: 98%

“…Over 90% of enrolled PPMI subjects are Caucasian. Numerous papers have focused on the challenge of enrolling minorities in clinical research, so we will not delve into the potential reasons behind poor research participation rates, but it is a problem faced in PD as well as in other diseases [6]. Our experience with PPMI recruitment and minority enrollment is that broad tactics cannot be assumed to work for all groups and that a strong emphasis on how recruitment approaches ought to be tailored to be able to effectively communicate and conduct outreach to different communities should be part of every recruitment plan.…”

Section: ■ Case Study: the Parkinson's Progression Markers Initiativementioning

confidence: 99%

Improving patient participation in Parkinson‘s clinical trials: the experience of the Michael J Fox Foundation

Chowdhury¹,

Meunier²,

Cappelletti³

et al. 2014

Clinical Investigation

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Timely and efficient clinical trial recruitment is a chronic problem across diseases. The Michael J Fox Foundation for Parkinson's Research (MJFF) is a leading funder and sponsor of Parkinson's disease research. Solving recruitment challenges in Parkinson's disease is a priority for the MJFF and led to the development of an online tool -Fox Trial Finder -that connects participants to trials. As the sponsor of the Parkinson's Progression Markers Initiative, an observational biomarkers study, the MJFF developed first-hand expertise in recruitment planning and tactical implementation.Solving poor enrollment relies on all stakeholders involved -sponsors, funders, site personnel and patients -to work together to raise awareness of the problem and implement strategies to increase the number of people who participate in research.

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A Comparison of Patient Knowledge of Clinical Trials and Trialist Priorities

Abstract: by clinical trialists. The findings suggest that when developing education interventions, emphasis should be placed on the topics most directly related to patient care, and factors such as age and education level should be considered.

Cited by 36 publications

References 24 publications

Characteristics of clinical trials that require participants to be fluent in English

Characteristics of clinical trials that require participants to be fluent in English

The Educational Need Among Healthcare Professionals in Mauritius

Improving patient participation in Parkinson‘s clinical trials: the experience of the Michael J Fox Foundation

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