Promoting clinical research to medically underserved communities: Current practices and perceptions about clinical trial recruiting strategies

Tanner, Andrea; Kim, Sei‐Hill; Friedman, Daniela B.; Foster, Caroline; Bergeron, Caroline D.

doi:10.1016/j.cct.2014.12.010

Cited by 36 publications

(32 citation statements)

References 24 publications

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“…According to our survey, altruism followed by personal and monetary benefits were the most frequently reported motivating factor in research participation across all nationalities. These findings compliment evidence found in previous literature [20] , [21] , [22] . Altruism has moral and ethical roots and may impart a sense of fulfillment or usefulness to the participants [22] .…”

Section: Discussionsupporting

confidence: 93%

“…While time has widely been reported as one of the prime barriers in participation in clinical research, ‘fear’, ‘mistrust’ and ‘misconceptions’ have been more thoroughly explored in the literature [7] , [13] , [14] , [15] , [16] , [20] , [21] . Our survey showed that among those who reported ‘fear’ and ‘mistrust’ as a reason for refusal to participate belonged mostly to Qatari and other Arab nationalities.…”

Section: Discussionmentioning

confidence: 99%

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Perceptions and attitudes to clinical research participation in Qatar

Tohid

Choudhury

Agouba

et al. 2017

Contemporary Clinical Trials Communications

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Recruitment into clinical research studies is a major challenge. This study was carried out to explore the perceptions and attitudes towards clinical research participation among the general public in Qatar. A population based questionnaire study was carried out at public events held in Qatar. Residents of Qatar, 18 years or above in age were surveyed, anonymously, following verbal consent. Descriptive and multivariate analyses were conducted. We administered 2517 questionnaires to examine clinical research participation, of which 2379 complete forms were analyzed. Those who had previously been approached to participate in research completed a more detailed assessment. Data showed that only 5.7% participants (n = 134) had previously been approached to participate in a clinical research study. Of these 63.4% (n = 85) had agreed to participate while 36.6% (n = 49) had declined. The main reasons for declining participation included: time constraint (47.8%, n = 11), ‘fear’ (13.0%, n = 3), lack of awareness about clinical research (8.7%, n = 2) and lack of interest (8.7%, n = 2). ‘To help others’ (31.8%, n = 27) and ‘thought it might improve my access to health care’ (24.7%, n = 21) were the prime motivators for participation. There was a general agreement among participants that their previous research experience was associated with positive outcomes for self and others, that the research conduct was ethical, and that opportunities for participation will be welcomed in future. More than ten years of stay within Qatar was a statistically significant determinant of willingness to participate, adjusted odds ratio 5.82 (95% CI 1.93–17.55), p = 0.002. Clinical research participation in Qatar needs improvement. Time constraints, lack of trust in and poor awareness about clinical research are main barriers to participation. Altruism, and improved health access are reported as prime motivators. Deeper insight in to the factors affecting clinical research participation is needed to devise evidence based policies for improvement in recruitment strategies.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Perceptions and attitudes to clinical research participation in Qatar

Tohid

Choudhury

Agouba

et al. 2017

Contemporary Clinical Trials Communications

View full text Add to dashboard Cite

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“…Participation in clinical trials is known to be affected by structural factors, such as geography and tertiary care center access, and has traditionally resulted in remote and rural populations being underrepresented in clinical research . In the United States, about 60 million people, or 19.3% of the population, live in a rural area .…”

Section: Discussionmentioning

confidence: 99%

Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

Bobb

Heukelom

Faine

et al. 2016

Academic Emergency Medicine

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Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face-to-face consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials.

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“…Recruitment and retention of an appropriate and representative study sample enhance the validity of the results and heighten the potential public health impact. [ 3 , 4 ] Despite the benefits of clinical research, many people approached to participate decline to do so because of deeply rooted myths about research. [ 5 , 6 ] Physician-scientists and basic/translational scientists need to work together to dispel these misconceptions so that enhanced participant enrollment can be attained, a step that is vital to conducting a successful clinical trial.…”

Section: Introductionmentioning

confidence: 99%

Socio-ecological Model as a Framework for Overcoming Barriers and Challenges in Randomized Control Trials in Minority and Underserved Communities

et al. 2014

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Background:Numerous barriers and challenges can hinder the successful enrollment and retention of study participants in clinical trials targeting minority populations. To conduct quality research, it is important to investigate these challenges, determine appropriate strategies that are evidence-based and continue seeking methods of improvement.Methods:In this paper, we report such experiences in a registered clinical trial in an underserved minority population in the Southern part of United States. This research study is a randomized double-blind controlled clinical trial that tests the efficacy of higher-strength as compared to low-strength/standard of care folic acid to prevent fetal body and brain size reduction in pregnant women who smoke. A unique approach in this socio-behavioral, genetic-epigenetic clinical trial is that we have adopted the socio-ecological model as a functional platform to effectively achieve and maintain high participant recruitment and retention rates.Results:We highlight the barriers we have encountered in our trial and describe how we have successfully applied the socio-ecological model to overcome these obstacles.Conclusions and Global Health Implications:Our positive experience will be of utility to other researchers globally. Our fi ndings have far-reaching implications as the socio-ecological model approach is adaptable to developed and developing regions and has the potential to increase recruitment and retention of hard-to-reach populations who are typically under-represented in clinical trials.

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Promoting clinical research to medically underserved communities: Current practices and perceptions about clinical trial recruiting strategies

Cited by 36 publications

References 24 publications

Perceptions and attitudes to clinical research participation in Qatar

Perceptions and attitudes to clinical research participation in Qatar

Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

Socio-ecological Model as a Framework for Overcoming Barriers and Challenges in Randomized Control Trials in Minority and Underserved Communities

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