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      Factors affecting patient participation in clinical trials in Ireland: A narrative review

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          Abstract

          Objective

          Clinical trials have long been considered the ‘gold standard’ of research generated evidence in health care. Patient recruitment is an important determinant in the success of the trials, yet little focus is placed on the decision making process of patients towards recruitment. Our objective was to identify the key factors pertaining to patient participation in clinical trials, to better understand the identified low participation rate of patients in one clinical research facility within Ireland.

          Design

          Narrative literature review of studies focussing on factors which may act to facilitate or deter patient participation in clinical trials. Studies were identified from Medline, PubMed, Cochrane Library and CINAHL.

          Results

          Sixty-one studies were included in the narrative review: Forty-eight of these papers focused specifically on the patient's perspective of participating in clinical trials. The remaining thirteen related to carers, family and health care professional perspectives of participation. The primary factor influencing participation in clinical trials amongst patients was related to personal factors and these were collectively associated with obtaining a form of personal gain through participation. Cancer was identified as the leading disease entity included in clinical trials followed by HIV and cardiovascular disease.

          Conclusion

          The vast majority of literature relating to participation in clinical trials emanates predominantly from high income countries, with 63% originating from the USA. No studies for inclusion in this review were identified from low income or developing countries and therefore limits the generalizability of the influencing factors.

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          Most cited references46

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          Recruitment and participation in clinical trials: socio-demographic, rural/urban, and health care access predictors.

          Recruitment and participation in clinical trials by minorities, particularly African Americans and rural underserved populations, are low. This report examines predictors of clinical trial recruitment and participation for adult Marylanders. A cross-sectional design was used to survey 5154 adults (18 years and older) residing in 13 of the 24 jurisdictions in Maryland, including urban Baltimore City, and the rural regions of Western Maryland and the Eastern Shore. The survey, conducted between December 2001 and March 2003, used Computer-Assisted Telephone Interviewing and random-digit dialing procedures. Primary dependent variables included "ever asked to participate" (i.e., recruited) and "participated" in clinical trials. 11.1% of the respondents had been recruited to clinical trials. In addition, 59.4% of the respondents recruited to clinical trials actually participated in a clinical trial. Among respondents recruited to clinical trials, black and middle income respondents were significantly less likely to actually participate in clinical trials; whereas, respondents who received information about clinical trials from their health care provider, who were knowledgeable about clinical trials, and those who had the time commitment were significantly more likely to participate in clinical trials. These results suggest serious gaps in efforts to recruit racial/ethnic minorities and residents of rural regions into clinical trials. The findings provide the basis for the development and implementation of community-based educational programs for both the general public and health care professionals, and to enhance availability of community-based clinical trials, especially in the rural areas of the state.
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            Altruism among participants in cancer clinical trials.

            Patients' motivations for participation in cancer clinical trials are incompletely understood. Even less is known about the factors that influence participants' motivations for enrolling in trials. We studied the reasons why adult patients and parents of pediatric patients agree to participate in cancer trials. We focused on the role of altruism across all phases of trial. We surveyed adult patients and parents of pediatric patients participating in phase I, II, or III cancer clinical trials. We asked respondents why they agreed to enroll, and examined correlates of altruistic motivation using univariate and multivariate analyses. Among 205 adults and 48 parents of children participating in cancer trials, 47% reported that altruistic motivations were 'very important' to their decisions to enroll. In multivariate analysis with phase III trial participants as the reference group, phase I trial participants least often identified altruism as a 'very important' motivation for enrolling (phase I OR 0.4, 95% CI (confidence interval) 0.2-0.8; phase II OR 0.9, 95% CI 0.5-1.5, overall P = 0.017). Thirty-three respondents (13%) reported being motivated primarily by altruism. In multivariate analysis, participants with poor prognoses-defined as an expected 5-year disease-free survival of ≤ 10%-reported altruism as their primary motivation less often than those with better prognoses (OR 0.2, 95% CI 0.1-0.5, P = 0.001). Altruistic motivations did not differ between adult patients and parents of pediatric participants. The data are derived from related academic medical centers in one city, and the study sample reflects limited sociodemographic diversity, thereby limiting generalizability to other settings. Although cancer trial participants commonly report that altruism contributed to their decision to enroll, it is rarely their primary motivation for study participation. Participants in early phase trials and those with poor prognoses are least often motivated by altruism.
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              Barriers to the participation of African-American patients with cancer in clinical trials: a pilot study.

              African-American patients have been under-represented in oncology clinical trials. Better understanding barriers to African-American participation may help increase the accrual of African-American patients onto clinical trials. Two hundred eighteen patients with malignant disease (72 African-American patients and 146 white patients) were recruited from the Duke Cancer Clinic and from Duke Oncology Outreach Clinics (DOORS). Patients were interviewed using a standardized survey. Questions included patients' knowledge of cancer, religious/spiritual beliefs, satisfaction with medical care, knowledge of clinical trials, reasons for participating or refusing to participate in a clinical trial, financial/transportation issues, and demographic factors, such as age and education. Data on attitudes and belief were analyzed for group differences between African-American patients and white patients as well as between patients who were treated at the Duke Cancer Clinic and patients who were treated at DOORS clinics. Willingness to participate in a clinical trial depended on both race and clinic site. Forty-five percent of white patients, compared with 31% of African-American patients, were willing to participate in a clinical trial (P = 0.05). white and African-American patients who were treated at the Duke Cancer Clinic were more willing to participate in a trial compared with their counterparts who were treated at DOORS clinics (47% vs. 37%, respectively; P = 0.09). The greatest differences between groups (African-American patients vs. white patients and Duke Cancer Clinic patients vs. DOORS patients) were education and income: Much greater percentages of African-American patients and DOORS patients did not complete high school and had annual incomes < $15,000. In addition, more African-American patients than white patients believed that God would determine whether they would be cured or would die from their disease. In a multivariate analysis, education, income, and belief that God would determine the patient's outcome also were correlated with a decreased willingness to participate in clinical trials. Factors associated with religion, education, and income, rather than race, may be major barriers to clinical trial participation. Interventions that target education and income may increase the recruitment of African-American oncology patients onto clinical trials. Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11213
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                Author and article information

                Contributors
                Journal
                Contemp Clin Trials Commun
                Contemp Clin Trials Commun
                Contemporary Clinical Trials Communications
                Elsevier
                2451-8654
                02 March 2016
                15 August 2016
                02 March 2016
                : 3
                : 23-31
                Affiliations
                [a ]Irish Cancer Society, Northumberland Road, Dublin 4, Ireland
                [b ]University College Dublin, Belfield, Dublin 1, Ireland
                Author notes
                []Corresponding author. fog_face@ 123456yahoo.co.uk
                Article
                S2451-8654(15)30012-0
                10.1016/j.conctc.2016.01.002
                5935836
                29736453
                ffb0b99d-1c11-42a9-b717-b95c31d5d538
                © 2016 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 4 August 2015
                : 11 January 2016
                : 20 January 2016
                Categories
                Article

                clinical trials,participation,recruitment,patient factors,physician factors,ich gcp, international conference on harmonisation guidelines for good clinical practice,grace, gender race and clinical experience,rct, randomized control trials,usa, united states of america

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