Article
The likelihood of participation in clinical trials can be measured: the Clinical Research Involvement Scales.
Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA 30030, USA.
Journal of clinical epidemiology (impact factor:
2.96).
03/2010;
63(10):1110-7.
DOI:10.1016/j.jclinepi.2009.12.002
pp.1110-7
Source: PubMed
- Citations (4)
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Cited In (0)
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Article: Perceptions of clinical research participation among African American women.
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ABSTRACT: Recruiting minority women into clinical research remains a significant challenge to conducting ethnically representative research. The main objective of this Office on Women's Health, DHHS-funded e-health database evaluation project was to examine African American women 's thoughts and perceptions about the clinical research process and about participation in the University of Michigan Women's Health Registry research database. Thirty-one African American women were recruited from the community to participate in a total of five 90-minute focus group discussions. All sessions were audiotaped and transcribed verbatim. Thematic content analysis was used to identify relevant themes about participation in clinical research and the Women's Health Registry. Ten common trends were identified. (1) Information about the Women's Health Registry is not reaching the community. (2) Research is perceived as biased to benefit Caucasians. (3) Community involvement by the research team is critical for trust to develop. (4) Research directly relevant to African Americans or their community will encourage participation. (5) Researchers should use existing networks and advertise in appropriate locations. (6) The community needs more information concerning research. (7) Compensation is important. (8) Research that addresses a personal or family medical problem encourages involvement. (9) Minority representation on the research team is a motivator to participation. (10) There is limited time for healthcare-related activities. Successful recruitment strategies for African American women should feature community-based, culturally appropriate approaches. Online research databases for subject recruitment will likely be successful only if implemented within a broader community-oriented program.Journal of Women s Health 05/2007; 16(3):423-8. · 1.57 Impact Factor -
Article: Public attitudes toward participation in cancer clinical trials.
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ABSTRACT: The objective of this study is to understand the attitudes of American adults toward participation in cancer clinical trials. A national probability sample of 1,000 adults aged 18 and older living in noninstitutional settings was interviewed by telephone by Harris Interactive during March and April 2000. One participant was selected from each household selected for the study. The resulting data were weighted to reflect the full adult population of the United States as reported in Current Population Reports. An Index of Participation in a Cancer Clinical Trial was computed, using a confirmatory factor analysis and converting the factor scores into a 0-to-100 scale. Approximately 32% of American adults (64 million individuals) indicate that they would be very willing to participate in a cancer clinical trial if asked to do so. An additional 38% of adults (76 million individuals) scored in a range that indicates that they are inclined to participate in a cancer clinical trial if asked, but hold some questions or reservations about participation. Projected rates of diagnosis, eligibility, and recruitment indicate that substantially more patients are willing to participate than are actually accrued. These results indicate that the primary problem with accrual is not the attitudes of patients, but rather that the loss of potential participants is the result of the unavailability of an appropriate clinical trial and the disqualification of large numbers of patients. The pool of willing patients is further reduced by the reluctance of some physicians to engage in accrual.Journal of Clinical Oncology 04/2003; 21(5):830-5. · 18.37 Impact Factor -
Article: Participation in cancer clinical trials: race-, sex-, and age-based disparities.
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ABSTRACT: Despite the importance of diversity of cancer trial participants with regard to race, ethnicity, age, and sex, there is little recent information about the representation of these groups in clinical trials. To characterize the representation of racial and ethnic minorities, the elderly, and women in cancer trials sponsored by the National Cancer Institute. Cross-sectional population-based analysis of all participants in therapeutic nonsurgical National Cancer Institute Clinical Trial Cooperative Group breast, colorectal, lung, and prostate cancer clinical trials in 2000 through 2002. In a separate analysis, the ethnic distribution of patients enrolled in 2000 through 2002 was compared with those enrolled in 1996 through 1998, using logistic regression models to estimate the relative risk ratio of enrollment for racial and ethnic minorities to that of white patients during these time periods. Enrollment fraction, defined as the number of trial enrollees divided by the estimated US cancer cases in each race and age subgroup. Cancer research participation varied significantly across racial/ethnic and age groups. Compared with a 1.8% enrollment fraction among white patients, lower enrollment fractions were noted in Hispanic (1.3%; odds ratio [OR] vs whites, 0.72; 95% confidence interval [CI], 0.68-0.77; P<.001) and black (1.3%; OR, 0.71; 95% CI, 0.68-0.74; P<.001) patients. There was a strong relationship between age and enrollment fraction, with trial participants 30 to 64 years of age representing 3.0% of incident cancer patients in that age group, in comparison to 1.3% of 65- to 74-year-old patients and 0.5% of patients 75 years of age and older. This inverse relationship between age and trial enrollment fraction was consistent across racial and ethnic groups. Although the total number of trial participants increased during our study period, the representation of racial and ethnic minorities decreased. In comparison to whites, after adjusting for age, cancer type, and sex, patients enrolled in 2000 through 2002 were 24% less likely to be black (adjusted relative risk ratio, 0.76; 95% CI, 0.65-0.89; P<.001). Men were more likely than women to enroll in colorectal cancer trials (enrollment fractions: 2.1% vs 1.6%, respectively; OR, 1.30; 95% CI, 1.24-1.35; P<.001) and lung cancer trials (enrollment fractions: 0.9% vs 0.7%, respectively; OR, 1.23; 95% CI, 1.16-1.31; P<.001). Enrollment in cancer trials is low for all patient groups. Racial and ethnic minorities, women, and the elderly were less likely to enroll in cooperative group cancer trials than were whites, men, and younger patients, respectively. The proportion of trial participants who are black has declined in recent years.JAMA The Journal of the American Medical Association 06/2004; 291(22):2720-6. · 30.03 Impact Factor
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Keywords
0.918. Confirmatory factor analysis
41-item CRIS instrument
adequate comprehension
biomedical research studies
Clinical Research Involvement Scales
clinical research organization
clinical research participation
clinical trials
community attitudes
CRIS subscales
formative phase
item-factor relationships
multiple time points
potential vaccine trial participants
recruit diverse populations
research endeavor
scale reliability
scales
square error
stable measurement improvement
