Actual Enrollment Research Articles

Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review.

The success of military-relevant health research often depends on recruiting adequate numbers of U.S. military service members as research participants. Researchers have reported difficulties in recruiting service member research participants. Reviews of ClinicalTrials.gov, an online clinical trial registry of publicly and privately sponsored studies, have identified challenges in participant recruitment and barriers to study completion in various research populations. The purpose of this study was to identify indications of difficulty recruiting U.S. military service members as research participants based on data from study records in ClinicalTrials.gov. Records of studies starting between 2005 and 2014 were collected from ClinicalTrials.gov and updated through January 2016. Three hundred and two studies that included ≥25% U.S. military service member research participants were (1) compared to a comparison group of 302 studies, each with <5% service member participants and (2) compared by the proportion of service member participants within studies in the military group ("many" ≥25% but <100% service members and "all" 100% service members). Groups were evaluated and compared for recruitment status; reasons for study withdrawal, termination, or suspension; achievement of ≥85% of the anticipated enrollment; and differences in achieving recruitment goals according to study sponsor. Twelve percent of studies in the military group had been withdrawn, terminated, or suspended; enrollment and funding problems were the most common reasons. The comparison group had 11% of studies withdrawn, terminated, or suspended; the most common reasons were enrollment problems and sponsor decision. All study groups had indications of difficulty adequately achieving participant enrollment goals. Among studies with known anticipated and actual enrollment, approximately half in both the military group (47.9%) and comparison group (50.3%) achieved ≥85% of the anticipated enrollment (p = 0.722). Half of studies with many service members and 44% of studies with all service members achieved ≥85% of the anticipated enrollment (p = 0.600). In comparing the many and all service member subgroups, significant differences were found in the median values for anticipated enrollment and actual enrollment, even when accounting for Bonferroni correction. Evaluations of mean values did not show a statistical difference between the military subgroups. There were no significant differences according to study sponsor (military, academic, Veterans Affairs, National Institutes of Health, nonprofit organization, or industry) for a study achieving or not achieving ≥85% of the anticipated enrollment. This review supports anecdotal reports of difficulty recruiting service members as research participants. However, the findings also indicate that in many regards, there is not much difference in the difficulties recruiting service members versus other research participants. Findings suggest that it is often difficult to recruit research participants regardless of the specific population or type of study sponsor, and that studies with either many or all service member participants have similar achievement of recruitment goals. Findings in this study may be useful for those who design research that includes service members or for those who are apprehensive about including service members in their research.

Abstract P3-10-02: Increasing participation in research - breast cancer (Inspire-BrC)

Abstract Background: Increasing Black patients' participation in cancer clinical trials is important because of the population's lower survival rate. Accrual for Blacks is the lowest of all groups at 0.5-1.5%. Our study aims to increase trial participation rates among Black breast cancer patients by testing the effectiveness of a culturally tailored video intervention on the decision to participate in a clinical trial. Methods: We hypothesized that the intervention would increase clinical trial enrollment by 6 percentage points compared to our 2012 enrollment baseline of 6% (22/384). Self- identified Black patients with invasive breast cancer at 5 MedStar Hospitals watched a 15' video about clinical trials, targeting six cultural and attitudinal barriers to participation. The Attitudes and Intention to Enroll in therapeutic clinical Trials (AIET) pre-/post-/follow-up tests with 31 items was used to determine the impact of the video on three domains: actual trial enrollment; likely participation in trials; and attitudes toward trials. The pre-test was conducted at baseline; post-test immediately after video; and follow-up 7-21 days after the intervention. Participants were followed for 6 months to assess trial enrollment status. Descriptive statistics were used to describe study subjects with respect to basic characteristics; means and standard deviations for continuous variables; and frequencies and percentages for categorical variables. Repeated measures analysis of variance was used to examine whether the changes in attitudinal barriers were statistically significant over time. The primary outcome measure was the proportion of Black breast cancer patients who signed consent and/or enrolled in a therapeutic clinical trial. Results: From Mar/2014 to Sept/2015, 279 patients were approached to join INSPIRE-BrC prior to discussion about therapeutic clinical trials; 52 declined participation. 208 signed consent and 200 completed it. Average age was 59 yrs (SD=12), 75% were stage I-III; 29% were married; 85% had 1 or more children; 29% attended some college or technical school; 53% had private insurance, 31% Medicare, 16% Medicaid; and 53% had a household income &amp;lt;$40,000/yr. A total of 41 INSPIRE-BrC participants (20.5%) signed consent and 29 (14.5%) enrolled onto a therapeutic study (one-sided p=0.027 vs H0: P=0.06). Pre-video, 52% of patients expressed that it was likely they would participate in a hypothetical therapeutic clinical trial; immediately post-video, 67% (p=&amp;lt;0.001) and 7-21 days after the intervention, 64% (p=0.003). Among 31 AIET items, 25 (81%) showed statistically significant and positive change after the intervention. Specifically, trust in the doctor increased and, suspicion in trials decreased (p&amp;lt;0.001). Further, patient views on fairness for treatment of poor people and Blacks became significantly more positive (p&amp;lt;0.001). Conclusion: Study findings show that the video is a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among Black cancer patients. The video also has the potential to positively change attitudes about clinical trial participation. The study was supported by the Breast Cancer Research Foundation. Citation Format: Swain S, Robinson BN, Newman AF, Tefera E, Herbolsheimer P, Nunes R, Gallagher C, Randolph-Jackson P, Omogbehin A, Dilawari A, Pohlmann P, Mohebtash M, Ottaviano Y, Mohapatra A, Lynce F, Mete M. Increasing participation in research - breast cancer (Inspire-BrC) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-10-02.

Lessons from a Broad-based ACA Outreach Effort: Promises and Pitfalls.

The Marketplace Coverage Initiative (MCI) sought to expand awareness and ACA Marketplace enrollment in the greater Kansas City Area. The MCI was evaluated through interviews, surveys, and focus groups. Two main findings are particularly relevant for future Marketplace enrollment efforts. First, the link between contacting someone and actual enrollment is tenuous as follow-up is challenging. Outreach efforts that only track contacts, such as appointments and email addresses, lack information needed to assess enrollment. Linking outreach activities to enrollment outcomes leads us to a dramatically different conclusion about using big data and campaign-style tactics than evaluations of similar techniques such as that pioneered by Enroll America in 11 states. Second, there is a large chasm between the knowledge levels of the uninsured and the decisions they face on the Marketplace. Based on these findings, outreach efforts were redesigned for the 2014 open enrollment period to focus on smaller, community-driven projects.

The Dynamics of Study-Work Choice and its Effect on Intended and Actual University Attainment

We study the dynamics of study-work choices of Australian high school students and how these choices affect intended and actual enrolment in universities when they finish their school education. A dynamic random effect multi-equation model is constructed and estimated. We find that study-work choices are state dependent, driven by student heterogeneity and the school environment they are in. They are also related to behaviours of the fellow students in the same school. We find that study-work choices significantly affect enrolment in universities but they hardly have any effect on students' preference for university attainment.

Actual enrollment situation in Bay Islands of Honduras

Actual enrollment situation in Bay Islands of Honduras

Unexpected Co-Benefits: Forest Connectivity and Property Tax Incentives

Forest property tax incentives were developed in the early 1900s to enhance onsite forest management and ensure predictable timber supplies, but their ongoing contributions to landscape connectivity between public and private forests are not well understood. We measured spatial connectivity between public forests and private forests enrolled in forest tax programs. We also analyzed tax program laws and agency policies to determine whether the design or implementation of the programs considered connections to public lands. We focused on one of the largest forest tax incentive programs in the United States: Wisconsin’s Managed Forest Law and Forest Crop Law, which enrolled 1.1 million ha of the state’s privately owned forests. We quantified patch density, mean patch size, and area-weighted mean patch size of enrolled forests in three ecologically distinct regions. A neutral landscape model analysis showed that actual enrollments were more likely to cluster near public lands than enrollments randomly distributed across the forested landscape. Yet the tax programs’ statutes and policies revealed no consideration of public lands in the programs’ planning or implementation. Although they are a voluntary, untargeted policy tool, forest tax programs provide the unintended but important benefit of connectivity with public lands. If states and stakeholders recognize forest tax programs as a means to achieve landscape planning goals, they could coordinate cross-boundary management efforts and target areas of particular conservation interest. Forest tax programs deserve greater attention as a private land conservation strategy.

Empowering Latino Parents to Transform the Education of Their Children

This article emphasizes the role of parental involvement in the college preparation of Latino elementary and secondary school students. Although literature shows that education is highly valued in Latino families, actual college enrollment rates for Latino youth are below average. This has been attributed to barriers including lack of financial resources, problems in communication with schools, and low familiarity with the college planning process. The American Dream Academy is a university outreach program that is designed to help Latino families overcome these barriers. We conducted a qualitative analysis of speeches that were prepared and delivered by parents at graduation ceremonies of the program from 2007 to 2009. Our analysis revealed six themes: facing challenges, envisioning success, understanding the school system, taking ownership, community raising a child, and creating a supportive home environment. The findings enrich existing literature and help understand the complex systems that are at play with parental involvement in Latino families.

How University Websites’ Emphasis on Age Diversity Influences Prospective Students’ Perception of Person-Organization Fit and Student Recruitment

Despite of the popularity of emphasizing diversity information on university websites surprisingly little is known about if how and why diversity recruitment strategies actually affect students’ enrollment decisions. To gain insight into this question this paper introduces and tests a model applying general social psychological theorizing to the relationships that older university applicants may form with a potential future university. Study 1 (N = 172), a web-based scenario experiment, confirmed the model’s assumption that emphasizing diversity in terms of students’ age increases perceived person-organization fit through consolidating anticipation of organization-based respect and pride. Study 2 (N = 195), a naturalistic field study among actual university applicants, replicated this mediational model. Importantly, including alternative predictors of applicants’ enrollment decisions in the model (e.g., personal goals for studying) did not change this picture. An additional follow-up after 3 months (N = 62) also secured evidence for the proposed model’s predictive power with regard to participants’ actual enrollment. Practical and theoretical implications of these findings for university recruitment strategies are discussed.

Why Do Students Leave Education Early? Theory and Evidence on High School Dropout Rates

This paper contributes to the growing literature on school dropout by proposing and empirically testing a theoretical framework on the enrollment decision of youngsters in secondary education. The model relates school dropout to time preferences, motivation, opportunity costs and policy measures. It is empirically tested on longitudinal data of about 4000 Dutch vocational students. We evaluate the enrollment decision of students for (i) different intensity levels of dropout prevention policy, and for (ii) different levels of economic development. The results indicate that the model can accurately predict actual enrollment rates over the period 2000–2013. Copyright © 2016 John Wiley &amp; Sons, Ltd.

Abstract OT3-03-01: Increasing participation in research - Breast cancer

Abstract PURPOSE: Increasing Black patients' participation in cancer clinical trials is particularly important because of the population's lower survival rate. Accrual to clinical trials remains low among the general population (1-3%), with recruitment of Blacks the lowest of all groups at 0.5-1.5%. INSPIRE-BrC aims to increase trial participation rates among Black breast cancer patients and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. METHODS: The study was approved by the Institutional Review Board at all sites and opened in March 16, 2014. Black breast cancer patients at five MedStar sites will view a 15 minute, culturally-tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. A pre-test/post-test method is used to determine the impact of the video on three variables -- likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the 6 barriers); and actual trial enrollment. Participants are followed for six months after participating in the intervention to assess clinical trial enrollment status. ELIGIBILITY CRITERIA: The study includes patients with invasive breast cancer, who are Black or African American and have never participated in a therapeutic clinical trial. Participants can be male or female and must be 18 years or older. EXPECTED FINDINGS: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for Black breast cancer patients in five MedStar hospitals. The primary outcome measure is the proportion of Black breast cancer patients who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among Black cancer patients. STATISTICAL METHODS: Bivariate associations between enrollment status and patient-level characteristics will be examined by t-tests for continuous variables and chi-square tests for categorical variables. Paired t-tests and McNemar's test for paired proportions will be used to measure the changes in attitudes and beliefs, measured based on pre-post test. Multiple logistic regression models will be used to predict enrollment status including many factors identified in the literature as predictors, which are, but not limited to age, gender, SES, insurance status, and stage. ACCRUAL: As of June 2, 2015, the total accrual across all five sites is 177 patients. INSPIRE enrollments as of June 2, 2015MedStar Franklin Square Medical Center10MedStar Georgetown University Hospital16MedStar Harbor Hospital12MedStar Union Memorial Hospital19MedStar Washington Hospital Center120Total177 The accrual goal is 200 patients. We anticipate meeting this goal in July 2015, and analyzing the data in January 2016. CONTACT: Brandi N. Robinson, MPH Program Manager Oncology Research MedStar Health Research Institute Washington Cancer Institute at MedStar Washington Hospital Center 110 Irving Street, NW, Room C-2149, Washington, DC 20010 Phone: (202) 877-3058 |Fax: (202) 877-4072 Brandi.n.robinson@medstar.net Citation Format: Robinson BN, Swain SM. Increasing participation in research - Breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-03-01.

A Novel Hybrid Fuzzy Time Series Approach with Applications to Enrollments and Car Road Accidents

Fuzzy time series techniques are more suitable than traditional time series techniques in forecasting problems with linguistic values. Two shortcomings of existing fuzzy time series forecasting techniques are they lack persuasiveness in dealing with recurrent number of fuzzy relationships and assigning weights to elements of fuzzy rules in the defuzzification process. In this paper, a novel fuzzy time series technique based on fuzzy C-means clustering and particle swarm optimization is proposed to resolve these shortcomings. Fuzzy C-means clustering is adopted in the fuzzification process to objectively partition the universe of discourse. Then, particle swarm optimization is adopted to assign optimal weights to elements of fuzzy rules. Actual yearly enrollments at the University of Alabama and yearly deaths in car road accidents in Belgium are used as benchmark data. The forecasting results showed that the proposed method outperformed other existing methods. General Terms Fuzzy Systems, Pattern Recognition, Evolutionary Algorithms

Abstract A18: Increasing Participation in Research - Breast Cancer

Abstract Increasing Participation in Research – Breast Cancer (INSPIRE-BrC) aims to increase therapeutic clinical trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. The study was opened in mid-March of 2014. Increasing black patients' participation in cancer clinical trials is particularly important because of the population's lower survival rate. Accrual to clinical trials remains low among the general population (1 to 3%), with recruitment of blacks the lowest of all groups at 0.5 to 1.5%. Clinical trials are key to developing new methods to prevent, detect, and treat cancer. Methods: INSPIRE-BrC is a prospective nonrandomized clinical trial. A sample size of 123 black patients with breast cancer at five MedStar sites (two in the District of Columbia and three in the Baltimore area) will view a 15 minute, culturally tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. The six cultural and attitudinal barriers to participation that have been documented in literature and verified by the MedStar Washington Hospital Center, Washington Cancer Institute experience are: 1) Fear and distrust of the medical establishment (doctors, scientists and the government); 2) Concern about the ethical conduct of investigators (e.g., Tuskegee Syphilis Study); 3) Fear of losing one's rights by signing a research informed consent document ; 4) Worry that investigators will treat poor or minority patients unfairly (e.g., the patient becomes a guinea pig); 5) Loss of privacy; and 6) Lack of knowledge and awareness of clinical trials (e.g., what would be done, what would be expected from them and what are the expected risks and benefits of the research presented at participant's comprehension level). A pre-test/post-test method is used to determine the impact of the video on three variables — likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the six barriers); and actual trial enrollment. We will use the Attitudes and Intention to Enroll in therapeutic clinical Trials (AIET) questionnaire in which items were all adapted from existing scales that measured concepts similar to those assessed in this study. Each of six attitudinal barriers measured represent a subscale on the AIET consisting of five items, each assessed on a 5-point Likert-type scale. Responses are scored 1=Strongly Disagree; 2=Somewhat Disagree; 3=Not sure/Neither; 4=Somewhat Agree; 5=Strongly Agree. Expected Findings: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for black patients with breast cancer in five MedStar hospitals. The primary outcome measure is the proportion of black patients with breast cancer who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among black patients with cancer. INSPIRE- BrC Enrollment as of July 28, 2014 MedStar Franklin Square Medical Center - 5 MedStar Georgetown University Hospital - 6 MedStar Harbor Hospital -7 MedStar Union Memorial Hospital - 7 MedStar Washington Hospital Center - 40 Total - 65 Citation Format: Brandi N. Robinson, Sandra M. Swain. Increasing Participation in Research - Breast Cancer. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A18.

Predicting Enrollment of New Criminal Justice Doctoral Programs

The study reports the results of an attempt to predict enrollment for a newly proposed doctoral program in criminology/criminal justice. The methodology used to create the enrollment projection was a differential equation utilizing a combination of survey data and existing archival data. The study compares the projection results to the first five years of actual enrollment in the program to validate the projection. While the enrollment projection was somewhat off in the first two years, in years three through five the projection was very successful. While this study focuses on a specific program, the methodology was successful and should be applicable to predicting enrollment in a wide range of programs where preexisting populations are not available to form a projection base.

Kick it like Özil? Decomposing the Native-Migrant Education Gap

We investigate second-generation migrants and native children at several stages in the German education system to analyze the determinants of the persistent native–migrant gap. In particular, if migrant and native children shared the same socioeconomic family background, would we still observe differences in education outcomes? Applying linear and matching decomposition methods to carefully account for differences in background characteristics, we find no disparities in recommendations for and actual enrollment at secondary school types between migrant children and comparable native peers. Also, the native–migrant education gap at the age of 17 years can be entirely explained by differences in socioeconomic family background. We thus conclude that comparable natives face similar difficulties as migrant children in the German education system. There are more general inequalities in secondary schooling that are not migrant specific, but related to socioeconomic family background.

Choices, Choices: Determining Significant Predictors of Choosing a School and Choosing Charters in Denver's Universal School Enrollment Program

Through charter school laws, more than 40 states now enable parents to send their child to a school other than their neighborhood school. Given the option, what kinds of schools do parents prefer -- charter or traditional public schools? Are there differences in preferences based on family and student performance characteristics? To answer these questions, a body of literature has examined enrollment patterns, but for various reasons of policy and practice, enrollment patterns are not necessarily accurate representations of parental preferences. This study takes advantage of a rare centralized enrollment system in Denver, Colorado, that enabled the authors to track the actual stated choices/preferences of parents. Results indicate the most consistent predictor of affirmatively choosing a school and choosing a charter school is race/ethnicity. In particular, black families are almost always more likely than White families to choose and to choose charters. The same is also usually true for Hispanic families. Beyond race/ethnicity, few other variables demonstrate consistent patterns of relationships or significance across dependent measures or grades. ELL students, those with IEPs, and students who quality for free or reduced lunch sometimes choose or choose charters at significantly greater or lesser rates, but not consistently so. Finally, actual prior academic performance and prior enrollment in a charter school appear to play only a trivial role in predicting whether parents choose or choose charters.

Culturally Competent Strategies for Recruitment and Retention of African American Populations into Clinical Trials.

To identify successful recruitment strategies, challenges and best practices for researchers to engage African American communities in clinical studies taken into consideration target participants' culture and context. We reviewed 50 studies conducted from 2001 to 2012 at an inner-city research center to determine the type, duration, anticipated enrollments and actual enrollments. Survey was sent to study coordinators to obtain data on recruitment and retention strategies, challenges and dropout rates. We also interviewed 25 study coordinators on challenges and strategies. Of the 50 studies, 24 had completed recruitment at the time of this report. The completed studies achieved a median recruitment rate of 88% (range: 50-110). Successful recruitment and retention strategies included: field-based strategy and snowballing. Major barriers were: distrust, compensation, education disadvantage, lack of interest, and inability to have study partner. Strategies to reduce barriers included providing informational sessions, disseminating newsletters about study outcomes. Best practices include being culturally sensitive including demonstrating a caring attitude and being responsive to participants needs. Cultural competence is critical in order to design and implement successful recruitment strategies in this population. Research teams should consist of multiethnic staff, involve the community, demonstrate trust and deliver concise education of the research endeavor.

Importance of Contract Attributes on Conservation Reserve Program Enrollment Decisions in the Prairie Pothole Region

U.S. farmers? interest in CRP has waned. Enrollment for 2015 was targeted at 26 million acres but as of the end of February, actual enrollment had declined to 24.6 million acres (USDA, 2015). Available studies point to recent fluctuations in commodity prices as a predominant factor in this enrollment gap. Other potentially influencing factors remain understudied, including farmer preferences for contract design. A choice experiment survey was conducted in the Prairie Pothole region to assess these preferences. An exploded logit model was used to evaluate the preference heterogeneity among program attributes. Results indicate that an increase in the maximum payment, length of contract, and the government?s share of establishment cost increase the utility of farmers, whereas, fixing terms at the beginning of the contract and imposing more land use restrictions on enrolled land have a negative impact on farmers? utilities.

Mismatch of available cancer therapeutic trials to patient populations in community practices.

84 Background: Clinical cancer research has consistently been associated with improvements in the quality of cancer care in community practices. We initiated a project to better identify the barriers to enrollment into adult oncology therapeutic trials in a community setting. Methods: Over a 12-month period from June 2013 – May 2014, all consecutive new patients presenting to medical oncologists at two community practices (CP1 and CP2) affiliated with an NCI-designated Comprehensive Cancer Center (NCI CCC) were screened by trained clinical research nurses. Data captured included demographics, diagnoses, stage of disease, previous treatments. Therapeutic trials available through the NCI CCC were matched to the patients. Actual enrollments rates into the trials were calculated. Results: A total of 1,430 new patients was seen in the time period studied (CP1, n=1,088; CP2, n=342). Of these, 912 (CP1, n = 667; CP2, n = 245) patients had a cancer diagnosis. At CP1, 63 therapeutic trials were available through the NCI CCC. 64 (8.3%) patients matched the criteria for any of the available trials, 33 enrolled, 18 declined, 13 failed screening. The accrual rate was 51.5% (33/64) of the patients who matched available trials and 4.9% (33/667) of all new cancer patients. At CP2, 32 (13%) patients matched available trials. The factors associated with the inability to match therapeutic trials with the new patients included: adjuvant treatment status, disease sites, prior treatment requirements, protocol specific tests, protocol specific requirements for correlative studies. Conclusions: Of the 912 new cancer patients treated at 2 community sites affiliated with an NCI CCC, only 10.5% matched available therapeutic trials. Although the enrollment rate into therapeutic trials is high in patients who matched available trials (51.5%), the overall accrual rate of all new cancer patients is 4.9% and consistent with previous studies. Our study highlights the significant mismatch between available trials and clinical populations treated at community sites. We suggest that an improved process to better match patient populations and available trials will improve on clinical trial accruals and efficiencies.

Increasing participation in breast cancer research: (INSPIRE-BrC).

53 Background: Increasing black patients’ participation in cancer clinical trials is particularly important because of the population’s lower survival rate. Accrual to clinical trials remains low among the general population (1 to 3%), with recruitment of blacks the lowest of all groups at 0.5 to 1.5%. Clinical trials are key to developing new methods to prevent, detect, and treat cancer. INSPIRE-BrC aims to increase trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. Methods: A sample size of 123 black patients with breast cancer at five MedStar sites will view a 15 minute, culturally tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. A pre-test/post-test method is used to determine the impact of the video on three variables — likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the 6 barriers); and actual trial enrollment. Expected Findings: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for black patients with breast cancer in five MedStar hospitals. The primary outcome measure is the proportion of black patients with breast cancer who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among black patients with cancer. [Table: see text]

Variability in IRBs regarding parental acceptance of passive consent.

Passive, opt-out recruitment strategies have the potential to improve efficiency and enlarge the participant pool for clinical studies. We report on the feasibility of using a passive consent strategy for a multicenter pediatric study. We assessed the response to passive and active control recruitment strategies used in a multicenter pediatric cohort study and describe the variability in acceptance among institutional review boards (IRBs) and parents of pediatric patients. Twenty-six pediatric centers submitted IRB applications; 24 centers participated. Sixteen IRBs approved the proposed passive recruitment strategy, and 6 IRBs required active consent strategies; 2 centers used a modified participation mode using control subjects from neighboring centers. In all, 4529 potential participants were identified across 22 centers. In the pre-enrollment phase, opt-out rates were significantly lower in the passive consent group compared with the active recruitment centers (1.6% vs. 11.8%; P < .001). During the enrollment phase, however, refusal rates in the passive consent group were significantly higher (38.1% vs. 12.2%; P = .004). The overall refusal rate across both groups was 33.3%. IRB variability in interpretation and application of regulations affects consistency of study procedure across sites and may reduce validity of study findings. Opt-out consent allowed us to create a large representative pool of control subjects. Parents were more likely to refuse to be approached for a study in the pre-enrollment phase when active consent was used, but were more likely to decline actual study enrollment when passive consent was used in the pre-enrollment period.