We are developing the novel αIIbβ3 antagonist, RUC-4, for subcutaneously (SC)-administered first-point-of-medical-contact treatment for ST segment elevation myocardial infarction (STEMI).

We studied the (1) pharmacokinetics (PK) of RUC-4 at 1.0, 1.93, and 3.86 mg/kg intravenous (IV), intramuscular (IM), and SC in non-human primates (NHPs); (2) impact of aspirin on RUC-4 IC50 in human platelet-rich plasma (PRP); (3) effect of different anticoagulants on the RUC-4 IC50 in human PRP; and (4) relationship between αIIbβ3 receptor blockade by RUC-4 and inhibition of ADP-induced platelet aggregation.

(1) All doses of RUC-4 were well tolerated, but animals demonstrated variable temporary bruising. IM and SC RUC-4 reached dose-dependent peak levels within 5–15 minutes, with T1/2 s between 0.28 and 0.56 hours. Platelet aggregation studies in NHPs receiving IM RUC-4 demonstrated >80% inhibition of the initial slope of ADP-induced aggregation with all three doses 30 minutes post-dosing, with subsequent dose-dependent loss of inhibition over 4–5 hours. (2) The RUC-4 IC50 for ADP-induced platelet aggregation was unaffected by aspirin treatment (40±9 nM vs 37±5 nM; p = 0.39). (3) The RUC-4 IC50 was significantly higher in PRP prepared from D-phenylalanyl-prolyl-arginyl chloromethyl ketone (PPACK)-anticoagulated blood compared to citrate-anticoagulated blood using either thrombin receptor activating peptide (TRAP) (122±17 vs 66±25 nM; p = 0.05; n = 4) or ADP (102±22 vs 54±13; p<0.001; n = 5). (4) There was a close correspondence between receptor blockade and inhibition of ADP-induced platelet aggregation, with aggregation inhibition beginning with ~40% receptor blockade and becoming nearly complete at >80% receptor blockade.

Based on these results and others, RUC-4 has now progressed to formal preclinical toxicology studies.

There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual’s preparedness to function efficiently in the clinical research enterprise and tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II).

CICRP-II was developed using data collected from clinical research coordinators (CRCs) participating in the “Development, Implementation and Assessment of Novel Training In Domain-Based Competencies” (DIAMOND) project at four clinical and translational science award (CTSA) hubs and partnering institutions.

An exploratory factor analysis (EFA) identified a two-factor structure: the first factor measures self-reported competence to perform Routine clinical research functions (e.g., good clinical practice regulations (GCPs)), while the second factor measures competence to perform Advanced clinical functions (e.g., global regulatory affairs). We demonstrate the between groups validity by comparing CRCs working in different research settings.

The excellent psychometric properties of CICRP-II and its ability to distinguish between experienced CRCs at research-intensive CTSA hubs and CRCs working in less-intensive community-based sites coupled with the simplicity of alternative methods for scoring respondents make it a valuable tool for gauging an individual’s perceived preparedness to function in the role of CRC as well as an equally valuable tool to evaluate the value and effectiveness of clinical research education and training programs.

The National Academies of Sciences (NAS) emphasize the need for interdisciplinary team science (TS) training, but few training resources are available. COALESCE, an open-access tool developed with National Institutes of Health support and located at teamscience.net, is considered a gold standard resource but has not previously been evaluated. COALESCE launched four learning modules in 2011. The Science of TS (SciTS) module, an interactive encyclopedia, introduces foundational concepts. Three scenario-based modules simulate TS challenges in behavioral, clinical, and basic biomedical sciences. This study examined user characteristics, usage patterns, and effects of completing the four modules on TS knowledge, attitudes, and skills.

Repeated measures ANOVA tested for pre-post changes in performance and compared learning by users with biomedical versus other disciplinary backgrounds.

From 2011 through 2017, the site attracted 16,280 new users who engaged in 6461 sessions that lasted more than 1 min. The modal registrant identified as working in a biomedical field (47%), in an academic institution (72%), and expressed greater interest in the practice than the SciTS (67%). Those completing pre- and post-tests (n = 989) showed significant improvement in knowledge, attitudes, and skills after taking all scenario-based modules (p < 0.005); knowledge and attitudes were unchanged after the SciTS encyclopedia. Biomedical and other health professionals improved comparably.

Evaluation of the TS training tool at teamscience.net indicates broad dissemination and positive TS-related outcomes. Site upgrades implemented between 2018 and 2020, including adding five new modules, are expected to increase the robustness and accessibility of the COALESCE training resource.

Asian Americans constitute 5% of the U.S. population. Their willingness to participate in research is important to examine because it influences participation rates and the representativeness of study results.

A total of 17,339 community members participated from six diverse Clinical and Translational Award (CTSA) sites. Community members were asked about their willingness to volunteer for eight different types of health research, their expectation of monetary compensation for research participation, their trust in research and researchers, their preferred language to receive health information, and their socio-demographic background. We examined Asian Americans’ willingness to participate in various types of health research studies and compared their perceptions with other racial/ethnic groups (i.e., Asian n = 485; African-American n = 9516; Hispanic/Latino n = 1889; Caucasian n = 4760; and other minority n = 689).

Compared to all other racial/ethnic groups, Asian Americans were less willing to participate in all eight types of health research. However, Asian Americans reported a lower amount of fair compensation for research participation than African-Americans and Hispanics/Latinos but were as likely to trust researchers as all other racial/ethnic groups.

Asian Americans are less willing to participate in health research than other racial/ethnic groups, and this difference is not due to dissatisfaction with research compensation or lower trust in researchers. Lack of trust in research and language barriers should be addressed to improve representativeness and generalizability of all populations in research.

There are few longitudinal studies about South Asians (SAs) and little information about recruitment and retention approaches for this ethnic group.

We followed 906 SAs enrolled in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) cohort for 5 years. Surviving participants were invited for a second clinical exam from 2015 to 2018. A new wave of participants was recruited during 2017–2018. We assessed the yields from different methods of recruitment and retention.

A total of 759 (83%) completed the second clinical exam, and 258 new participants were enrolled. Providing a nearby community hospital location for the study exam, offering cab/shared ride reimbursement, and conducting home visits were the most effective methods for enhancing retention. New participant recruitment targeted women and individuals with lower socioeconomic status, and we found that participant referrals and active community engagement were most effective. Mailing invitational letters to those identified by electronic health records had very low yield.

Recruitment and retention strategies that address transportation barriers and increase community engagement will help increase the representation of SAs in health research.

Core facilities play crucial roles in carrying out the academic research mission by making available to researchers advanced technologies, facilities, or expertise that are unfeasible for most investigators to obtain on their own. To facilitate translational science through support of core services, the University of California, Los Angeles Clinical and Translational Science Institute (UCLA CTSI) created a Core Voucher program. The underlying premise is that by actively promoting interplay between researchers and core facilities, a dynamic feedback loop could be established that could enhance both groups, the productivity of the former and the relevance of the latter. Our primary goal was to give translational investigators what they need to pursue their immediate projects at hand.

To implement this system across four noncontiguous campuses, open-source web-accessible software applications were created that were scalable and could efficiently administer investigator submissions and subsequent reviews in a multicampus fashion.

In the past five years, we have processed over 1400 applications submitted by over 750 individual faculty members across both clinical and nonclinical departments. In total, 1926 core requests were made in conjunction with 1467 submitted proposals. The top 10 most popular cores accounted for 50% of all requests, and the top half of the most popular cores accounted for 90% of all requests.

Tracking investigator demand provides a unique window into what are the high- and low-priority core services that best support translational research.

Lack of trust toward medical research is a major barrier to research participation, particularly among some population groups. Valid measures of trust are needed to develop appropriate interventions. The study purpose was to compare two previously validated scales that measure trust in biomedical research – one developed by Hall et al. (H-TBR; 2006) and the other by Mainous et al. (M-TBR; 2006) – in relation to socio-demographic variables and attitudes toward research. Differences between Black and White respondents were explored.

Two nearly identical surveys – one with H-TBR and the other with M-TBR – were systematically administered to a convenience sample. Internal consistency reliability of each scale was assessed. Associations were computed between scores on each scale with attitudes toward biomedical research and demographic variables (i.e., gender, age, race, and socioeconomic status). The difference between White and Black respondents on each TBR score while controlling for age, education, and race was also investigated.

A total of 2020 participants completed the H-TBR survey; 1957 completed the M-TBR survey. Mean item scores for M-TBR were higher (F = 56.05, p < 0.001) among Whites than Blacks. Whites also had higher mean item scores than Blacks on H-TBR (F = 7.09, p < 0.001). Both scales showed a strong association with participants’ perceived barriers to research (ps < 0.001) and significant, positive correlations with interest in research participation (ps < 0.001). Age and household income were positive predictors of TBR scores, but the effects of education differed.

Both scales are internally consistent and show associations with attitudes toward research. Whites score higher than Blacks on both TBR scales, even while controlling for age and socioeconomic status.