The Research Centers in Minority Institutions (RCMI) Translational Research Network: Building and Sustaining Capacity for Multi-Site Basic Biomedical, Clinical and Behavioral Research.

The Research Centers in Minority Institutions (RCMI) program was established by the US Congress to support the development of biomedical research infrastructure at minority-serving institutions granting doctoral degrees in the health professions or in a health-related science. RCMI institutions also conduct research on diseases that disproportionately affect racial and ethnic minorities (ie, African Americans/Blacks, American Indians and Alaska Natives, Hispanics, Native Hawaiians and Other Pacific Islanders), those of low socioeconomic status, and rural persons. Quantitative metrics, including the numbers of doctoral science degrees granted to underrepresented students, NIH peer-reviewed research funding, peer-reviewed publications, and numbers of racial and ethnic minorities participating in sponsored research, demonstrate that RCMI grantee institutions have made substantial progress toward the intent of the Congressional legislation, as well as the NIH/NIMHD-linked goals of addressing workforce diversity and health disparities. Despite this progress, nationally, many challenges remain, including persistent disparities in research and career development awards to minority investigators. The continuing underrepresentation of minority investigators in NIH-sponsored research across multiple disease areas is of concern, in the face of unrelenting national health inequities. With the collaborative network support by the RCMI Translational Research Network (RTRN), the RCMI community is uniquely positioned to address these challenges through its community engagement and strategic partnerships with non-RCMI institutions. Funding agencies can play an important role by incentivizing such collaborations, and incorporating metrics for research funding that address underrepresented populations, workforce diversity and health equity.

The Role of Vitamin D and Oxidative Stress in Chronic Kidney Disease.

Chronic kidney disease (CKD) is a major non-communicable disease associated with high rates of premature morbidity and mortality. The prevalence of hypovitaminosis D (deficiency of 25(OH)D or 25D) is greater in racial/ethnic minorities and in patients with CKD than the general population. Low 25D is associated with bone and mineral disorders as well as immune, cardiometabolic and cardiovascular (CV) diseases. Thus, it has been suggested that low 25D contributes to the poor outcomes in patients with CKD. The prevalence of hypovitaminosis D rises progressively with advancing severity of kidney disease with over 30% of patients with CKD stage 3 and 70% patients with CKD stage 5 estimated to have low levels of 25D. This report describes several of the abnormal physiologic and counter-regulatory actions related to low 25D in CKD such as those in oxidative stress and inflammatory systems, and some of the preclinical and clinical evidence, or lack thereof, of normalizing serum 25D levels to improve outcomes in patients with CKD, and especially for the high risk subset of racial/ethnic minorities who suffer from higher rates of advanced CKD and hypovitaminosis D.

User-Friendly Data-Sharing Practices for Fostering Collaboration within a Research Network: Roles of a Vanguard Center for a Community-Based Study.

Although various attempts have been made to build collaborative cultures for data sharing, their effectiveness is still questionable. The Jackson Heart Study (JHS) Vanguard Center (JHSVC) at the NIH-funded Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) Data Coordinating Center (DCC) may be a new concept in that the data are being shared with a research network where a plethora of scientists/researchers are working together to achieve their common goal. This study describes the current practices to share the JHS data through the mechanism of JHSVC. The JHS is the largest single-site cohort study to prospectively investigate the determinants of cardiovascular disease among African-Americans. It has adopted a formal screened access method through a formalized JHSVC mechanism, in which only a qualified scientist(s) can access the data. The role of the DCC was to help RTRN researchers explore hypothesis-driven ideas to enhance the output and impact of JHS data through customized services, such as feasibility tests, data querying, manuscript proposal development and data analyses for publication. DCC has implemented these various programs to facilitate data utility. A total of 300 investigators attended workshops and/or received training booklets. DCC provided two online and five onsite workshops and developed/distributed more than 250 copies of the booklet to help potential data users understand the structure of and access to the data. Information on data use was also provided through the RTRN website. The DCC efforts led to the production of five active manuscript proposals, seven completed publications, 11 presentations and four NIH grant proposals. These outcomes resulted from activities during the first four years; over the last couple of years, there were few new requests. Our study suggested that DCC-customized services enhanced the accessibility of JHS data and their utility by RTRN researchers and helped to achieve the principal goal of JHSVC of scientific productivity. In order to achieve long-term success, the following, but not limited to these, should be addressed in the current data sharing practices: preparation of new promotional strategies in response to changes in technology and users' needs, collaboration with the Network statisticians, harmonization of the JHS data with the other local-based heart datasets to meet the needs of the potential users from the broader geographical areas, adoption of the RTRN comprehensive data-sharing policy to broaden the variety of research topics and implementation of an ongoing monitoring program to evaluate its success.

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

BACKGROUND: New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. METHODS: We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. MAIN OUTCOME MEASURES: The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. RESULTS: Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. CONCLUSION: Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

Importance of capacity assessment for an early staged-research network designed to eliminate health disparity: lessons from RTRN.

BACKGROUND: RCMI Translational Research Network (RTRN) is the first academic-based national network to address the problem of health disparities by integrating minority medical schools in a collaborative effort. While there was a great interest in forming the research network, limited systematic effort has been made in understanding members' existing capacity and future demand. OBJECTIVE: The aim of this study was to report the results of the RTRN Statistical Capacity Assessment and discuss the importance of an initial capacity assessment in building the biostatistical capacity of a research network in its early stage. METHODS: The assessment was based on survey responses submitted by program directors/managers from 12 of the 18 RTRN institutions. In this assessment the capacity is defined as the statistical tools and human resources which are required for effective and efficient performance. RESULTS: A total of 52 biostatisticians (mean of 4.5 per site) were working for 12 RTRN institutions; 84% were fulltime employees, and 53% held a doctoral degree. On average, they had about 13 years of job experience. SAS, SPSS and STATA were the most frequently used and were selected as their major statistical software. A wide inter-institutional variability was found in number of biostatisticians (ranged from 1 to 8), mean years of experience in their position (4.5-20 years) and in major software (5-20), and the number of statistical software in use (1-11). CONCLUSION: The initial capacity assessment provided valuable information on members' background and the network's research capacity which will be used as the basic data in developing programs to build research capacity. Therefore, it is important to include the initial capacity survey and on-going evaluation of network activities when making business plans of research networks intended to reduce health disparities.

Long-term efficacy and safety profile of lanthanum carbonate: results for up to 6 years of treatment.

BACKGROUND/AIMS: Lanthanum carbonate (LC, FOSRENOL) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. METHODS: Patients from four previous trials entered this study. RESULTS: Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium x phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. CONCLUSIONS: LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs.