Biostatistics, Epidemiology, and Research Design Core

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Substantial gaps in methodological and statistical support undermine the conduct of scientifically rigorous and culturally responsive clinical and translational research (CTR), especially at the translational Stage T3 to T5. To fill these gaps, the Biostatistics, Epidemiology, and Research Design (BERD) Core will feature seven distinct components: Biostatistics, Epidemiology, Research Design, Data Science, Psychometrics, Mixed Methods, and Economic Analysis. BERD Core’s objective will be to provide resources and strengthen the skills of junior investigators (JI) and established investigators transitioning to CTR in conducting well-designed CTR that reduce the health disparities affecting Indigenous Pacific Peoples (IPP), defined as Native Hawaiians, Other Pacific Islanders, Filipinos, and other medically underserved and vulnerable populations in Hawaii. Specific Aim 1: Provide customized services for the design and analysis of health-disparities CTR by optimizing the use of BERD Core services through leveraging of existing resources and implementing an effective operational plan that recruits appropriate personnel, publicizes resources, and assists users; by assisting investigators in capturing appropriate valid data; by supporting investigators in developing comprehensive, high-quality, unbiased, efficient, reliable, and culturally responsive study designs, including those that address bias in methodology; and by prioritizing support for IPP health-disparities CTR, particularly trials of efficacy (T3) and effectiveness (T4) and adoption and institutionalization (T5). Specific Aim 2: Provide education and training on health-disparities CTR methodologies by mentoring JI/EI in the use of BERD tools and methods appropriate to CTR; by fostering and facilitating environments conducive to career enhancement, emphasizing the preparation and submission of meritorious research proposals by JI/EI, especially those of IPP descent; by designing and promoting an academic- engagement program on research methods and processes; and by creating and promoting a novel outreach program to provide support, mentoring, and education on study design, data analysis, and communication to community partners. Specific Aim 3: Develop tools and methods that maximize the quality of health-disparities CTR by establishing/integrating research designs and biostatistics essential to CTR; by creating design and analysis plans for studies of unique, underserved, or vulnerable populations; by advancing design and analysis plans for studies of small numbers of participants; and developing innovative methods to enhance statistical power. By the end of 5 years, the BERD Core will advance the CTR careers of junior investigators and other transitioning investigators, especially those with IPP backgrounds by supporting their efforts to secure federal funding to conduct independent research aimed at improving the health of IPP and other underserved and vulnerable populations in Hawaii.