Core-004

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The Research Methods Program is constructed to support with innovative solutions the design, analysis, ethics, and regulatory challenges that face clinical and translational research (CTR) teams in the complex ecosystem in which CTR research is now conducted. The Research Methods Program is comprised of two Cores: 1) the Biostatistics, Epidemiology and Research Design (BERD) core and 2) the Regulatory Knowledge and Support (RKS) core. This program will build upon, share leadership with and collaborate with the corresponding campus-wide infrastructure programs, extending the reach and impact of the CCTSI by leveraging other campus resources to transform our CTR research enterprise. BERD and RKS programs will have co-created activities (Aim 1) that will form a seamless resource for new study design and start-up support for our investigators. The BERD and RKS programs have also identified specific barriers to translation and will develop solutions for removing these barriers, demonstrate the efficacy of these new solutions and disseminate our best practices both within our institution and to the CTSA Consortium (Aims 2-5). The Research Methods goals will be achieved through the following Specific Aims: Aim 1: Develop a multidisciplinary Study Jump-Start Clinic to improve the design and analysis rigor and ensure that ethics and regulatory aspects are responsibly addressed in clinical and translational research. Aim 2: Develop and disseminate new Methodologies for data analysis including development of new software. Aim 3: Develop and promote innovative training and educational resources to encourage rigorous and reproducible designs and analyses in clinical and translational research. Aim 4: Promote an efficient, responsible and safe research environment across the lifespan of each study and facilitate improvements in the research enterprise to promote: Efficiency, Quality, and Ethics. Aim 5: Develop, adapt and disseminate innovative research tools using a regulatory science framework to promote competency. Innovative aspects of this program are an efficient approach to getting investigators together with critical team members prior to submitting a proposal for review, a software development team to enhance analysis methods dissemination, a novel research results dissemination tool kit focused on improving the rate at which study teams provide study results to participants. In addition, BERD and RKS, as our Research Methods Program, will facilitate interactions with the Informatics, Ethics, Community Engagement & Research (CE&R) and TIN Liaison Team to assist investigators in optimal use of these resources. The overall result will be an efficient system to enhance research design and analysis and to accelerate the efficiency of the design-to-implementation phase of the translational research process. Successful completion of the aims will transform the clinical and translational landscape, improve the research rigor, and create innovative solutions to design, analysis and regulatory challenges in clinical and translational research. These outcomes will be measured by the Evaluation Core using the Common Metrics and site specific metrics.