? CLINICAL RESEARCH DESIGN, EPIDEMIOLOGY AND BIOSTATISTICS CORE Use of robust study design with modern statistical and epidemiologic methods plays an essential role in integrated, multidisciplinary research teams created to optimize the pathway from the development of new treatments, techniques and devices in the laboratory to their application for improved diagnosis, treatment, and prevention of disease of patients. We propose to develop the Clinical Research Design, Epidemiology, and Biostatistics Key Component of the RI-CCTS to provide expertise and resources to facilitate research across institutional boundaries that will increase the capacity, sophistication, and application of contemporary analytical approaches to transform clinical and translational research in Rhode Island. The Key Component will connect strong but isolated research units scattered throughout Brown University Alpert Medical School and its seven affiliated hospitals, Brown School of Public Health and University of Rhode Island College of Pharmacy. Current collaboration among these entities has relied on ad hoc analytic teams that do not interface and study design mentoring with no unified core. As a result, methods expertise has failed to reach a broad clinical audience, existing teams have not benefited from others' experience and new methods and tools are not widely distributed.
We aim to create a central ?storefront? through which investigators could access all of the research tools available throughout the state and research training from its renowned academic affiliates. In order to develop this program, we propose the following three Specific Aims:
Specific Aim 1 : Services & Resources: Develop an easily accessible multidisciplinary, integrated center that provides support to clinical and translational investigators in study design as well as collection, management, analysis, interpretation and presentation of data using procedures that ensure quality control and reproducibility of all analyses Specific Aim 2: Education &
Develop and offer training materials in study design, epidemiology and biostatistics for early and mid-career investigators as well as provide training in statistical collaboration and consultation for core statistical staff and student consultants Specific Aim 3: Tools & Method Development: Provide a supportive environment to enable clinical investigators and statistical analysts to develop, validate and disseminate innovative design and analytical methodology arising from clinical and translational research problems The proposed Key Component will transform clinical and translational research in Rhode Island by creating universal access to critical expertise, tools and resources. This access will reach young investigators receiving Pilot Awards and clinicians in isolated environments. It will train young methodologists in research collaboration and provide young and old with a wider range of problems on which to develop and test innovative solutions.
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