Methodologic Core

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The mission of the CCCR Methodologic Core is – in the COVID era – to accelerate clinical research in musculoskeletal and rheumatic diseases by providing state-of-art expertise to design and develop impactful studies and innovative interventions, and execute rigorous data collection, management, and analysis . While most COVID-19 impacts were negative, many responses have been positive, leading to creative solutions for informed consent, study visits, and use of electronic health record and remote data. In the transition to a new normal, our support of the Research Community specifically addresses vulnerable groups, e.g., early-stage investigators (ESIs) and translational researchers without access to clinical research infrastructure. This Core will support approaches that can be nimble in response to rapid changes and are more resilient than before the pandemic. To advance the next generation of clinical research, we propose to catalyze the work of our Research Community through the following aims: 1) Provide expertise in study design, methodology, outcomes, and statistical analysis planning, a) address elements relevant to all projects (e.g., inclusion, safety, recruitment, assessment, retention, and a priori analysis plan development) and contingency plans in a project specific Virtual Playbook, b) work closely with the Community Advisory Board (CAB) and the Resource Core to help users design research that incorporates patient and other stakeholders' perspectives, c) integrate, as needed, expert input on adaptive/pragmatic study design, epidemiology, behavioral science, nutritional science, economic evaluation, policy analysis, genomics, bioinformatics, and clinical informatics; 2) Facilitate access to and utilization of existing disease-specific databases, registries, and clinical cohorts; 3) Promote safe and responsible data management, a) provide access to database specialists who can advise or lead database construction and serve as a hub to organize institutional resources for database management, b) provide recommendations for data management, addressing complexities involved in combining different data streams (e.g., neighborhood- and individual-level; self-reported and performance-based; data from mobile devices, web-based interfaces, and wearable sensors), c) develop specific data flow plans and complete data management checklists for each project; 4) Assist research teams in completing rigorous statistical analyses that maximize the potential of study data, a) execute statistical analysis plans and collaborate with teams to interpret results, b) support manuscript and grant development, c) refine and apply sophisticated analytic approaches tailored to data that are the focus of the Resource Core; 5) Enhance the methodologic training environment, a) mentor and collaborate to enhance the capabilities ESIs and established investigators, b) provide formal educational activities and events for our Research Community and all CCCRs. This Core will provide a pandemic-responsive infrastructure that supports meaningful and efficient collaboration with CCCR users and their teams, helping to advance clinical research and increase productivity in this new era.