?Preclinical animal research is critical for driving and setting the conceptual framework for subsequent clinical trials and the establishment of new and novel therapeutic approaches. However, preclinical studies are frequently plagued by weak experimental design, poor randomization procedures, insufficient sample size, arbitrary deletion of apparent outliers and overly simplistic statistical analysis that do not account for potential confounds. These factors have contributed to the less than optimal predictive value of preclinical research. In part these shortcomings are due to insufficient training in experimental design and statistical analysis and the lack of easy accessibility to trained statisticians for guidance. Although statistical packages are commercially available, many are not user-friendly and their use without appropriate knowledge of experimental design and subsequent statistical analysis can be problematic. The goals and objectives of this Phase 1 proposal are to design AniStatTM, a cloud-based service to improve the rigor and reporting of animal studies that will be created to meet the needs of the animal research community. This project involves a new collaboration between individuals with expertise in experimental design, statistical analysis, software development and establishment and use of animal models in biomedical research. Alpha StatConsult biostatisticians, software developers and an animal research collaborator will provide a plan for how AniStatTM could address each item, including cost/time effort, software interface, video tutorials and a user-friendly prototype of the software as a mock-up of the web based interface for each item. These designs will be developed through a Delphi process where stakeholders will provide expert insights on priority capabilities and interactive visualizations fr AniStatTM. A successful outcome of this proposal will be a final prioritized list of software capabilities, schematic prototype of the software to be developed as a Software as a Service (SaaS) model and pilot validation of the software. The SaaS product will be developed, in a Phase II SBIR proposal, to allow animal researchers, with little formal instruction in experimental design and statistics, to use AniStatTM over the internet with pricing based on a monthly fee. The goal is for AniStatTM to help guide and assist scientists to design and report on effective and reproducible animal studies.
Public Health Relevance Statement: Public Health Relevance: The financial and scientific costs of irreproducible animal research are of concern to health-care stakeholders as the resulting lack of progress in health-care innovations and cures will have a long term, negative, impact on public health. The purpose of this Phase 1 effort is to use a collaborative and scientific survey process to design AniStatTM, a user-friendly and readily accessible web interface that will allow researchers to use best practices in animal research design, analysis and reporting. The AniStatTM technology will be designed as a Software as a Service model to provide a user-friendly platform for data analysis and reporting in order increase reproducibility in preclinical animal research.
Project Terms: Accounting; Address; Advocacy; Agreement; Animal Experimentation; Animal Model; Animals; Applications Grants; Automobile Driving; base; Biological Sciences; Biomedical Research; Businesses; Client; Clinical Trials; cloud based; Collaborations; Communities; Computer software; Congresses; cost; Data; Data Analyses; Data Reporting; design; discount; Disease; Drops; Drug Industry; Educational process of instructing; Elements; Ensure; Exclusion; experience; Experimental Designs; Feedback; Fees; Funding Agency; Future; Goals; Guidelines; Healthcare; Imagery; improved; in vivo; Individual; innovation; insight; Instruction; interest; Internet; Journals; Knowledge; knowledge base; Licensing; Longevity; Macaca mulatta; Marketing; meetings; Modeling; Modification; Mus; National Institute of Drug Abuse; novel therapeutic intervention; Oryctolagus cuniculus; Outcome; outreach; Paper; Participant; Phase; Plague; pre-clinical; pre-clinical research; preclinical study; Predictive Value; Price; Procedures; Process; programs; prototype; public health medicine (field); public health relevance; Publishing; Randomized; Rattus; Reporting; Reproducibility; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Sample Size; Scientist; Services; Small Business Innovation Research Grant; software development; software systems; Software Validation; Statistical Data Interpretation; statistics; Structure; Surveys; system architecture; Technology; Time; tool; Training; user-friendly; Validation; web based interface; web interface; web site
