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Innovative Approaches to Promoting Reproducible Research in Clinical Trials

The Immune Tolerance Network (ITN) is dedicated to enhancing the reproducibility and transparency of clinical trials for immune tolerance therapies targeting allergy, asthma, transplantation, and autoimmune diseases. With over 50 Phase I/II trials and significant NIH/NIAID funding, the ITN emphasizes innovation and collaboration through novel assay technologies. Its platform, ITN TrialShare, allows researchers to access data and analyses, fostering an interactive environment for query and alternative analysis. This initiative aims to create a paradigm shift in research publishing, ensuring rigorous methods and best practices.

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Innovative Approaches to Promoting Reproducible Research in Clinical Trials

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  1. ITN TrialShare: Promoting reproducible research and transparency in clinical trialsAdam Asare, PhDDirector, Data Analysis 12/11/2012

  2. Reproducibility of results in published literature Ionnidis, P. et al. Repeatability of published microarray gene expression analyses. Nat Gen , 41:2, Feb 2009

  3. Immune Tolerance Network(ITN) • Clinical trials consortium whose mission is to accelerate the development of immune tolerance therapies • Therapeutic areas include: allergy/asthma, transplantation, and autoimmune diseases • Over 50 Phase I/II clinical trials • NIH/NIAID funded for over 12 years, ~30M/year • Numerous academic and industry partners • Core objectives: Innovation & Collaboration • Develop novel assay technologies • Support rigorous and reproducible research • Adhere to standardized platforms and processes • Use best practices approach to statistical methodology • Disseminate data and results to research community

  4. Web access to data and analyses: itntrialshare.org

  5. Data analysis study archive

  6. Manuscript figures and analysis code console Original Analysis Data User-defined analysis figure and output Code Download data and code base Re-run analysis within system

  7. Create a new paradigm for research publishing • Generate high-profile manuscripts that are interactive at the data and code level • Query for information regarding how the published data was generated • Allow exploration of alternative analysis approaches • Benefits realized • Allows rapid review of data and analysis approaches by study team internally for manuscript development • Public resource available to the research community for reference datasets and analysis approaches • Expect additional functionality to be phased in over time

  8. Funding Attribution Slide: General ITN FUNDED BY: National Institute of Allergy & Infectious Diseases FoodAllergy Initiative National Institute of Diabetes & Digestive & Kidney Diseases

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