1. ITN TrialShare: Promoting reproducible research and transparency in clinical trials Adam Asare, PhD Director, Data Analysis 12/11/2012

2. Reproducibility of results in published literature 2 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 Download data and code base Re-run analysis within system Original Analysis User-defined analysis figure and output Data Code

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 National Institute of Diabetes & Digestive & Kidney Diseases FUNDED BY: National Institute of Allergy & Infectious Diseases Food Allergy Initiative