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

ITN TrialShare: Promoting reproducible research and transparency in clinical trials

Adam 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

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/yearNumerous academic and industry partners

Core objectives: Innovation & CollaborationDevelop novel assay technologiesSupport rigorous and reproducible researchAdhere to standardized platforms and processesUse best practices approach to statistical methodology Disseminate data and results to research community

Web access to data and analyses: itntrialshare.org

Data analysis study archive

Manuscript figures and analysis code console

Download data and code baseRe-run analysis within system

Original Analysis

User-defined analysis figure and output

Data

Code

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 generatedAllow exploration of alternative analysis approaches

Benefits realizedAllows rapid review of data and analysis approaches by study team internally for manuscript developmentPublic resource available to the research community for reference datasets and analysis approaches

Expect additional functionality to be phased in over time

Funding Attribution Slide: General ITN

National Institute of Diabetes & Digestive & Kidney Diseases

F U N D E D B Y :

National Institute of Allergy & Infectious Diseases

FoodAllergyInitiative