Objectives

Data sharing and data transparency are becoming the new standard in pharmaceutical and medical device science. The YODA Project provides a means for rigorous and objective evaluation of clinical trial data to ensure that patients and physicians possess all necessary information about a drug or device when making treatment decisions. This process includes making participant-level clinical research data available for analysis by external investigators. The project is designed to provide partners with confidence that the analyses will be scientifically rigorous, objective, and fair. The YODA Project is guided by the following core principles, which reflect the overall mission of the project to promote open science by:

Promoting the sharing of clinical research data to advance science and improve public health and healthcare
Promoting the responsible conduct of research
Ensuring good stewardship of clinical research data
Protecting the rights of research participants

Background

The YODA Project is an effort by a group of academically-based clinical researchers to facilitate access to participant-level clinical research data and/or comprehensive reports of clinical research, such as full Clinical Study Reports [CSRs], with the aim of promoting scientific research that may advance science or lead to improvements in individual and public health and healthcare delivery. The YODA Project has served as a trusted third party in a variety of collaborative efforts to make scientific data more broadly available to researchers for the betterment of patients, scientific research, and society. Ongoing projects include conducting independent reviews of requests for access to pharmaceutical and medical device company data that could enable new scientific discoveries. As the expectation for open science and research transparency expands, the YODA Project continues to evolve as a leader in responsible data access while maintaining the touchstone of its core values. The YODA Project approach to data sharing is unique in the following ways:

The YODA Project is an independent, academic, third party without interest in the data, removing the perception of influence over access
Data sharing partners have given the YODA Project full jurisdiction to make decisions regarding data access
The YODA Project reviews requests and associated registration materials to ensure that all required information is completely submitted, and is committed to facilitating external access to these data for scientific purposes

The YODA Project is currently partnering with the following Data Holders to facilitate access to their clinical trial data: Johnson & Johnson and SI-BONE. For SI-BONE, 2 clinical trials of the iFuse Implant System® are available, whereas for Johnson & Johnson, a wide range of clinical trials for pharmaceutical and medical device products are being made available. The supporting documentation available for each trial are listed on the trial's individual page and may include any or all of the following: collected datasets, annotated case report forms (CRFs), data definition specifications, protocols with amendments, analysis datasets, statistical analysis plans, and clinical study reports (CSRs). See the YODA Project website for more details. In addition, the publications resulting from use of data accessed through the YODA Project are listed below.

Publications

Storgaard H, Gluud LL, Bennett C, Grøndahl MF, Christensen MB, Knop FK, Vilsbøll T. Benefits and Harms of Sodium-Glucose Co-Transporter 2 Inhibitors in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis. PLoS One. 2016;11:e0166125. PMID: 27835680

Mospan GM, Wargo KA. 5-Day versus 10-Day Course of Fluoroquinolones in Outpatient Males with a Urinary Tract Infection (UTI). JABFM. 2016;6:654-662. PMID: N/A

Laurie AL, Chen Y, Chou R, Fu R. Meta-Analysis of the Impact of Patient Characteristics on Estimates of Effectiveness and Harms of Recombinant Human Bone Morphogenetic Protein-2 in Lumbar Spinal Fusion. Spine. 2016;41:E1115-1123. PMID: 27031772

Noshchenko A, Lindley EM, Burger EL, Cain CM, Patel, VV. What Is the Clinical Relevance of Radiographic Nonunion After Single-Level Lumbar Interbody Arthrodesis in Degenerative Disc Disease?: A Meta-Analysis of the YODA Project Database. Spine. 2016;41:9-17. PMID: 26274529

Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, Helfand M. Effectiveness and Harms of Recombinant Human Bone Morphogenetic Protein-2 in Spine Fusion: A Systematic Review and Meta-analysis. Ann Intern Med. 2013;158:890-902. PMID: 23778906

Simmonds MC, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Rodgers MA, Stewart LA. Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data. Ann Intern Med. 2013;158:877-889. PMID: 23778905