Abstract
Sharing Data Through the Yale University Open Data Access (YODA) Project: Early Experience
Joseph S. Ross,1,2,3,4 Jessica D. Ritchie,1 Stephen Bamford,5 Jesse A. Berlin,5 Karla Childers,5 Nihar Desai,1,6 Ginger M. Gamble,1 Cary P. Gross,2,3,7 Richard S. Lehman,1,8 Peter Lins,5 Sandra A. Morris,5 Joanne Waldstreicher,5 Harlan M. Krumholz1,3,4,6
Objective
To describe early experience with sharing clinical research data through the Yale University Open Data Access (YODA) Project.
Design
Cross-sectional analysis of all submitted proposals by investigators to use clinical research data being made available by Johnson & Johnson (J & J) through the YODA Project, since the inception of the initiative in October 2014, including approval, data access, and publication status.
Results
Of the clinical trials conducted by J & J, to date, 189 trials have been reviewed by J & J and determined to be available for sharing with external investigators, most commonly of therapies used for the treatment of bipolar disorder and schizophrenia. In addition to 1 medical device trial and 188 pharmaceutical trials, J & J continues to review trials for eligibility, and additional trials can be made available on request, including trials of consumer products. As of June 2017, the YODA Project had received 73 proposals from external investigators to use data from 159 trials; the median number of trials requested was 3 (interquartile range [IQR], 1-9; maximum, 50). Among the 73 proposals, 65 (89.0%) have been approved by an independent review panel and 2 (2.8%) are under review; 6 (8.2%) were withdrawn or closed owing to patient privacy concerns, unavailability of needed data elements, or lack of research proposal clarity. The most common study purposes proposed were to address secondary research questions (n = 39), combine data as part of larger meta-analyses (n = 35), and/or validate previously published studies (n = 17). Of the 65 approved proposals, 50 researchers have access to the data and are working on their projects (median duration of access, 43.7 weeks; IQR, 21.0-71.5), 8 are awaiting execution of their Data Use Agreement or data preparation, and 5 have completed their projects, 2 of which resulted in publications in the peer-reviewed literature, and 3 of which have submitted a manuscript for publication. In both cases, the final publication represented the originally proposed research. The authors of the remaining 2 proposals did not pursue their projects.
Conclusions
Early experience sharing data through the YODA Project has demonstrated a demand for shared clinical research data as a resource for investigators. As trial funders and investigators increasingly share data, and make use of shared data, it is essential to understand best practices and incentives to ensure success.
1Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, CT, USA, joseph.ross@yale.edu; 2Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; 3Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; 4Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA; 5Johnson & Johnson, New Brunswick, NJ, USA; 6Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; 7Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale Cancer Center and Yale University School of Medicine, New Haven, CT; 8UK Cochrane Center, Oxford, UK
Conflict of Interest Disclosures:
Drs Ross, Desai, Gross, Lehman, and Krumholz and Mss Ritchie and Gamble receive research support from Janssen, the Pharmaceutical Companies of Johnson & Johnson, to develop methods of clinical trial data sharing. Dr Ross and Mss Ritchie and Gamble receive research support from the Blue Cross Blue Shield Association (BCBSA) to better understand medical technology evidence generation. Drs Desai, Ross, and Krumholz receive research support from the Centers for Medicare and Medicaid Services to develop and maintain hospital performance measures that are used for public reporting. Drs Ross and Krumholz and Ms Gamble receive research support from the US Food and Drug Administration (FDA) to develop methods for post-market surveillance of medical devices. Dr Ross and Ms Ritchie receive research support from the FDA to establish the Yale-Mayo Center for Excellence in Regulatory Science and Innovation. Dr Gross receives research funding from 21st Century Oncology and the National Comprehensive Cancer Network–Pfizer. Dr Krumholz chairs a scientific advisory board for United Healthcare. Drs Berlin, Morris, and Waldstreicher, Ms Childers, and Messrs Bamford and Lins are employees of Johnson & Johnson.
Funding/Support:
This research was the direct result of experience gained from a research agreement through Yale University from Johnson & Johnson (Janssen) to develop methods of clinical trial data sharing.
Role of the Funder/Sponsor:
The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the abstract.
Disclaimer:
The authors assume full responsibility for the accuracy and completeness of the ideas presented.