Website

www.yoda.yale.edu

Description

Abstract

Data sharing and data transparency are becoming the new standard in clinical research to ensure that patients and clinicians possess all necessary information about a drug or device when making treatment decisions. The Yale University Open Data Access (YODA) Project developed a model to facilitate access to participant-level clinical research data to promote independent analysis by external investigators. The YODA Project is currently collaborating with Medtronic, Inc. and Janssen, the pharmaceutical companies of Johnson & Johnson, to facilitate access to their clinical trial program data by external investigators in a manner that is aligned with the following principles: advance science and public health, conduct responsible research, ensure good stewardship of data, and promote transparency. As interest in the release of participant-level data grows, it is critical to carefully consider the approach to releasing data to ensure that the release is executed in a manner that preserves patient confidentiality, facilitates scientific productivity, and respects the values and rights of the participating parties. The YODA Project has identified several key decisions that should be addressed throughout the planning and implementation of the data release process, such as patient confidentiality, data storage, and data use. As varying methods emerge for sharing data, the YODA Project strives to be an innovative leader and to set standards for the field.

Keywords

Data sharing, data release, clinical trial data, participant-level, data storage, data transparency

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The YODA Project: Developing Methods for Sharing Clinical Trial Data

Abstract

Data sharing and data transparency are becoming the new standard in clinical research to ensure that patients and clinicians possess all necessary information about a drug or device when making treatment decisions. The Yale University Open Data Access (YODA) Project developed a model to facilitate access to participant-level clinical research data to promote independent analysis by external investigators. The YODA Project is currently collaborating with Medtronic, Inc. and Janssen, the pharmaceutical companies of Johnson & Johnson, to facilitate access to their clinical trial program data by external investigators in a manner that is aligned with the following principles: advance science and public health, conduct responsible research, ensure good stewardship of data, and promote transparency. As interest in the release of participant-level data grows, it is critical to carefully consider the approach to releasing data to ensure that the release is executed in a manner that preserves patient confidentiality, facilitates scientific productivity, and respects the values and rights of the participating parties. The YODA Project has identified several key decisions that should be addressed throughout the planning and implementation of the data release process, such as patient confidentiality, data storage, and data use. As varying methods emerge for sharing data, the YODA Project strives to be an innovative leader and to set standards for the field.

Keywords

Data sharing, data release, clinical trial data, participant-level, data storage, data transparency

http://elischolar.library.yale.edu/dayofdata/2014/Posters/11