August 12, 2016: Sharing Data: Methods to Increase Data Sharing and Improve Human Health
Sharing Data: Methods to Increase Data Sharing and Improve Human Health
Manesh Patel, MD, Director, Interventional Cardiology and Cardiac Catheterization Labs, Duke University Health System
C. Michael Gibson, MD, Beth Israel Deaconess Medical Center, Harvard Medical School
Data sharing; Open science; Clinical trials; Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies (ACCESS); Cardiology; ACCESS-CV; ICMJE
- The underlying mission at all academic organizations includes a culture of scientific curiosity and excellence, and environment of collaboration and teamwork, and a passion for scientific discovery of new knowledge and sharing that knowledge to improve human health.
- The open science movement involves increased access to clinical trial data and mechanisms for data sharing and governance. Several efforts are ongoing such as the Human Genome Project, YODA (Yale Open Data Access), and SOAR (Supporting Open Access for Researchers).
- The International Committee of Medical Journal Editors (ICMJE) issued a proposal in 2016 for the sharing of clinical trial data. As a condition of consideration for publication, the ICMJE proposes to require authors to share with others the deidentified individual-patient data underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.
- A current data-sharing initiative is ACCESS, or Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies. The aim of ACCESS is for academic research organizations to be places that can participate, coordinate, curate, and lead in data sharing. ACCESS CV is a proposal for how to operationalize the sharing of data from cardiovascular clinical trials.
Should trialists begin to routinely add to the informed consent forms the intention of sharing data after the trial ends?
Who gets to determine how secondary data is used?
What about concerns for the privacy of healthcare providers and facilities?
For More Information
Read about the ACCESS CV proposal (2016) in the New England Journal of Medicine: http://www.nejm.org/doi/full/10.1056/NEJMp1605260#t=article.
The National Academies (2015) produced a report on sharing clinical trial data, available here: http://bit.ly/2bmYOoq.
Read the ICMJE proposal (2016) here: http://bit.ly/2aMzO5E.
@CMichaelGibson, @PCTGrandRounds, @Collaboratory1, @PCORnetwork