Opinion: Sharing clinical trial data: lessons from the YODA Project
Sharing data after a clinical trial has been completed seems like it should be a slam dunk, a win for many stakeholders, including the general public. Instead, such data sharing is still something of a hot-button issue, with critics questioning the capabilities and motives of those requesting the data, doubting the utility of replication analyses, and speculating that spurious safety findings would receive unwarranted attention and disrupt patient care.
This week, the National Academies of Science, Engineering, and Medicine are convening the workshop “Sharing Clinical Trial Data: Challenges and a Way Forward” just shy of five years after the Institute of Medicine released its seminal report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.”
During this time, the scientific culture regarding data sharing has shifted. Just last week, the National Institutes of Health on its draft “Policy for Data Management and Sharing.” In 2018, the International Committee of Medical Journal Editors began for clinical trials as a condition for publication in member journals. And platforms such as , , and have emerged or grown. These platforms use a variety of different governance structures and models for data access, developed both with and without the support of industry or government.
