The United States has mobilized the full force of its clinical research enterprise to address the Covid-19 pandemic, allocating billions of dollars to support timely research. As of January 2021, for example, the National Institutes of Health (NIH) had issued nearly a thousand awards cumulatively worth roughly $2 billion to support Covid-19 projects ranging from the development of medical products (including diagnostics and vaccines) to evaluations of population-specific risk factors and outcomes.1 Such initiatives, which have yielded new technologies and important evidence, illustrate the value of robust scientific infrastructure.
“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 requested public comments on its draft “Policy for Data Management and Sharing.” In 2018, the International Committee of Medical Journal Editors began requiring data-sharing plans for clinical trials as a condition for publication in member journals. And platforms such as ClinicalStudyDataRequest.com, Project Data Sphere, and BioLINCC 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….
The Yale Open Data Access (YODA) Project, which two of us (J.S.R. and H.M.K.) co-direct, launched in 2011 and formed a partnership with Johnson & Johnson in 2014. This five-year partnership offers an opportunity to reflect on some of the questions about sharing clinical trial data that may inform ongoing and future efforts….”