Who bears the costs for clinical data-sharing?

In the push to boost clinical data-sharing for research, there's little discussion of the costs it entails, according to an article at the Journal of the American Medical Association.

Pushing data out through a file-storage website keeps costs low, but it's of little use for other researchers, say the authors, from Georgetown University and the University of Chicago Booth School of Business.

"In the long run, data sharing is only valuable to the extent that data are organized, accessible and readily usable by others. Understanding and planning for the costs at the outset of research can help realize the full potential of data sharing," they write.

The Alzheimer's Disease Neuroimaging Initiative (ADNI), however, provides a model that offers extensive and timely sharing of data from multiple sources. It's converted to a standardized format and comes with a user-friendly interface and data dictionary.

The article points to four cost categories for this model:

  • Infrastructure costs--this includes not only technology, but also patient consent-management, and legal costs.
  • Standardization--presenting different data sets in a common language, including a data dictionary, plus quality control and ongoing maintenance.
  • Human resources--site investigators and staff, as well as the IT staff make this the largest expense for data sharing.
  • Opportunity costs--the time and effort lost to data-sharing activities that could have been spent conducting new research, generating new data and analyses, and other pursuits.

The researchers who originally collected the data tend to bear the costs, with little cost for secondary users.

"Therefore, cost recovery in data sharing is needed and justifiable, especially because the current funding milieu provides limited support for data sharing," the authors say, suggesting a subscription fee could be one option.

The Institute of Medicine is seeking input on how to share clinical research data more broadly while still protecting the privacy of study participants. How clinical trial data can be shared in a global context is among the key questions under discussion.

An alliance of 70 major research and healthcare organizations from 41 countries plans to address the technical, logistical, and ethical issues in global genomic data sharing.

Researchers, meanwhile, have developed an open-source platform for creating software applications that make complex data understandable and accessible to those without sophisticated informatics expertise.

To learn more:
- find the JAMA article