How clinical data use benefits from academic-industry partnerships

As the use of electronic clinical data in care delivery increases, so, too, will carefully considered collaborations by academic institutions and health industry players, according to a recently published viewpoint in the Journal of the American Medical Association. And despite skeptics' concerns about compromised results due to potentially distorted data, ensuring industry involvement in such efforts is not only beneficial to both sides, but also should be considered necessary, the authors say.

"As the focus on novel uses of data in healthcare intensifies, there will be an increasing need for academic-industry relationships that maximize the benefits achieved from appropriately using these data," write the authors, who represent Harvard Medical School, the Boston Veterans Affairs Medical Center, the Regenstrief Institute, Indiana University School of Medicine and Merck. "Neither industry nor academia can navigate this terrain alone--nor should they."

According to the authors, such partnerships are mutually beneficial in that they provide researchers with steady financial backing for their systems and efforts, while industry stakeholder--such as pharmaceutical and device companies--are able to continually monitor use of their products. "Evaluations of electronic clinical data could enable the study of products in patients whose lives and conditions often differ from patients enrolled in the clinical trials that first demonstrated the product's use," the authors say.

The authors specifically talk about a partnership formed in 2012 between Regenstrief and Merck that, to date, has launched more than 50 projects that rely on data from more than 11 million patients. Data for all projects, the authors say, is de-identified, with only Regenstrief researchers able to access such information; all others involved only have access to aggregate results.

"Regenstrief maintains a data core composed of trained data analysts who serve as a firewall between the data and Merck and Regenstrief investigators," the authors say. "Individual-level data, even de-identified, do not pass to the industry partner. This 'arm's-length' arrangement is critical for preserving the institutional and patient trust."

Federal officials believe industry participation in all aspects of the lifecycle of health IT products to be important. In the U.S. Department of Health & Human Services' recently proposed risk-based regulatory framework for health IT, for instance, the Office of the National Coordinator for Health IT and IT developers are called upon to provide feedback with regard to safety.

"Thinking about health IT, and safety in particular, requires consideration of not just the developers, but also how products are used, how they're implemented [and] how they're integrated with other products," Jodi Daniel, director of ONC's office of policy and planning, said following the framework's release last week. "It really is a complex, sociotechnical system. If we want to focus on safety, we have to focus on all of the different players."

To learn more:
- here's the JAMA viewpoint

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