Electronic Health Reporter

A new initiative launched by Health Level Seven International (HL7) seeks to use its widely recognized data exchange standards to help health care researchers more effectively acquire, exchange and use data in translational and clinical research.

The effort, called Vulcan, intends to use a model for collaboration among diverse stakeholders in the translational and clinical research community to define a common set of standards that can be implemented internationally, built on current agreements to use the HL7 Fast Healthcare Interoperability (FHIR) standard to facilitate data exchange.

“Improving data sharing can bring significant benefits to medical research, which is often a time-intensive and costly process that unnecessarily delays progress in discovering treatments for medical conditions because researchers are unable to share critical information,” said HL7 International CEO Charles Jaffe, M.D., Ph.D. “Project Vulcan aims to develop common solutions to help partners overcome these challenges.”

The initiative is the latest to use HL7’s FHIR Accelerator Program, which seeks to expand the FHIR standard and enhance market adoption through a programmatic approach that diverse stakeholders can use. The Accelerator Program aims to motivate and support market collaborations, seeking to speed the availability of FHIR to tackle important interoperability needs. Project Vulcan represents an ambitious new use of the FHIR Accelerator Program, pulling together a diverse multi-stakeholder group that includes government and regulatory agencies, standards development organizations, academic sites, technology vendors and patients.

With the advent of FHIR there is a clear path to utilize FHIR and other existing standards to execute the interoperable exchange of data for clinical research.

“Using FHIR to assist translational and clinical research is a natural extension for the standard,” said Rob Goodwin, co-chair of Vulcan and Vice President of Pfizer’s Global Product Development Operations Center of Excellence.

“Delivering a new therapy to market now takes 10 to 15 years at an average cost of $2.6 billion,” said Goodwin, who’s also on the TransCelerate Clinical Oversight Committee of TransCelerate BioPharma, a non-profit organization that works across the biopharmaceutical research and development community to improve the delivery of new medicines.

“The most powerful way to make research faster and less expensive is to bridge clinical care and clinical research, while keeping patient safety and compliance in mind,” said Amy (Nordo) Cramer, Vulcan co-chair and Pfizer Global Product Development Strategic Partnerships. Cramer continued, “Vulcan’s contributions in using FHIR to streamline data collection and submission, protocol representation, clinical trial setup and management, and for other data-intensive purposes will be a game changer for clinical research.”

Organizers of Vulcan are encouraging other entities to participate in the effort. More information about Vulcan and the project’s goals can be found on its website, www.hl7.org/vulcan.