2023-12-white-house_blog-standardize-approach-data-exchange-clinical-trials-meta
Standards & Systems Integration

OpenClinica lauds White House’s commitment to a stronger clinical trial infrastructure

OpenClinica lauds the White House Office of Science and Technology Policy’s (OSTP) commitment to building a stronger clinical trial infrastructure and accelerating clinical trial data capture and the key role the Vulcan Program is playing to standardize approaches to data exchange.

The COVID-19 pandemic revealed an urgent need to improve our clinical trial infrastructure and realize the promise of healthcare interoperability. As a member of Vulcan steering committee and a lead developer of technology to automate source data acquisition from EHRs and EMRs to clinical trial research databases (EDCs), I wholeheartedly welcome the White House’s commitment to this critical initiative.

In an October 26, 2023 blog, the OSTP, as a part of its leadership of a “whole-of-government approach to bolster clinical trial capacity in the United States,” committed to “making clinical trials faster, more inclusive, simpler, and more efficient.”

The OSTP strengthened its commitment to “vetting and piloting more efficient data capture for clinical trials, including by improving and leveraging electronic health records systems, and making data available to researchers more rapidly.”

A number of companies submitted responses to the OSTP’s request for information on data collection for emergency clinical trials and interoperability pilot. OpenClinica, in collaboration with the Quantum Leap Healthcare Collaborative, participated.

In our submission, we championed the promise of SMART on FHIR.

SMART on FHIR:

  • Minimizes implementation burden.

Use of SMART on FHIR should be a centerpiece for automating emergency clinical trial data collection and expanding clinical research into underserved settings. It reduces the burden of research participation for institutions that have limited IT resources, with shorter implementation times and minimized privacy, security and implementation risk to sites.”

  • Integrates into clinical care without disrupting clinical workflows.
  • Is proven in production use.

As part of OneSource (now called OpenClinica Unite™), OpenClinica and Quantum Leap have deployed the OpenClinica Unite SMART on FHIR app to 17 large hospitals and healthcare networks for collecting data in multiple multi-site interventional clinical trials. SMART on FHIR has been critical to the success of those integrations. With OneSource, when it was clearly communicated to sites that the integration was SMART on FHIR-based, site IT teams understood that the effort would require minimal resources and be highly systematized, allowing projects to move to the top of the priority queue.

In practice, we have found each integration takes less than 15 hours of site technical time to complete.”

  • Allows for re-use and expansion, and hybrid data collection models.

The October 26, 2023 blog also noted OSTP is working with the HL7 FHIR Accelerator community on faster clinical trial data capture. As a member of Vulcan program, HL7’s newest FHIR Accelerator, OpenClinica celebrates the White House’s work with Vulcan HL7 to accelerate standardized approaches to data capture.

Vulcan is doing essential work to support next-generation standards for acquiring and utilizing health data in research. We’re at a critical juncture in clinical research where we can achieve higher quality, more comprehensive data and better engagement with providers and patients. Vulcan’s work is key to realizing those promises.

To learn more about the potential of SMART on FHIR, read the blog, The Future’s So Bright, I Gotta Wear Shades.

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