By Bill Lynch, Director of Business Development, TeraMedica Division of Fujifilm
As COVID-19 continues to rapidly spread around the world, scientists are scrambling to identify diagnostics, therapeutics, and vaccines that can help put a stop to the relentless outbreak. To help expedite the extensive clinical trial process, many biotech firms are working with contract research organizations (CROs) to quickly identify real-world evidence (RWE) and real-world data (RWD) as proof points for the efficacy of certain drugs. For a quick refresher on Research 101, RWE is clinical evidence that points to the potential benefits and/or risks of a medical product. RWD is data that’s routinely collected from a variety of sources to show how a population’s health status has subsequently evolved over time.
Why this heightened focus on RWE and RWD?
One obvious factor is the U.S. Food and Drug Administration (FDA). In 2016, Congress passed the 21st Century Cures Act. This law was designed to help accelerate medical product development and bring new innovations to patients who need them faster. Under this law, Congress mandates the FDA’s use of digital data to make regulatory decisions and maintain post-market safety. And what, you might ask, is a prime example of digital data that can be used as RWE/RWD? You guessed it—medical imaging!
Yes, those CTs, MRIs, ultrasounds, PET scans, and so on that are stored in various data repositories play an increasingly important role as RWE/RWD for clinical trials. A few prime applications include:
- Mechanism of action: Imaging can help determine if the expected action of a drug can be observed. For example, did a new cancer drug reduce the size of the malignant tumor or alter its characteristics to slow overall progression?
- Biomarkers: Certain imaging biomarkers can help scientists quickly make objective decisions related to drug safety and efficacy. This increased efficiency also reduces overall research and development (R&D) timelines and expenses during the early phases of clinical trials.
- Surrogate endpoints: Imaging biomarkers can also act as a surrogate endpoint, or “an endpoint used as a substitute for a direct measure of how a patient feels, functions, or survives.” Relying on imaging as this endpoint allows scientists to quickly access results that have strong statistical power when assessing a new drug’s efficacy.
So RWD/RWE is critical for biotech advancements, and imaging is a great resource. What’s the problem?
Two words: imaging liquidity. At a high level, imaging liquidity refers to the ability to store images and their associated metadata (those hundreds of rich-data fields that accompany your images) in ways that are easily searchable and accessible throughout the enterprise and via your software systems of choice. The challenge with imaging liquidity, however, is that the various imaging software systems that most CROs or biotech firms rely on are not interoperable. As a result, it is extremely challenging, if not impossible, to use these systems to search, locate, and save the images that can serve as RWD/RWE during a clinical trial.
Is there a way for imaging data to be searchable and accessible to those who need it for drug development?
Fortunately, there is a solution that can link all health IT systems and allow seamless access to the complete patient-imaging record. The solution is known as a vendor-neutral archive, or VNA. Widely familiar in the enterprise-imaging arena, though often a foreign concept to those in the biotech or clinical research space, a VNA bypasses the need to switch CROs or pursue the dreaded system rip-and-replace method. Instead, the VNA simply optimizes and unifies the systems already in place to provide the complete patient-imaging record to those who need it.
How does a VNA work?
The top VNAs can run on-site or in the cloud, and they employ the latest industry standards, including DICOM, DICOMweb, HL7, FHIR, XDS, and RESTFUL Web services, to seamlessly exchange information between systems. They then extract exact copies of images and the associated metadata from the source systems and store them in secure, standard formats so the data is accessible to the CRO or biotech firm’s software systems.
Remember that term “imaging liquidity?” That’s what a VNA enables for the biotech sector. By indexing all the metadata, hundreds of thousands of images can easily be searched in seconds, allowing CROs and their biotech counterparts to quickly locate and use the information they need to help fuel biotech breakthroughs.
Where can I learn more?
Interested to know more about how a VNA can bring complete imaging value to your clinical trial? Be sure to download our white paper from the TeraMedica Division of Fujifilm, and contact us directly to schedule a demo of our industry-leading Synapse® VNA.
This blog post was syndicated from FUJIFILM Medical Systems, U.S.A., Inc.’s blog, The EI Connection.
By Sara Osberger, Senior Director of Marketing, Enterprise Imaging, FUJIFILM Medical Systems, U.S.A., Inc.
Today’s CIO’s and healthcare IT professionals need to manage an enormous array of systems and technology that span and serve the entire institution. Add to that the fact that technology is constantly changing and evolving, and it’s no wonder how any CIO or IT professional can keep pace with all of what’s “out there.”
Most of you are likely familiar with vendor-neutral archive technology, or VNA, which was designed for imaging interoperability. Fujifilm’s Best in KLAS Synapse® VNA provides secure, easy-to-manage storage, and allows access to the complete patient imaging record. It also integrates with electronic health records (EHRs) and health information technology (HIT) systems to provide the complete patient health picture.
But let’s examine the roots of VNA—why VNA came about and took hold—so we can better understand the reach of this technology now.
As many may recall, it all started with picture archiving communication systems (PACS). For more than four decades radiology departments have used PACS to manage and archive DICOM images. But as more vendors entered the market with their own variations of PACS technology and DICOM conformance, the ability to easily exchange and view images among different PACS systems became challenging. Add in the influx of specialty departments now curating images in a variety of non-DICOM formats—AVI, MPEG, WAV, JPG, PDF, PNG—and it’s clear why the VNA was born. It presents a simple, all-inclusive image archive and management solution.
Perhaps you’ve helped choose and implement a VNA solution for your organization. If so, then you well know how VNAs are changing the way clinical teams capture, view, store, manage, and distribute medical images and patient content. They are the wings, if you will, that are empowering clinicians across the enterprise to work more swiftly, more collaboratively, and to drive better patient outcomes.
Let’s take just one example. Think about how VNA technology can boost surgical efficiency and help improve patient care. After all, today’s surgeons require the same content sharing and storage capabilities that were once the domain of radiology. Consider, for instance, how previously collected enterprise-wide images or videos may be useful during surgical planning and pre-op. But how can surgeons quickly have these images at their fingertips?
With Fujifilm’s Synapse Mobility Enterprise Viewer, PACS and 3D, content is retrieved directly from the source archive (PACS, VNA, etc.) and accessible to the user from a PC, mobile device or browser. The benefit of an enterprise viewer is the ability to provide access to the patient’s full medical imaging record in the EHR, regardless of the specialty department in which it was acquired. Enterprise viewers can display multiple images simultaneously, display patient photos, and play patient-centric video or audio content.
The comprehensive Fujifilm Synapse solution also enables surgeons to be productive and efficient in surgical planning wherever they might be working—in the hospital setting, at their office, off-site, at home, and so on.
Now let’s take it a step further. Once in the OR, a surgeon may need to reference previous PACS images (MRI, CT, ultrasound, etc.) viewed alongside endoscopic images as PiP, PaP, etc., during the procedure itself. With Fujifilm Systems Integration, alongside our VNA or your PACS system, surgeons can access all the images in one place and route them to any monitor destination in the OR. All surgical images and videos captured are saved directly to that patient’s record in the VNA for storage post-procedure, as well as notification to and immediately accessible in the EHR.
With millions of inpatient surgeries performed annually across the nation, today’s busy surgeons demand a holistic, robust workflow solution that provides them with the comprehensive diagnostic imaging they need to perform operations successfully. That’s what our systems integration technology is all about.
There is no need to purchase separate middleware systems or archives by specialty. In addition, the VNA also allows your organization to collapse existing storage silos and can prevent multiple specialties from purchasing on-going departmental solutions. This is more efficient because the enterprise-wide needs can be better achieved with a single platform. It’s also more cost-effective because separate departmental solutions require their own support, maintenance, and integration—and that can add up to big dollars.
OR integration technology from Fujifilm, coupled with Fujifilm’s VNA technology, allows clinicians to integrate more specialties, more devices, and more data than any other system on the market—all from one central data repository.
Think about how your healthcare organization can benefit from Fujifilm’s VNA paired with OR integration technology. They can help your surgeons perform more successfully and make your quality metrics soar. With the right technology, good things take flight.
This blog post was syndicated from FUJIFILM Medical Systems, U.S.A., Inc.’s blog, The EI Connection.