The company, a medical evidence network for clinical and imaging data, launched the Real World Imaging (RWI) due to a ‘clear need’ for regulatory-grade medical imaging data that's linkable to other information, explained Matthew Michela, CEO and president of Life Image.
The offering’s ability to connect to various datasets also supports government mandates to incorporate real world evidence (RWE) into the drug and device development process.
“It is well known that EHR, medical claims, and other traditional sources of RWE have a limited capacity to capture a patient's true clinical circumstances and, because they were designed primarily as billing mechanisms, in many cases actually provide biased data,” Michela told us.
‘Rich’ with clinical details, imaging data and associated reports – including those from pathology and radiology – are often more representative of a patient’s clinical situation, he explained. Though, this data has been difficult to access and use at scale in the past.
Life Image’s global interoperable digital platform, however, has been able to overcome many of the barriers, Michela explained, making RWI available, “curated, and linkable at enterprise scale, to support RWE programs in a meaningful way.”
The initial launch of the company’s RWI offering comprises more than 140,000 patients, over 90m images, and upwards of 240,000 associated reports, covering 25 anatomical areas, including head, heart, hands, breast, and brain, among others.
“There's a clear recognition that it is essential to complement existing RWE data in order to overcome the challenges of bias and homogeneity,” said Michela. “RWI, provided by Life Image, is heterogeneous and continuously growing, representing an expanding variety of demographics, temporal data, linked longitudinal records, and virtually every global manufacturer across all modalities.”
‘New questions and new answers’
In the US, Michela said the Food and Drug Administration (FDA) “has recognized the limitations and biases of historical and research-based medical datasets.”
“Second, the industry also recognizes that it needs ‘living’ data sets gathered in the real world that grow and evolve over time to accelerate development cycles since real world data can help address issues as they arise instead of many months or years later,” he added.
“Additionally, improvements in computational power generated by the maturing cloud industry, in combination with the explosion of the availability of a new variety of data types, facilitates both new questions and new answers that improve the end-results of trial efforts.”
In addition to RWI data, Life Image also provides services including end-to-end management for de-identification, data curation and linking.
Life Image in March of this year announced a strategic partnership with Mendel Health, a San Francisco, CA-headquartered company using artificial intelligence (AI) to examine unstructured data in medical literature and EHRs.
Through the partnership, Life Image is using Mendel’s platform to facilitate clinical trial site location as well as patient recruitment for oncology studies.
According to the company, Mendel Brain yields 30 to 50% more patients than traditional methods, using machine learning (ML) to process information and continuously improve outcomes to decrease the time between patient eligibility and identification.
Said Michela, “Our inventory grows daily with the application of our value-added services that provide end-to-end management for de-identification, data curation, normalization, and the ability to link across other datasets including EHR, claims, genetics, and other phenotypical commercial and public data assets.”