Empowering a Real-World Data-Driven Approach to Clinical Trial Site Selection

Clinical trials are struggling, just look at the statistics. Despite all of the innovation and breakthroughs in drug discovery over the last several years, it still takes 10-15 years and about $1 billion to develop a new therapy. Globally, more than 80% of trials fail to meet enrollment deadlines, resulting in costly extensions, addition of new study sites, or outright study failure. On top of all of that, according to research we published last year, clinical trial populations often do not mirror the real-world patient populations they are seeking to help treat. 

There are many reasons for this, of course. First, there is the enormity and complexity of the challenge of safely bringing a new drug to market. Then, there are countless challenges around study design, funding, patient access and patient engagement. But the biggest impediment to improving clinical trial success rates is the structural inefficiency of the traditional approach to study design and patient recruitment. Recently, Verana Health launched a new solution designed to change that status quo by implementing a real-world data-driven approach to the clinical trial site selection process.

Introducing VeraSite

Our solution is called VeraSite, which is a tool that utilizes exclusive real-world, de-identified patient data to find potential groups of patients at clinical trial sites. It works by tapping into electronic health record (EHR) data from the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight) to enable clinical trial sponsors and contract research organizations (CROs) to quickly identify participating practices that have consented to share their practice information. Also viewable is the practice’s clinical expertise and de-identified, aggregate information about patient populations that are matched to unique study protocols. 

This is a departure from the traditional approach to site selection, whereby a pharmaceutical sponsor would work with a CRO to identify a number of clinical sites from their provider networks and then recruit patients through the providers and direct-to-patient advertising in regions where those sites are located. That approach—which has been the industry standard for decades—typically focuses on the same handful of sites with whom they’ve already established relationships and results in most studies being conducted in major research centers in large cities. This strategy may limit access to patients and providers who are outside the orbit of those big centers.

With VeraSite, clinical trial sponsors and CROs are able to guide their clinical trial site selection strategy based on real-time, real-world patient data. This allows them to identify participating sites that are seeing specific patients with particular patterns of diagnoses, procedure history, visual acuity results, detailed demographics or several other variables. 

Transforming Clinical Development

Clinical trial sponsors and CROs are also able to do this with the confidence that they are accessing a more robust universe of potential eligible patients. Because Verana Health is the exclusive data curation and analytics partner for the Academy’s IRIS Registry, one of the largest specialty society clinical data registries in all of medicine – containing de-identified longitudinal patient data collected from nearly 16,000 contributing clinicians – we are able to provide an incredibly detailed, near real-time snapshot of the ophthalmologic patient landscape. De-identified patient data collected through VeraSite, with the consent of a practice, is refreshed regularly. Sponsors and CROs are able to identify groups of de-identified patients using filters such as specific diagnoses, patterns of treatment, visual acuity results, intraocular pressure reading and demographics, which allow them to match detailed clinical data with specific patient recruitment goals. They are also able to understand the practice’s level of clinical trials experience, including specific study experience across more than 23 ophthalmology indications. 

Needless to say, we are very excited about the prospect of using real-world evidence (RWE) to improve the clinical trial site selection process with VeraSite, but we’re also thinking much bigger about the advances this will mean in supporting the drug development lifecycle. 

The fundamental underpinnings of VeraSite have applications that extend far beyond site selection. The comprehensive, highly granular view of the ophthalmologic patient population is powered by artificial intelligence, such as machine learning and natural language processing, that make it possible to extract and organize both structured data (e.g., diagnosis and procedural codes) and unstructured data (e.g., clinician notes and images) and quickly draw meaningful insights from those datasets. To view an example of how we’ve supported a client with their phase II site selection, read the white paper here. Extracting and organizing both structured and unstructured data to quickly draw insights from datasets is a game-changer for patient-centered research and analytics. This will help influence all aspects of life sciences strategy from clinical development to commercialization to health economic and outcomes research (HEOR) and RWE. 

To learn more about VeraSite and the breakthrough role it can play in transforming clinical trial site selection, please visit: https://www.veranahealth.com/data-and-technology/verasite/