MORRISVILLE, N.C. & COLUMBUS, Ohio—Worldwide Clinical Trials Inc. and Deep Lens recently announced a new strategic alliance in oncology with the intent to support a new ecosystem for sponsors, researchers and care teams to accelerate cancer diagnoses and present clearer treatment and clinical trial options earlier in the process.
Currently, patient recruitment is a time-intensive, costly barrier to the execution of drug development programs. While more than 14,000 oncology clinical trials are actively recruiting patients, it is estimated that actual participation rates are as low as 3 percent of potential trial candidates. The new alliance will address this challenge by first collaborating to design a pilot study to marry innovative clinical trial designs and operational acumen with the VIPER platform in hopes of improving trial recruitment through real-time diagnosis and alerting to enhance coordination between research teams, care teams and patients.
What does this entail? To start with, it means accelerated oncology patient recruitment for clinical trials and an increase in clinical research as a care option (CRAACO), where the critical conversation with a patient is able to occur as soon as possible. The alliance aims to create trusted networks of precision diagnosis and clinical research options in order to provide pharmaceutical clients with a new platform for basket and umbrella study designs that can quickly process diagnosis and tumor response in real time. Lastly, the companies hope to support pre-competitive research into better clinical trial approaches by organizing “data clubs” (disease-specific consortia) of industry stakeholders.
Each company brings a wide range of expertise and industry experience to the alliance. Worldwide Clinical Trials is an award-winning, full-service, midsize, global contract research organization (CRO) boasting a network of more than 1,600 professionals in 60 countries in North and South America, Eastern and Western Europe, Russia and Asia. Founded by physicians committed to advancing medical science, Worldwide seeks to change the CRO experience from early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, by providing “world-class, full-service drug development services with predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders, oncology and rare diseases.”
Deep Lens supports Worldwide’s mission by offering a modernized, artificial intelligence-driven approach to pathology, expanding one of the world’s first digital pathology cloud platforms, VIPER, to include artificial intelligence, enhanced pathology workflow support and collaboration capabilities. In addition to providing essential workflow support to pathology teams, Deep Lens says it offers the most precise and timely source for identifying sites and patients for sponsored clinical trials.
“Cancer research is advancing at an incredible pace. We need to up our game as pathologists and CROs to deliver increased precision, speed and communication to find patients with particular disease subtypes or biomarkers,” said Dave Billiter, co-founder and CEO of Deep Lens. “With the global reach and scientific and operations expertise of Worldwide, we believe we can streamline clinical trial recruitment. And, just as importantly, oncologists can inform patients and their caregivers about clinical research options from day one.”
By working with Deep Lens on clinical trial recruitment, Worldwide believes it can reach upstream from the oncologist to the pathologist to identify eligible patients at the time of their diagnosis, which is much sooner than current methods.
The companies’ plans are to develop advances in digital pathology, deep learning and workflow for interventional and observational research in oncology; accelerate characterization of complex oncology sub-types and stages in real time; and engage study teams and care teams in meaningful patient conversations about treatment options.
In an interview with DDNews, Dave Billiter said that with the release of VIPER 3.0 the industry has an unprecedented ability to seamlessly adopt a free, cloud-based, AI-driven platform, transforming pathology labs worldwide and strengthening their role in the clinical trial process. The hope is that this will allow these studies to be completed on time, or even early and under budget.
Since VIPER is set up directly in pathology labs, it is reportedly easier to identify, notify and track candidates at the time of diagnosis. Once a trial site is verified and onboarded to the VIPER database, the patient’s pathology images are analyzed and and patients are matched to available trials. The trial coordinator at the site is alerted to a possible match, then the inclusion/exclusion criteria are analyzed for potential recruitment before commencing any other course of treatment.