MORRISVILLE, N.C., and SAN FRANCISCO, Worldwide Clinical Trials, Inc. (Worldwide), an award-winning, full-service CRO, and Datavant, Inc., a healthcare technology company focused on securely organizing and linking datasets to support clinical research, today announced the companies are partnering to enhance clinical research and drive urgent advances in neurodegenerative diseases.
Initially, the combination of Worldwide’s therapeutic expertise in neurodegenerative diseases and clinical trials regimen and Datavant’s focus on organizing and structuring healthcare data will set the foundation for a collaboration that addresses:
- Understanding why clinical trials in neurodegenerative diseases fail;
- The impact of real-world evidence and big data to improve clinical trial conduct; and
- Opportunities to exploit digital technology for prolonged and extended trial monitoring.
Neurodegenerative diseases, such Parkinson’s, Alzheimer’s, Huntington’s disorders and amyotrophic lateral sclerosis (ALS), represent an increasing challenge to healthcare systems throughout the world. For example, the estimated annual cost to the United States of just nine common neurological diseases is staggering, totaling nearly $800 billion. This amount will increase even further as the elderly segment of the population nearly doubles, increasing to 83.7 million by 2050.[i] Yet, these diseases typically have a slow and erratic clinical course, a subtle onset, and symptoms are only observed when a significant proportion of neurons are already lost, posing specific challenges for drug discovery, development and research.
The experts at Worldwide have been on the front lines of neurodegenerative disease research since the advent of cholinesterase inhibitors in the late 1970s and bring a deep appreciation of the pathophysiological mechanisms, innovative clinical trial designs and operations rigor needed to move the industry forward.
Datavant brings an ability to link traditional real-world medical data from electronic health records (EHRs), claims, genomics and diagnostics, for example, with emerging non-traditional sources, such as socioeconomic data, wearables/devices, behavioral data and more. Datavant’s software facilitates the creation of a holistic view of anonymous datasets, combining multiple data layers into a single de-identified dataset to help answer questions that were previously infeasible to address.
The strategic collaboration between the companies is designed to:
- Deliver an uncommon combination of integrated clinical trial data with real-world datasets for better insights that will drive improvements in existing protocol, strategies and methods, which could provide answers to transforming success in neurodegenerative disease clinical trials.
- Address the obstacles clinical trials currently face, such as slow recruitment, low patient engagement, inflexible design, suboptimal use of real-world evidence (RWE) and limited observations. As a result, the partnership will further enhance clinical trials methodologies and algorithms.
Initially, the companies will collaborate to design a high-profile pilot study to marry traditional clinical operations with external data assets. The intent is to explore opportunities to enhance trial monitoring through focusing on patient compliance, adherence and overall enrollment feasibility.
“Together, Worldwide and Datavant are focused on exploring the uncommon value big data and next-generation analytics, combined with robust clinical trial experience and deep therapeutic expertise, can deliver throughout the research process. For Worldwide, the promise of advancing drug development and unlocking novel opportunities for innovative trial design and interpretation is particularly important, as we strive every day to improve the lives of patients and populations suffering from the complex ravages of neurodegenerative disease,” said Peter Benton, president and COO, Worldwide Clinical Trials.
“The challenges that continue to persist in neurodegenerative diseases highlight the need for novel and evolved approaches to understanding both disease mechanics and patient progression. We believe our partnership with Worldwide takes an important step to revisiting and improving upon elements of trial design and operations that have remained stubborn barriers to progress in the field,” said Travis May, co-founder and CEO, Datavant.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,600 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders (IMID), oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit https://www.worldwide.com.
Datavant is a San Francisco-based company dedicated to organizing and linking the world’s healthcare data. Datavant helps data owners manage the privacy, security, compliance and trust required to enable safe data sharing. Datavant’s vision is backed by Roivant Sciences, SoftBank Vision Fund and Founders Fund.
Worldwide Clinical Trials:
Sherri Stuart, Vice President, Global Marketing and Communications
Sam Roosz, Head of Partnerships
[i] https://www.prnewswire.com/news-releases/the-us-burden-of-neurological-disease-is-nearly-800-billionyear-according-to-new-american-neurological-association-study-300432057.html. Accessed April 23, 2018.