PAREXEL and Datavant Partner to Enhance Drug Development and Commercialization with Advanced Data and Real-World Evidence Analytics
PAREXEL and Datavant recently announced they are partnering to enhance clinical study design and operations, as well as the generation of real-world evidence, by enabling the linking of healthcare data from a variety of real-world and clinical study data sources.
To learn more about this collaboration and what it means for the life sciences industry, we sat down with PAREXEL’s Jason Martin, Corporate Vice President, Global Data Operations, and Datavant co-founder and CEO, Travis May.
Can you tell us a little bit about Datavant and why the partnership was formed?
Travis May (TM): Datavant is a healthcare technology company that is focused on reducing the friction involved in sharing and linking health data. Through enabling the connection of de-identified patient datasets, Datavant's solutions help to break down data siloes and enable healthcare companies to more rapidly build and enhance their real-world data assets.
PAREXEL has long led the charge in implementing innovative new practices in the clinical trial space, and shares Datavant's vision for a data-driven approach to advancing the design and conduct of clinical trials. The pairing of PAREXEL's deep clinical trial expertise and Datavant's ability to integrate healthcare datasets holds the potential to unlock novel approaches to drug development, and ultimately deliver more treatment options to patients who need them.
Jason Martin (JM): The data for an individual’s health care utilization and health records for an individual are often spread across many sources without a common index to link up patient records. It is challenging and sometimes impossible to have a single longitudinal healthcare view of an individual. Research performed using this data falls short of its potential, and sometimes can never be completed. Datavant has a solution that enables the linking of these disparate datasets through a distributed indexing approach.
Together, PAREXEL and Datavant can aim to help life sciences companies markedly improve the design and conduct of their clinical studies and answer research questions that previously had alluded traditional approaches.
There is a significant amount of healthcare data available to sponsors today, yet leveraging this data remains a challenge. What is preventing the industry from using this data to improve drug development?
TM: While the amount of data generated per patient is rapidly growing year after year, as Jason mentioned, the utility of this data is limited because it is siloed. The rules and standards put in place to protect patient privacy are essential, but they also have had the undesired side effect of limiting the ability to connect valuable data in order to improve the care of patients. PAREXEL and Datavant are working to overcome this challenge through the deployment of methods that enable healthcare data to be de-siloed and linked while protecting the privacy of patients.
Datavant has technology capabilities that enable the linking of healthcare data form a variety of real-world and clinical study data sources. How will PAREXEL leverage this data to help clients?
JM: The use of Datavant technology will expand PAREXEL’s ability to integrate real-world data sources across all research phases: from Phase II/III clinical trials focused on the demonstration of safety and efficacy to Phase IV post-marketing, health economics, and outcomes research studies that support product commercialization. Innovators who address the problem of integrating and normalizing healthcare data open new research channels for those who have historically been unable to fully utilize real-world data sources. PAREXEL’s partnership with Datavant is a significant step forward in our approach to leverage real-world data in a meaningful way along the drug development journey.
A recent report released by the Economist Intelligence Unit and commissioned by PAREXEL found that drugs developed using real-world data had a 21 percent higher likelihood of launch, and real-world data studies resulted in reduced recruitment time. The report also identified advanced data analytics - including sharing of data across established siloes – as a key enabler to innovation in drug development and commercialization. How can companies leverage these innovations to enhance drug development?
JM: The role of real-world data in the acceleration of clinical study timelines and answering previously elusive clinical research questions can be explained by two perspectives.
First, real-world data can be utilized to readily identify patient populations that are ideally suited for clinical trial participation, allowing sponsors and CROs to recruit from sites with access to those patients. This turns the traditional paradigm of site recruitment, where 20 percent of sites enroll 80 percent of patients, on its head, allowing study teams to reduce the number of non-productive sites recruited while optimizing the number of productive sites utilized on any given study. This enables faster patient recruitment and clinical study delivery while reducing overall cost.
Second, the utilization of real-world data enables clinical researchers to design better clinical trials. Inclusion of real-world data in the final protocol will generate evidence approximating the real world, helping better understand the true product safety and efficacy. This bridges the divide that has historically existed between a drug development enterprise focused on what FDA stakeholders have defined as “precise answers to narrow questions” in favor of a paradigm that widens the research frame in anticipation of actual clinical practice. Pragmatic studies, safety surveillance programs and registries powered by real-world data sources can and should be leveraged to speed patient access to medicines.
Real-world data highlights which treatments are safer and more efficacious for specific populations, at which doses and in which combinations by examination of near and long-term patient outcomes. Inclusion of real-world data in these contexts ultimately reduces risks to patients. Most importantly it allows researchers to more quickly discover which products are less beneficial or potentially harmful to patients in the long run. It can also shift clinical practice to optimize patient treatments while ensuring coverage for those products that work best.
TM: The process of developing a pharmaceutical asset is ultimately one of generating and analyzing data, so it makes sense that better use of real-world data will lead to improved approaches to clinical development. To get there, the first step is to deploy solutions that de-silo data and make it available for analysis. The second is asking the right questions to extract actionable insights from the data. The pairing of PAREXEL and Datavant has produced a market-leading team that is particularly well-suited to address this challenge.
What are the next steps for PAREXEL and Datavant?
TM: The initial focus of the partnership is to expand and enhance PAREXEL's existing data assets and analytical capabilities. Building on top of that foundation, PAREXEL and Datavant will work to integrate those real-world data assets with clinical trial data to advance hybrid study designs.
JM: PAREXEL has already successfully piloted the Datavant solution and we are excited to start leveraging our expanded capabilities in upcoming projects where real-world data is required.
Clinical Data Management
Data Analytics & Insights
Data Driven Insights