CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Sony Salzman spoke with Bill Row, MBA, MS, divisional principal, Real World Evidence, Commercialization & Outcomes, at Icon. His focus is commercial applications of real-world evidence late phase studies for both pharmaceutical companies and CROs.

Q: How are CROs responding to the growing demand from payers and regulators for real-world evidence collection?

A: Real-world data can now be collected, stored, analyzed and presented to bring the benefits of real-world evidence to clinical research and commercialization decision making. There are emerging applications in planning trials and recruiting patients, supporting regulatory decisions and developing product value propositions.

Icon, as well as other leading CROs, are responding in a way that is aligned with their clients’ organizations. Similar to pharmaceutical companies, CROs are carving out real-world evidence groups responsible for collecting, standardizing and analyzing real-world data. These groups are able to provide an integrated approach to different real-world evidence stakeholders.

These groups, ideally, are staffed with experts in medical affairs, pricing and market access, health economics and outcomes research (HEOR), epidemiology, electronic clinical outcomes assessments (eCOA), patient experience, marketing, real-world data technology and research operations—in other words, mirroring and supplementing the capabilities on the client side.

Q: What does “intelligent” data collection mean to you?

A: There is no lack of real-world data available today; the challenge, therefore, is not in acquiring data, but in having the expertise to know what data will be most effective in answering a given research question … and then in being able to draw insights from it.

We believe that “intelligent” data collection for each research challenge requires being “data- and data-source agnostic.” In other words, to best serve sponsors’ research needs, a CRO must be willing and able to collect and work with data from any available source to create a bespoke solution to the research question. The research question drives the data collection and aggregation effort.

At the same time, to be able to benefit from this approach, sponsors must develop an operating model capable of responding to stakeholders’ different evidentiary needs. Within this new model, clinical teams can use real-world evidence to align product development with specific unmet patient needs, and commercial teams can use it to demonstrate improved comparative efficacy and cost effectiveness to payers.

Before generating evidence, they then must assess their evidence needs and develop a thoughtful, comprehensive evidence strategy. The right strategy will bring together technology and the expertise of real-world data specialists who can ensure that the data assets will meet the study endpoints most efficiently.

One innovative approach to developing evidence is to create a virtual registry powered by electronic health records (EHR) and supplemented with patient-reported data collected by the physician at the point of care and then linking to that specific patient’s claims/prescription data. This results in more robust and longitudinal reporting of the entire patient pathway and treatment experience. Thus, data are captured in a centralized data repository and reflect decisions made in usual care—all without having to consent a single patient. Such a virtual registry would rely on a large, cloud-based EHR platform to expedite patient identification and facilitate data collection. 

Q: Can you characterize any new and emerging trends within the myriad of technology solutions around real-world evidence collection and utilization?

A: While a number of analytical tools can be layered over a single large data set, supporting the entire clinical and commercial continuum requires a robust, real-world evidence technology platform that can aggregate large, disparate datasets into a common data model. Such a fit-for-purpose technology platform is necessary to leverage a cohesive real-world evidence strategy and maximize the value to be derived from real-world data sources.

The right platform will maximize the company’s return on investment in both its technology and data assets by supporting ad hoc analytics, market share, long-term safety studies, virtual registries, comparative effectiveness research, patient profiling and studies of disease progression and therapy patterns, as well as patient recruitment and protocol feasibility.

The technology platform should include components for consuming, aggregating, and processing the data, bringing together multiple input feeds together into a transactional data store that offers a single source of the truth.

Users should have access to the raw data and allow them to define patient cohorts. While it is essential to have pre-packaged analyses, it is also important to have the ability to customize and shape the reporting outputs as needed through ad hoc queries. 

This article was reprinted from Volume 21, Issue 35, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »