Meeting Evidentiary Needs with Electronic Health Records: Transformative Applications in Observational Studies and Pragmatic Clinical Trials

As the healthcare system continues to progress in the use of technology to track and improve patient care, Electronic Health Record (EHR) systems are becoming a burgeoning source of Real-World Data (RWD) for researchers and manufacturers alike. EHRs can be a cost-effective way to identify, access and analyse data needed for peri- and post-approval research studies. In this webinar, we will focus on how RWD can be quickly applied to Observational Studies and Pragmatic Clinical Trials (PCTs), as well as what challenges researchers face in successful application of RWD to these studies.

Observational Studies, being non-interventional in nature, have traditionally been conducted by collecting data via the establishment of patient registries. This can be an expensive start-up process and long term management can be cumbersome. As EHR databases continue to grow and offer an abundance of RWD, their use as viable sources for retrospective and prospective analyses can grow as well with less cost and resourcing impact.

Pragmatic Clinical Trials (PCTs) are known for having broader eligibility criteria than Randomized Clinical Trials (RCTs) and are conducted on a much larger patient group in order to produce more generalized population-based results. Identifying patients for PCTs can be a laborious process that requires dependence on providers’ initiative to drive patient recruitment. EHR systems are becoming the backbone of PCTs and provide a method to identify, enrol, and monitor patients while capturing treatment details and outcomes for study as the trial continues. In this case, use of the EHR system can reduce the cost of these studies through automating the patient identification process as well as others.

While EHRs demonstrate a great benefit to the post-approval clinical research community, challenges do exist, some of which will be addressed as EHR technology progresses and some of which are inherent to any secondary data source. Researchers will have to be aware of these nuances in data capture and systems interoperability to leverage the usefulness of EHRs in conducting scientifically sound studies and trials.

As EHR-driven studies advance with this ever-present RWD source, biopharmaceutical, medical device and diagnostic manufacturers should look to the benefit these studies can provide to stay ahead of the curve with real-world evidence that supports the value of their marketed products in continuing to expand access and support reimbursement.

Key Insights:

This webinar will discuss the advancements, opportunities, and challenges around the current and future use of Real-World Data from EHR systems in observational studies and pragmatic clinical trials. Attendees will gain valuable insights on:

• The current demand for Real World Data to provide post-approval reporting and inform manufacturer business decisions
• Development of RWD guidelines and requirements by regulators in the US and EU markets
• How RWD is being applied to post-marketing research including observational trials and Pragmatic Clinical Trials

Speakers

Jim Carroll, Vice President, Real World Evidence, ICON

Jim Carroll is Vice President, Real World Evidence (RWE) for ICON’s Commercialisation and Outcomes service area. In this role Jim is responsible for leading the company’s RWE center of excellence hub in developing Real World Data (RWD) and technology based solutions that support bioPharmaceutical companies who are seeking to expand labeling and market access, while staying ahead of the growing demand for evidentiary requirements. Under Jim’s leadership, ICON helps customers to demonstrate, within a real world context, their products’ unique efficacy and safety attributes.

Previous to joining ICON, Jim spent three years with inVentiv Health. While there he led the formation of a business unit focused on the use of various RWD sources to deliver data driven, integrated clinical trial feasibility and patient recruitment services, helping sponsor companies to shorten the patient enrollment timeline. Before joining inVentiv, Jim spent nearly ten years at IMS Health developing and commercializing analytic products and services that utilize various types of RWD, both US and ex-US sources. He holds an MBA degree from the Questrom School at Boston University and a BS degree in Chemistry from the University of Massachusetts at Amherst.

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Rob Sambrook, Divisional Principal, Epidemiology, ICON

Robert is the head of ICON’s epidemiology practice, an integral part of ICON’s Commercialisation and Outcomes group. Robert manages a team of 20 epidemiologists and analysts, with a strong focus on design, implementation, analysis and reporting for programs gathering and synthesising real world data (RWD). He has been at ICON since 2009, and has over 20 years’ experience in clinical and health outcomes research, in a wide range of businesses and roles, including data management, project management, medical writing, operations, and late phase/epidemiological consulting, in both the public and private sector.

His experience includes design, implementation and reporting for Phase I to IV clinical trials, and for large post-marketing studies, including pragmatic observational studies and disease registries. He is also experienced in conducting systematic literature reviews, and building economic models. Robert holds a BSc from the University of Wales, and an MSc from the University of British Columbia.

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