In this free webinar, learn about the various type of registries and what differentiates them. Attendees will be able to identify the right type of data for their needs and see what types of questions can be answered with registry data at various stages in drug development. The featured speakers will also discuss the application of scientific methods and analysis to transform registry data into usable real-world evidence.
TORONTO, May 22, 2024 /PRNewswire-PRWeb/ -- DDiscover an informative webinar that focuses on the evolving role of registry data in product development, approval and post-marketing value demonstration, as well as the advantages they offer.
The use of real-world evidence (RWE) in drug development has been fueled by the increased acceptance of RWE by stakeholders such as regulatory agencies, health technology assessment bodies and payers, as well as the plethora of real-world data (RWD) sources.
Protocolized disease registries are purpose-built for research, making them one of the most clinically rich sources of RWD. Registries allow the collection of fit-for-purpose data and are an acknowledged source for observational RWE generation, especially in rare diseases where a small number of patients are distributed across broad geographies.
Registries are most often used to fulfill post-approval safety commitments, to monitor or compare treatment patterns and effectiveness outcomes in the real world and to describe the natural history of diseases. In this webinar, the speakers will focus on the following topics:
- The type of RWD that can be collected in registries
- How RWD can be used to conduct nested, customized registry-based studies
- Within one registry, how can it be ensured that data are collected consistently across patients, practice settings, geography and time?
- Is there an existing registry that collects the required data or is a bespoke registry required?
- What do regulators say about using RWD from registries to inform their decision-making?
- Can registry data be used and linked to other data sources?
- How can you go from data to actionable insights?
Registries also offer unique and rich data solutions to provide differentiated insights throughout the drug development process from identifying unmet needs and market potential to optimizing clinical trial design, contextualizing safety outcomes and serving as external control arms to supporting regulatory requirements and differentiation in therapeutic effectiveness.
The growing demand for regulatory-grade RWD provides exciting opportunities for researchers seeking rich clinical data to fill RWD gaps inherent to electronic medical records (EMRs) and payer claims. Yet, this new landscape has to be carefully navigated to ensure the right investment is made.
Register for this webinar to gain insights into how RWE and RWD from registries enhance clinical development, approval and post-marketing analyses, particularly for rare diseases.
Join experts from the PPD clinical research business of Thermo Fisher Scientific, Peter Wahl, Vice President and Global Head of Scientific Affairs, CorEvitas; Heather Litman, PhD, Vice President of Biostatistics, CorEvitas; Delphine Saragoussi, Executive Director, Real-World Evidence, Epidemiology and Scientific Affairs, Evidera; Nahila Justo, Executive Director, RWE Integrated Solutions, Evidera; and Javier Cid, Senior Research Scientist, Data Analytics, Evidera, for the live webinar on Thursday, June 6, 2024, at 10am EDT (3pm BST/UK).
For more information, or to register for this event, visit Registries: Supercharging Real-World Evidence for Drug Development and Approval.
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