Oncology endpoints and regulatory decision-making – bridging the gap between real-world and clinical trial data
Novel real-world endpoints derived from real-world data (RWD) offer a promising avenue for enhancing the regulatory decision-making process. By capturing data on patient outcomes, treatment patterns and real-world effectiveness in diverse clinical settings, these endpoints also support a broader shift towards a more patient-centered approach in drug development and regulation. Researchers are leveraging the wealth of RWD now available to develop innovative endpoints that reflect meaningful outcomes for patients. In 2021, the FDA awarded funding to Cardinal Health to support a lymphoma tumor response project that could help standardize RWD use.
In this interview, we speak with Richard “Scott” Swain, PhD, MPH of Cardinal Health about this research and the posters presented at ISPOR 2024 (May 6–8, 2024, Atlanta, USA), including:
- A Methodologic Solution to Missing Deauville Scores Using Imaging Report Data to Classify Lymphoma Treatment Response in Real-World Data
- A Novel Methodology for Assessing Response to Lymphoma Treatment in Real-World Studies – the Real-World Lugano (rwLugana) Study
- Feasibility of Using Positron Emission Tomography–Computed Tomography (PET-CT) Scans From Real-World Medical Record Data to Support Lymphoma Treatment Response Assessment
Click below to continue reading.
Richard Scott Swain, PhD, MPH
Director, Regulatory Science and Real-World Evidence
Cardinal Health, USA
In his role as Director of Regulatory Science and Real-World Evidence with Cardinal Health, Richard Swain’s primary duties include developing strategies to incorporate alternative study design methods, such as inclusion of RWE, to increase efficiency of clients’ regulatory submissions. Previously, as Lead Epidemiologist in the FDA/CDER Division of Epidemiology, he led the epidemiology team overseeing RWE safety and efficacy issues for oncology, hematology, and medical imaging products. He has over a decade of experience with epidemiological study design, protocol, and statistical analysis plan development, performing systematic literature reviews, and conducting research using large, multi-level electronic healthcare datasets in regulatory, consulting, and academic settings. His publication history includes abstracts and presentations for scientific conferences and manuscripts in peer-reviewed journals. Swain earned a PhD in Epidemiology, and a Certificate in Pharmacoepidemiology, from Johns Hopkins University and an MPH in Epidemiology, with a concentration infectious disease, at the George Washington University. His additional areas of expertise include RWE in oncology, Type 1 diabetes, self-harm and suicide, and clinical trials.
Sponsorship for this Peek Behind the Posters article was provided by Cardinal Health
© 2024 Cardinal Health. All Rights Reserved. CARDINAL HEALTH and the Cardinal Health LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other trademarks are the property of their respective owners. Patent cardinalhealth.com/patents.
