Integration of Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) Data

Oregon Convention Center 

Room: CC-D136 

Intersectionality of RCTs and Registries and its Potential to Optimize Clinical Trial Operations can be challenging but remains critical. Registry data can be particularly valuable and well-utilized in certain therapeutic areas where they can provide comprehensive and real-world insights into disease progression, patient outcomes, treatment effectiveness, safety profiles. There are some therapeutic areas where registry data are more suitable and can be maximally utilized, e.g., oncology, rare diseases, transplantation, neurodegenerative and neuromuscular. In others, it is usually with regards to where they are used to gain insights of on effectiveness and safety of treatments irrespective of therapeutic area, e.g., pregnancy and reproductive health, pediatrics, and effects on cardiovascular outcomes. In these therapeutic areas, registry data can complement clinical trial data (RCTs) by providing insights from a broader and more diverse patient population, capturing real-world treatment patterns, and enabling long-term follow-up. Registry data are particularly valuable for observational studies, safety surveillance, health outcomes research, and comparative effectiveness studies. While the use registries numerous benefits, but it also comes with several challenges that need to be carefully addressed to ensure the quality, reliability, and ethical use of the data. These include selection bias and generalizability, data quality and completeness, confounding, endpoint definition and adjudication, longitudinal follow-Up and attrition, data privacy and security, data standardization and harmonization, data linkage and integration, ethical considerations, regulatory and compliance Issues. A panel from industry, academia and government will discuss their views on this topic at the invited panel.

Chair: Margaret Gamalo, PhD, FASA, VP- Pfizer Inc., PA, USA
Panelists:
Prof. Lehana Thabane, PhD, FASA, McMaster University, CANADA
Jianchang Lin, Ph.D., Senior Director, Statistics, Takeda Pharmaceutical Company Limited, Boston, MA, USA
Ilya Lipkovich, PhD, FASA, Executive Director, Eli Lilly and Company, Indianapolis, IN, USA
Theodore (Ted) Lystig, PhD, FASA, SVP, Chief Analytics Officer, Bridge Bio Therapeutics, CA, USA

Yes

Section for Statistical Programmers and Analysts

Biopharmaceutical Section

Caucus for Women in Statistics