In an era defined by rapid advancements in technology and science, healthcare research and clinical trials are undergoing a transformative shift. At the heart of this revolution is data—vast, diverse, and ever-growing—and the collaborative efforts of stakeholders...
The use of real-world evidence (RWE) in regulatory decision-making and health technology assessments (HTA) is gaining traction, particularly in the evolving landscape of oncology pharmacotherapeutics in Europe where navigating the drug approval and market access...
In June 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining the need for “Diversity Action Plans” as a way for clinical trial sponsors to demonstrate their consideration toward trial representation. Affecting phase 3 studies, and others...
Cancer clinical trials have long been the cornerstone of advancements in oncology, guiding the development of new therapies and improving patient outcomes. However, traditional clinical trials often face challenges such as lengthy durations, high costs, and difficulty...
In the evolving landscape of pharmacovigilance (PV), market authorization holders (MAHs) face mounting pressure to integrate real-world data (RWD) into their safety monitoring processes. This shift is propelled by a combination of regulatory initiatives and the...
Optimizing Data Quality in Pharmacoepidemiologic Studies Authors: Jeffrey Brown, PhD, Chief Scientific Officer at TriNetX and Matvey Palchuk, MD, Chief Medical Informatics Officer at TriNetX Pharmacoepidemiology, the study of the use and effects of drugs in large...
