Natural History Studies in Oncology Clinical Trials

This document is a technical report that outlines the role of natural history (NH) studies in enhancing the design and execution of oncology clinical trials. It explains how NH studies utilize real-world data from registries, diagnostics, and patient records to track disease progression without specific trial interventions. The report details the benefits of NH studies, including improved patient engagement, more efficient trial designs, and better dose selection. It also discusses the importance of using NH studies to identify suitable patient populations for clinical trials, particularly in the context of rare diseases. The report highlights guidance from regulatory bodies like the FDA and EMA regarding the use of real-world data in clinical trials. Furthermore, it presents various types of NH studies, such as retrospective, prospective, cross-sectional, and longitudinal studies, and emphasizes the significance of understanding patient demographics and treatment protocols to ensure equitable access to clinical trials. Overall, the report advocates for a patient-centric approach in clinical trial design to improve outcomes and expedite the delivery of therapies.