Natural History Studies in Gene Therapy Trials: Benefits, Timing and Execution

Natural history studies (NHS) in gene therapy trials are essential for understanding the progression of rare diseases and setting appropriate clinical endpoints. These studies provide valuable insights into disease course, help refine trial designs, and prepare for sensitive measurements. Early execution of NHS can significantly improve the success of clinical trials by addressing data gaps and optimizing trial execution. For more details on the importance of NHS in gene therapy, explore the full article