According to the National Cancer Institute (Bethesda, Maryland), an estimated 1.9 million new cancer cases and 0.6 million cancer-related deaths are projected in the United States in 2023. Clinical trials represent a critical and final stage in the process of introducing a new drug or medical device to human patients. However, the overall success rate of clinical trials in the modern era is notably low, with an estimated success rate for bringing a new cancer treatment from initial development to U.S. Food and Drug Administration (Silver Spring, Maryland) approval standing at only 3 to 5%.1 Various factors can contribute to the failure of a clinical trial, and these factors may vary depending on its phase. Inadequately validated targets, safety concerns, challenges in patient recruitment and retention, and suboptimal study design are among the issues that can affect the success of clinical trials.
In a review authored by two anesthesiologists,...