Materials and methods The study examined clinical trials on anticancer drugs published between January 1997 and October 2007 that included an interim analysis, retrieved via Medline. The search criteria focused on publications containing the terms "interim" and "analys*" limited to human studies, clinical trials, cancer, and in English. A total of 231 reports were identified. To ensure comprehen...

Objective This study aimed to evaluate the use of interim analyses in randomized controlled trials (RCTs) for testing new anticancer drugs, with a particular focus on oncology trials that were discontinued early due to positive results. Interim analyses are a standard part of clinical trial design, providing an opportunity to evaluate the early efficacy or safety of a treatment before completin...

BACKGROUND Evolving Regulatory Pathways and Ethical Challenges in Accelerated Cancer Drug Approvals Recent updates to European pharmaceutical regulations have introduced accelerated and conditional approval pathways for marketing authorization, largely modeled after the U.S. Food and Drug Administration (FDA)’s expedited programs such as Accelerated Approval and Breakthrough Therapy Designatio...

  Abstract Background With an emphasis on oncological clinical trials that were terminated early for benefit, the study's objective is to evaluate the application of interim analysis in RCTs evaluating novel anticancer medications. Materials and methods Every published clinical study that used anticancer medications and included an interim anal...