Basket trial designs in oncology: A comprehensive systematic review.

[BACKGROUND] Basket trials are an innovative type of clinical trial primarily used in oncology. A distinctive feature of these studies is the grouping of patients based on specific molecular characteristics, such as genetic mutations or immunological subtypes, rather than traditional criteria like the type of cancer.

[MATERIAL AND METHODS] This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Medical databases were searched for studies published between 2014 and 2024. The inclusion criteria focused on basket trials as a clinical trial model in oncology.

[OBJECTIVES] This work aims to outline the principles of conducting basket trials in oncology, analyze basket trials from the past decade, and highlight the emerging trends in this type of trial.

[RESULTS] The analysis of 76 articles meeting the inclusion criteria revealed that most of these studies are conducted as phase II clinical trials. The average duration of the basket trials in the analysis was 5.9 years (mean = 5.05), with an average recruitment target of 326 patients (mean = 123.5). Most of these studies were conducted in the USA, and the majority of basket trials focused on patients with solid tumors.

[CONCLUSION] The systematic review confirms that basket trials have significant potential as a clinical trial model, as evidenced by the increasing number of basket trial projects being conducted.