Basket trial designs in oncology: A comprehensive systematic review.

IF 1.9 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Clinical and Experimental Medicine Pub Date : 2025-09-04 DOI:10.17219/acem/204832

Mikołaj Bartoszkiewicz, Joanna Kufel-Grabowska, Paweł Burchardt

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引用次数: 0

Abstract

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.

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肿瘤学一揽子试验设计：一项全面的系统回顾。

背景：篮子试验是一种创新类型的临床试验，主要用于肿瘤学。这些研究的一个显著特点是根据特定的分子特征（如基因突变或免疫亚型）对患者进行分组，而不是根据癌症类型等传统标准。材料和方法：本综述按照系统评价和荟萃分析的首选报告项目（PRISMA）指南进行。医学数据库检索了2014年至2024年间发表的研究。纳入标准侧重于作为肿瘤学临床试验模型的篮子试验。目的：本工作旨在概述在肿瘤学中进行篮子试验的原则，分析过去十年的篮子试验，并强调这类试验的新趋势。结果：对76篇符合纳入标准的文章的分析显示，这些研究大部分为II期临床试验。分析中篮子试验的平均持续时间为5.9年（平均= 5.05），平均招募目标为326例患者（平均= 123.5）。这些研究大多是在美国进行的，大多数篮子试验集中在实体瘤患者身上。结论：系统评价证实了篮子试验作为一种临床试验模式具有显著的潜力，越来越多的篮子试验项目正在进行。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Clinical and Experimental Medicine MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

3.70

自引率

4.80%

发文量

153

审稿时长

6-12 weeks

期刊介绍： Advances in Clinical and Experimental Medicine has been published by the Wroclaw Medical University since 1992. Establishing the medical journal was the idea of Prof. Bogumił Halawa, Chair of the Department of Cardiology, and was fully supported by the Rector of Wroclaw Medical University, Prof. Zbigniew Knapik. Prof. Halawa was also the first editor-in-chief, between 1992-1997. The journal, then entitled "Postępy Medycyny Klinicznej i Doświadczalnej", appeared quarterly. Prof. Leszek Paradowski was editor-in-chief from 1997-1999. In 1998 he initiated alterations in the profile and cover design of the journal which were accepted by the Editorial Board. The title was changed to Advances in Clinical and Experimental Medicine. Articles in English were welcomed. A number of outstanding representatives of medical science from Poland and abroad were invited to participate in the newly established International Editorial Staff. Prof. Antonina Harłozińska-Szmyrka was editor-in-chief in years 2000-2005, in years 2006-2007 once again prof. Leszek Paradowski and prof. Maria Podolak-Dawidziak was editor-in-chief in years 2008-2016. Since 2017 the editor-in chief is prof. Maciej Bagłaj. Since July 2005, original papers have been published only in English. Case reports are no longer accepted. The manuscripts are reviewed by two independent reviewers and a statistical reviewer, and English texts are proofread by a native speaker. The journal has been indexed in several databases: Scopus, Ulrich’sTM International Periodicals Directory, Index Copernicus and since 2007 in Thomson Reuters databases: Science Citation Index Expanded i Journal Citation Reports/Science Edition. In 2010 the journal obtained Impact Factor which is now 1.179 pts. Articles published in the journal are worth 15 points among Polish journals according to the Polish Committee for Scientific Research and 169.43 points according to the Index Copernicus. Since November 7, 2012, Advances in Clinical and Experimental Medicine has been indexed and included in National Library of Medicine’s MEDLINE database. English abstracts printed in the journal are included and searchable using PubMed http://www.ncbi.nlm.nih.gov/pubmed.