Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

Author:

Lee Eudocia Q12,Weller Michael3ORCID,Sul Joohee4,Bagley Stephen J5,Sahebjam Solmaz6,van den Bent Martin7,Ahluwalia Manmeet8,Campian Jian L9,Galanis Evanthia10,Gilbert Mark R11,Holdhoff Matthias12,Lesser Glenn J13,Lieberman Frank S14,Mehta Minesh P15,Penas-Prado Marta11,Schreck Karisa C12,Strowd Roy E13,Vogelbaum Michael A6,Walbert Tobias16,Chang Susan M17,Nabors L Burt18,Grossman Stuart12,Reardon David A12,Wen Patrick Y12

Affiliation:

1. Dana-Farber Cancer Institute, Boston, Massachusetts, USA

2. Harvard Medical School, Boston, Massachusetts, USA

3. University Hospital and University of Zurich, Zurich, Switzerland

4. Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA

5. Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA

6. Moffitt Cancer Center, Tampa, Florida, USA

7. Erasmus University Hospital, Rotterdam, Netherlands

8. Cleveland Clinic, Cleveland, Ohio, USA

9. Washington University, St Louis, Missouri, USA

10. Mayo Clinic, Rochester, Minnesota, USA

11. Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA

12. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, USA

13. Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, USA

14. University of Pittsburgh, Pittsburgh, Pennsylvania, USA

15. Miami Cancer Institute, Miami, Florida, USA

16. Henry Ford Health System, Detroit, Michigan, USA

17. University of California San Francisco, San Francisco, California, USA

18. University of Alabama at Birmingham, Birmingham, Alabama, USA

Abstract

AbstractBuilding on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

Funder

Adult Brain Tumor Consortium

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Clinical Neurology,Oncology

Cited by 34 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3