Cancer registries: a novel alternative to long-term clinical trial follow-up based on results of a comparative study

Author:

Qian Shi 1,You Y Nancy2,Nelson Heidi2,Allen Mark S3,Winchester David4,Stewart Andrew4,Young-Fadok Tonia5,Decker Paul A6,Green Erin M6,Holton Sara J7,Ballman Karla V6

Affiliation:

1. Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA,

2. Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN, USA

3. Division of General Thoracic Surgery, Mayo Clinic, Rochester, MN, USA

4. National Cancer Database, American College of Surgeons, Chicago, IL, USA

5. Department of Surgery, Mayo Clinic, Scottsdale, AZ, USA

6. Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA

7. Health Information Management Services, Mayo Clinic, Rochester, MN, USA

Abstract

Background Data collection and review were identified as major contributors to the cost of randomized clinical trials (RCTs). Purpose We proposed and assessed a novel alternative for long-term clinical trial follow-up based on the data captured through an accredited Cancer Registry (CR) that is part of the National Cancer Database (NCDB). Methods Patients from Mayo Clinic, Rochester, enrolled in the North Central Cancer Treatment Group N934653 (COST) trial (98 patients) and the American College of Surgeons Oncology Group Z0030 trial (55 patients) were included in the study. Demographic, treatment, and long-term outcome data were compared between the hospital-based CR and the RCTs’ databases. Concordances were used to estimate the agreement between two databases. Kaplan—Meier curves were plotted to examine the consistency of time-to-event long-term outcomes of the CR and RCT databases. Results High concordances (>95%) were observed for most demographic and treatment variables between the CR data and RCT data. The vital status concordances were 100% and 94.5% between the CR and COST and Z0030 databases, respectively. Three discrepant death dates were observed, one in the COST trial and two in the Z0030 trial. The concordances of disease-free status between the CR and RCT databases were 99.0% and 87.3%, and 15 discrepant disease recurrence cases were identified: 4 for COST and 11 for Z0030. Limitations The analysis has been focused on patients from a single site, Mayo Clinic, Rochester, enrolled in two large RCT evaluating surgical treatments. The findings herein need to be confirmed in a broader setting, such as multi-center, multi-registry including nonsurgical trials. Conclusions CR data were nearly identical to data from two randomized phase III trials in different disease types and conducted by two different cooperative groups. The NCDB Cancer Registries represent a feasible alternative for obtaining long-term follow-up data for large clinical trials. Clinical Trials 2010; 7: 686—695. http:// ctj.sagepub.com

Publisher

SAGE Publications

Subject

Pharmacology,General Medicine

Reference8 articles.

1. The Costs of Conducting Clinical Research

2. Improving the Quality of Cancer Clinical Trials Workshop Summary , Institute of Medicine, 2008. Available at: http://www.iom.edu/en/Reports/2008/Improving-the-Quality-of-Cancer-Clinical-Trials-Workshop-Summary.aspx (accessed 7 December 2009).

3. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary, Institute of Medicine, 2009 . Available at: http://www.iom.edu/en/Reports/2009/Multi-Center-Phase-III-Clinical-Trials-and-NCI-Cooperative-Groups-Workshop-Summary.aspx (accessed 7 December 2009).

4. The National Cancer Data Base: A Powerful Initiative to Improve Cancer Care in the United States

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