Skip to main content

Main menu

  • Home
  • Content
    • Current
    • Ahead of print
    • Archive
  • Info for
    • Authors
    • Reviewers
  • About Us
    • About the Ochsner Journal
    • Editorial Board
  • More
    • Alerts
    • Feedback
  • Other Publications
    • Ochsner Journal Blog

User menu

  • My alerts
  • Log in

Search

  • Advanced search
Ochsner Journal
  • Other Publications
    • Ochsner Journal Blog
  • My alerts
  • Log in
Ochsner Journal

Advanced Search

  • Home
  • Content
    • Current
    • Ahead of print
    • Archive
  • Info for
    • Authors
    • Reviewers
  • About Us
    • About the Ochsner Journal
    • Editorial Board
  • More
    • Alerts
    • Feedback
Research ArticleArticle

Bioethics in Practice: Considerations for Stopping a Clinical Trial Early

Richard E. Deichmann, Marie Krousel-Wood and Joseph Breault
Ochsner Journal September 2016, 16 (3) 197-198;
Richard E. Deichmann
1Department of Internal Medicine, Ochsner Clinic Foundation, New Orleans, LA
2The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA
MD
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Marie Krousel-Wood
3Department of Medicine, Tulane University School of Medicine, Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA and Research Division, Ochsner Clinic Foundation, New Orleans, LA
MD, MSPH
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Joseph Breault
2The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA
4Department of Family Medicine and Institutional Review Board Chair, Ochsner Clinic Foundation, New Orleans, LA
MD
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • References
  • Info & Metrics
  • PDF
Loading

REFERENCES

  1. ↵
    1. Wright JT Jr.,
    2. Williamson JD,
    3. Whelton PK
    SPRINT Research Group Wright JT Jr., Williamson JD, Whelton PK et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med. 2015 11 26; 373 22: 2103- 2116. doi: 10.1056/NEJMoa1511939. pmid:26551272
    OpenUrlCrossRefPubMed
  2. ↵
    1. Bassler D,
    2. Briel M,
    3. Montori VM,
    4. et al.
    Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 2010 3 24; 303 12: 1180- 1187. doi: 10.1001/jama.2010.310. pmid:20332404
    OpenUrlCrossRefPubMedWeb of Science
    1. Korn EL,
    2. Freidlin B,
    3. Mooney M.
    Bias and trials stopped early for benefit. JAMA. 2010 7 14; 304 2: 157- 158 ; author reply 158-159. doi: 10.1001/jama.2010.932. pmid:20628125
    OpenUrlCrossRefPubMed
    1. Ellenberg SS,
    2. DeMets DL,
    3. Fleming TR.
    Bias and trials stopped early for benefit. JAMA. 2010 Jul 14; 304 2: 158; author reply 158-159 doi: 10.1001/jama.2010.933. pmid:20628127
    OpenUrlCrossRefPubMed
    1. Goodman S,
    2. Berry D,
    3. Wittes J.
    Bias and trials stopped early for benefit. JAMA. 2010 Jul 14;304(2):157; author reply 158-159. doi: 10.1001/jama.2010.931.
  3. ↵
    1. Korn EL,
    2. Freidlin B,
    3. Mooney M.
    Stopping or reporting early for positive results in randomized clinical trials: the National Cancer Institute Cooperative Group experience from 1990 to 2005. J Clin Oncol. 2009 4 1; 27 10: 1712- 1721. doi: 10.1200/JCO.2008.19.5339. pmid:19237631
    OpenUrlAbstract/FREE Full Text
  4. ↵
    1. Dahlöf B,
    2. Sever PS,
    3. Poulter NR,
    4. et al.
    ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005 9 10-16; 366 9489: 895- 906. pmid:16154016
    OpenUrlCrossRefPubMedWeb of Science
  5. ↵
    1. Zannad F,
    2. McMurray JJ,
    3. Krum H,
    4. et al.
    EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 1 6; 364 1: 11- 21. doi: 10.1056/NEJMoa1009492. pmid:21073363
    OpenUrlCrossRefPubMedWeb of Science
  6. ↵
    1. Cleophas TJ,
    2. Zwinderman AH.
    Statistics Applied to Clinical Studies. 5th ed. Dordrecht, Netherlands: Springer Science+Business Media BV; 2012.
  7. ↵
    1. Pocock SJ.
    When to stop a clinical trial. BMJ. 1992 7 25; 305 6847: 235- 240. pmid:1392832
    OpenUrlFREE Full Text
  8. ↵
    US Food and Drug Administration Institutional Review Boards. FDA: 21 CFR §56.111 . April 1, 2015 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.111. Accessed June 3, 2016.
  9. ↵
    1. Chan S.
    6 hospitalized, one of them brain-dead, after drug trial in France. The New York Times . January 15, 2016 http://www.nytimes.com/2016/01/16/world/europe/french-drug-trial-hospitalization.html?_r=0. Accessed June 1, 2016.
  10. ↵
    1. Fidler B.
    Verastem sinks as mesothelioma study halted for futility. Exome . September 28, 2015 http://www.xconomy.com/boston/2015/09/28/verastem-sinks-as-mesothelioma-study-halted-for-futility/#. Accessed June 1, 2016.
  11. ↵
    1. Zannad F,
    2. Gattis Stough W,
    3. McMurray JJ,
    4. et al.
    When to stop a clinical trial early for benefit: lessons learned and future approaches. Circ Heart Fail. 2012 3 1; 5 2: 294- 302. doi: 10.1161/CIRCHEARTFAILURE.111.965707. pmid:22438522
    OpenUrlFREE Full Text
  12. ↵
    1. Cannistra SA.
    The ethics of early stopping rules: who is protecting whom? J Clin Oncol. 2004 5 1; 22 9: 1542- 1545. pmid:15117977
    OpenUrlFREE Full Text
PreviousNext
Back to top

In this issue

Ochsner Journal
Vol. 16, Issue 3
Sep 2016
  • Table of Contents
  • Index by author
Print
Download PDF
Email Article

Thank you for your interest in spreading the word on Ochsner Journal.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Bioethics in Practice: Considerations for Stopping a Clinical Trial Early
(Your Name) has sent you a message from Ochsner Journal
(Your Name) thought you would like to see the Ochsner Journal web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Bioethics in Practice: Considerations for Stopping a Clinical Trial Early
Richard E. Deichmann, Marie Krousel-Wood, Joseph Breault
Ochsner Journal Sep 2016, 16 (3) 197-198;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Bioethics in Practice: Considerations for Stopping a Clinical Trial Early
Richard E. Deichmann, Marie Krousel-Wood, Joseph Breault
Ochsner Journal Sep 2016, 16 (3) 197-198;
del.icio.us logo Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • REFERENCES
  • References
  • Info & Metrics
  • PDF

Cited By...

  • Exploring scalable assessment methods for terminated trials in ClinicalTrials.gov: A cohort analysis of German and Californian trials
  • Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
  • Google Scholar

More in this TOC Section

  • Letters to the EditorBeware of Right Renal Vein Valves in Transplanted Kidneys: Renal Vein Valvuloplasty in a Donor KidneySeizure Caused by Tumor Necrosis Factor-Alpha Inhibitor-Induced Central Nervous System DemyelinationPositron Emission Tomography-Positive Pleural-Based Nodule Following Talc Pleurodesis
  • From the Editor's Desk: A Focus on Organ Transplantation
  • Clinical Images: Interventional Management of Pediatric Rex Shunt Stenosis
Show more Article

Similar Articles

Our Content

  • Home
  • Current Issue
  • Ahead of Print
  • Archive
  • Featured Contributors
  • Ochsner Journal Blog
  • Archive at PubMed Central

Information & Forms

  • Instructions for Authors
  • Instructions for Reviewers
  • Submission Checklist
  • FAQ
  • License for Publishing-Author Attestation
  • Patient Consent Form
  • Submit a Manuscript

Services & Contacts

  • Permissions
  • Sign up for our electronic table of contents
  • Feedback Form
  • Contact Us

About Us

  • Editorial Board
  • About the Ochsner Journal
  • Ochsner Health
  • University of Queensland-Ochsner Clinical School
  • Alliance of Independent Academic Medical Centers

© 2026 Ochsner Clinic Foundation

Powered by HighWire