Originally published as JCO Early Release 10.1200/JCO.2009.23.8675 on June 22 2009

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Reply to C.D. Atkins

Biometric Research Branch and Clinical Investigations Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD

Dr Atkins¹ does not fully represent our conclusions with his quotation from the Discussion of our article.² The full quotation is: "Concerns about biased treatment effects as a result of the early stopping are statistically valid but may not be practically important; the bias may not be much larger than would be seen for a positive trial not stopped early, and releasing information early about an effective treatment may be more important than knowing the exact magnitude of the benefit. However, concerns about early stopping/release limiting the ability to estimate long-term survival curves (and potentially identify crossing hazards) or to estimate OS [overall survival] curves (when the stopping is based on a non-OS end point) are statistically valid and practically important." We believe that Atkins would agree with the full quotation. In addition, Atkins cites a single prevention randomized trial, whereas our article provided a systematic review that explicitly evaluated all relevant treatment randomized trials; it is important to perform a comprehensive review of a well-defined set of trials if one is to assess clinical trial methodology.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

REFERENCES

1. Atkins CD: Stopping trials early for positive results: The need to know how much. J Clin Oncol 27:e29; 2009.[Free Full Text]

2. Korn EL, Freidlin B, 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 27:1712–1721, 2009.[Abstract/Free Full Text]

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• Stopping Trials Early for Positive Results: The Need to Know How Much
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Related Correspondence

• Stopping Trials Early for Positive Results: The Need to Know How Much
  Carl D. Atkins
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This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Google Scholar Articles by Korn, E. L. Articles by Mooney, M. PubMed PubMed Citation Articles by Korn, E. L. Articles by Mooney, M. Related Articles Related Article Related Correspondence Social Bookmarking                            What's this?