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Statistics in Oncology

Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA

Judith Abrams

Karmanos Cancer Institute, Wayne State University, Detroit, MI

Marc Buyse

International Drug Development Institute, Louvain-la-Neuve, Belgium

Richard J. Chappell

Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin, Madison, WI

Every year at the largest statistics conference in the United States, there is a meeting of cancer center biostatisticians. The discussions are lively and each topic strikes a familiar chord. Biostatisticians in every cancer center seem to be facing the same controversies and questions, related to topics such as phase I and II designs, meta-analysis, genomics and molecular characterization of tumors, clinical trials of targeted therapy, adaptive designs, and surrogate markers. These statistics conference discussions raise many interesting points of view, but the meetings end all too soon. There are many current issues that deserve a thoughtful analysis reflecting theoretical depth as well as clinical relevance. It is for this reason that former associate editor, H. Samuel Wieand, proposed that Journal of Clinical Oncology (JCO) create a forum for articles in cancer biostatistics. Unfortunately, Sam would not live to see his proposal implemented in JCO.

In this issue, we launch the exciting new series Sam had in mind: Statistics in Oncology. We hope the articles will be useful both to cancer biostatisticians and to scientists seeking a better understanding of modern methods. They may include the presentation of new methods, the thorough examination of controversies, and timely reviews. The articles will not be "Statistics 101"—presenting well-understood methods at an introductory level. Nor will they have the technical complexity of articles that appear in professional statistics journals.

We begin this series with an interesting and timely article, "Blinded Independent Central Review of Progression-Free Survival in Phase III Clinical Trials: Important Design Element or Unnecessary Expense?" by Lori Dodd and colleagues at the National Cancer Institute (Rockville, MD). Progression-free survival (PFS) as an end point in clinical trials is fraught with difficult questions, one of which regards bias in the progression assessment. PFS is being increasingly promoted with blinded, independent review as a cure-all to such bias. Dodd et al¹ call this proposed solution into question using a relevant example, and discuss possible solutions. This article will be of interest to statisticians and clinical scientists considering PFS as an end point, and will set an excellent example of the type of articles to come in this new series.

We are confident that this initial article and others in this series will generate more interesting discussion as well as resolve issues under debate. We will solicit articles on an ongoing basis, adapting to the current trends. We also welcome contributed papers as long as they fit with the themes we believe are important for the readers of JCO.

We launch this series with gratitude to Sam Wieand, whose ideas continue to inspire us.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

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

AUTHOR CONTRIBUTIONS

Conception and design: Stephanie R. Land

Manuscript writing: Stephanie R. Land, Judith Abrams, Marc Buyse, Richard J. Chappell

Final approval of manuscript: Stephanie R. Land, Judith Abrams, Marc Buyse, Richard J. Chappell

REFERENCE

1. Dodd LE, Korn EL, Freidlin B, et al: Blinded independent central review of progression-free survival in phase III clinical trials: Important design element or unnecessary expense? J Clin Oncol 26:3791-3796, 2007

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