Impartial Audit of Research Data Is Needed, Says Editor of "The Oncologist"
DURHAM, N.C., Oct. 1 /PRNewswire/ -- In response to new concerns about a study supporting the use of computed tomography (CT) screening to detect early-stage lung cancer in smokers and other people at risk, the Editor-in-Chief of "The Oncologist" has called for an independent audit of the research data.
" ... the results of this key lung cancer prevention trial, heralded as evidence for the value of CT screening for lung cancer, have become increasingly ambiguous, a situation that can be dispelled only by auditing the trial," writes Dr. Bruce A. Chabner in an editorial.
Controversy has emerged regarding the International Early Lung Cancer Action Project (I-ELCAP) study, originally published in The New England Journal of Medicine in 2006. Lead researcher Dr. Claudia Henschke of Weill Medical College of Cornell University, New York, concluded that annual CT screening improves the chances of survival for patients with early-stage lung cancer.
Dr. Henschke believes her findings support annual CT scans for early detection of lung cancer in people at increased risk -- especially smokers. She has stood by her conclusions in the face of controversies regarding errors in patient enrollment, her undisclosed relationship with a major CT manufacturer, and the revelation that the study was partially funded by a tobacco company.
Dr. Chabner's call for an audit is prompted by a letter to the editor by Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center, New York, also published by "The Oncologist." Dr. Bach points out an apparent irregularity in the way the I-ELCAP researchers calculated the survival benefit of CT screening. Specifically, while the original 2006 paper included data on eight "untreated subjects" who died of lung cancer, subsequent reports have included thirteen such patients.
Dr. Bach also raises concerns regarding the follow-up for some of the patients, noting that it was a virtual statistical impossibility that Henschke had the findings that she published. Dr. Bach comments, "I am concerned that there may have been an error during the analysis of the trial, such that the apparent benefit of screening appeared larger than it is."
In a published reply, Dr. Henschke writes that the discrepancy occurred because some patients were originally "misclassified," and that this error was perpetuated in follow-up analyses.
Dr. Chabner has previously urged a re-evaluation of the I-ELCAP data, and reiterates his call in response to the new concerns. He writes, "The bond that clinical investigators make with cancer patients who volunteer their enrollment is sacred ... Given the confusion that reigns, only with a thorough, complete, and impartial audit can this bond, the cornerstone of clinical research, be restored and preserved."
Dr. Thomas J. Lynch, Director of the Center for Thoracic Cancers at Massachusetts General Hospital, agrees that an independent audit is needed. "Finding out if screening CT scans save lives from lung cancer is of urgent importance," he comments. "Millions of ex-smokers await guidance on the use of this technology and it is tragic that we do not have more clarity on this crucial issue."
Dr. Chabner's editorial, Dr. Bach's letter and Dr. Henschke's reply,
published by "The Oncologist," are freely available:
Dr. Chabner editorial:
Dr. Bach Letter to Editor:
Dr. Henschke Response:
About AlphaMed Press
AlphaMed Press publishes the internationally renowned journals, "Stem Cells" and "The Oncologist." "Stem Cells," now in its 26th year, is the oldest and one of the world's top-tier peer-reviewed monthly journals in the fast-paced area of stem cells and regenerative medicine. "The Oncologist," in its 13th year, is a premier peer-reviewed monthly journal dedicated to physicians entrusted with the care of cancer patients. View AlphaMed Press journals at http://www.alphamedpress.org.
Contact: Dr. Martin J. Murphy, Executive Editor: 919.402.8750, Martin.Murphy@TheOncologist.com
|SOURCE AlphaMed Press|
Copyright©2008 PR Newswire.
All rights reserved