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Anesth Analg 2007; 105:1861-1862
© 2007 International Anesthesia Research Society
doi: 10.1213/01.ane.0000287631.83502.1d
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LETTER TO THE EDITOR

Section Editor:
Lawrence Saidman

The Importance of Transparency in Industry-Sponsored Multicenter Clinical Studies

Tong J. Gan, MD, Christian C. Apfel, MD, PhD, Anthony Kovac, MD, Beverly K. Philip, MD, Neil Singla, MD, PhD, Harold Minkowitz, MD, Ashraf S. Habib, MBBCh, MSc, FRCA, Alexandra Carides, PhD, Kevin J. Horgan, MD, Judith K. Evans, MD, and Francesca C. Lawson, MD

Department of Anesthesiology; Duke University Medical Center; Durham, NC; gan00001{at}mc.duke.edu (Gan) Perioperative Clinical Research Core; Department of Anesthesia and Perioperative Care; University of CA San Francisco Medical Center at Mount Zion; San Francisco, CA (Apfel) University of Kansas Medical Center; Kansas City, KS (Kovac) Department of Anesthesiology; Perioperative and Pain Medicine; Brigham and Women’s Hospital; Boston, MA (Philip) Huntington Memorial Hospital; Clinical Management Services, Inc.; Pasadena, CA (Singla) Memorial Hermann Memorial City Hospital; Houston, TX (Minkowitz) Duke University Medical Center; Durham, NC (Habib) Merck Research Laboratories; North Wales, PA (Carides, Horgan, Evans, Lawson)

In Response:

We appreciate the opportunity to respond to the letter (1) concerning the article by Gan et al. (2) on aprepitant for prevention of postoperative nausea and vomiting. There are a number of points in this letter that require clarification.

Data quality management and analyses were conducted by the sponsor. The decision to exclude efficacy data from a single study site was made by the sponsor before unblinding, based upon a thorough, standard, objective audit in accordance with the obligation of sponsors as outlined in the Code of Federal Regulations, 21CFR312.56 (http://www.gpoaccess.gov/cfr/index.html). Analyses of the primary endpoint with and without the excluded site were outlined before study unblinding. These were performed concurrently at the time of the initial analysis and before the submission of the manuscript for publication, and were submitted to FDA along with the Supplemental New Drug Application. Inclusion or exclusion of data from the site did not influence the study results. The original submitted draft of the article explained what data were excluded, and why. There has been no lack of transparency. All authors believe that appropriate procedures were followed.

Consistent with the requirements of International Committee of Medical Journal Editors (http://www.icmje.org), the authors of the paper were offered the opportunity to review the data at the sponsor’s data repository. The primary author reviewed the data and was satisfied with its integrity, as well as the appropriateness of the analyses.

Named authors reviewed the manuscript. The intent behind listing "Aprepitant-PONV Study Group" on the byline was to acknowledge the efforts of the entire group involved in performing the study; nonnamed members of the group were not authors and did not review the paper.

We must emphasize our firm belief in adherence to the principles of collaboration, integrity of the peer-review process, accuracy of scientific measurements, and transparent reporting of clinical trial results.

REFERENCES

  1. White PF. The importance of transparency in industry-sponsored multicenter clinical studies. Anesth Analg 2007;105: 1861[Free Full Text]
  2. Gan TJ, Apfel CC, Kovac A, Philip BK, Singla N, Minkowitz H, Habib AS, Knighton J, Carides AD, Zhang H, Horgan KJ, Evans JK, Lawson FC. Aprepitant-PONV Study Group. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg 2007;104:1082–9[Abstract/Free Full Text]




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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press