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Zafirlukast in Asthma
- Peter K. Honig, MD;
- Raymond Anthracite, MD; and
- John K. Jenkins, MD
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
TO THE EDITOR:
Suissa and colleagues' article [1] illustrates potential limitations of peer review in evaluating manuscripts submitted for publication. It also reinforces the importance of a priori designation of the primary end points and statistical methods to be used in the conduct and analysis of randomized, controlled clinical trials.
Zafirlukast was approved by the U.S. Food and Drug Administration (FDA) on 26 September 1996 for prophylaxis and long-term treatment of asthma [2]. This approval was based, in part, on the results of the large, prospective, placebo-controlled trial (study 0029) [3] that is referenced in Suissa and colleagues' article and within which the authors' investigation was conducted as a nested study. Study 0029 was designed with explicit predefined primary and secondary end points and was analyzed with prespecified statistical rules and procedures.
As Suissa and colleagues stated, their study was conducted as a subprotocol to this larger study. Although Suissa and colleagues' study used standardized data collection forms, the protocol submitted to the FDA was regarded by Zeneca Pharmaceuticals as “exploratory” and as such contained no prespecified primary end point or explicit statistical methods for analyzing the results. These are critical elements for reducing bias in the conduct, analysis, and reporting of clinical trials and raise the issue of the limitations of peer review in assessing clinical trial reports [4]. For example, Suissa and colleagues describe selected analyses as “significant” on the basis of inferential statistical tests that are inappropriate tools to apply to retrospectively defined comparisons. Without having the study protocol to review, peer reviewers and editors do not know whether manuscripts submitted for publication report planned comparisons of prospectively defined end points or the results of exploratory data analyses. We believe that the results of the study should be considered as hypothesis-generating and that confirmation in additional prospective, well-controlled trials is needed.
Peter K. Honig, MD
Raymond Anthracite, MD
John K. Jenkins, MD
U.S. Food and Drug Administration; Rockville, MD 20857
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
- Copyright ©2004 by the American College of Physicians
