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REPLY

Sponsorship, Authorship, and Accountability

right arrow International Committee of Medical Journal Editors

5 February 2002 | Volume 136 Issue 3 | Page 252


IN RESPONSE:

Mr. Holmer (for the Pharmaceutical Research and Manufacturers of America) presents one pole in the debate over studies funded by industry and performed by academics. Academic investigators and industrial sponsors both contribute to the accrual of new medical knowledge. An appropriate balance is struck when a novel treatment can be tested in an environment in which all data are freely available to all investigators. When a report is prepared for publication, the primary goal must be the fair, honest, accurate, and complete dissemination of the accrued information. The system is best served when there is no attempt to present the study results in a more favorable light by selectively reporting the data.

The CRO Consortium argues that CROs have an auxiliary function in the performance of clinical trials and that CROs do not compete with academic investigators. We did not wish to diminish the role of CROs; these organizations provide substantial benefit with respect to the orderly accrual of complex clinical research data sets. However, CROs act as agents for the sponsor, not the investigator. When a sponsor does not want to deal with an investigator, the CRO may provide just enough separation to make such discrimination easy.

About Letters
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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 Unpublished letters cannot be returned.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.


Related articles in Annals:

Editorials
Sponsorship, Authorship, and Accountability
Frank Davidoff, Catherine D. DeAngelis, Jeffrey M. Drazen, The Editors, John Hoey, Liselotte Højgaard, Richard Horton, Sheldon Kotzin, Magne Nylenna, A. John P.M. Overbeke, Harold C. Sox, Martin B. Van Der Weyden, AND Michael S. Wilkes
Annals 2001 135: 463-466. [Full Text]  

Letters
Sponsorship, Authorship, and Accountability
Alan F. Holmer
Annals 2002 136: 251. [Full Text]  

Letters
Sponsorship, Authorship, and Accountability
Covance Inc., ICON Clinical Research, Inveresk Research Group, Kendle International Inc., PAREXEL International Corp., PPD Development, AND Quintiles Transnational Corp.
Annals 2002 136: 251-252. [Full Text]  



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