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Editorial
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Volume 358:1850-1851 April 24, 2008 Number 17
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Full Disclosure and the Funding of Biomedical Research
Robert S. Schwartz, M.D., Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.

 

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Clinical studies have become very expensive to conduct, and multiple sources of funding often support a single study. Biomedical journals routinely disclose all sources of funding of the research they publish; this has been standard practice at the Journal for many years. As funding mechanisms grow increasingly complex, however, it has become ever more challenging for editors to ensure the complete reporting of all sources of financial support.

Why is this important? Although the science in a submitted manuscript should be judged on its merits, one cannot fully appreciate a study's meaning without acknowledging the subtle biases in design and interpretation that may arise when a sponsor stands to gain from the report. Because of these subtleties, it is especially important that any such associations be made clear to the Journal's readers, who can then judge their relevance for themselves.

Recent years have seen the creation of nonprofit foundations housed at academic institutions but organized for the benefit of individual investigators and funded by industry sponsors. Such foundations may on the one hand be helpful in providing needed research funds at a time when there are constraints on funding from the National Institutes of Health, especially for clinical trials. On the other hand, such foundations may not be required to publicly disclose the details of their own funding sources and expenditures. Thus, editors, reviewers, and readers are left in the dark about the actual sources of support for a research project.

In October 2006 we published an article by the Lung Cancer Screening Group1 in which computed tomographic (CT) scanning was used to screen a high-risk population for evidence of early-stage lung cancer. From the data they gathered, the authors concluded that the majority of stage I lung cancers treated after their detection by CT screening had a favorable prognosis.

The Lung Cancer Screening Group's research was funded by 32 different entities, one of which was the Foundation for Lung Cancer: Early Detection, Prevention and Treatment. It has not been our practice to inquire about the specific sources of funding of foundations such as this. We recently learned, however, that this foundation was headed by the principal investigator of the 2006 study, that it was housed at her academic institution, and that the only contributor during most of its existence was the Vector Group, the parent company of Liggett, a major tobacco company. We and our readers were surprised to learn that the source of the funding of the charitable foundation was, in fact, a large corporation that could have an interest in the study results.

This situation raises two concerns. First, as medical journal editors, we believe that it is important that the ultimate source of funding be made clear to the Journal's readers. Second, it is appropriate to ask whether a study on clinical outcomes in lung cancer should be directly underwritten in part by the tobacco industry. Given the enormous burden of smoking-related illness and the ongoing sale of cigarettes and other forms of tobacco, one might question the advisability of research entities accepting funding from tobacco companies except through the American Legacy Foundation, which distributes funds received through the Master Settlement Agreement with U.S. tobacco companies.

We believe that it is important for our readers and the entire biomedical community to be aware of this situation. Our goal is that readers be fully informed about funding sources. It is the responsibility of authors to disclose fully and appropriately the sources of funding of their studies. We expect that authors will be particularly attentive to transparency in reporting if a funding entity has a vested interest in the outcome. The public's trust in biomedical research depends on it.


Source Information

This article (10.1056/NEJMe0802618) was published at www.nejm.org on April 2, 2008.

References

  1. The International Early Lung Cancer Action Program Investigators. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med 2006;355:1763-1771. [Free Full Text]

 

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Related Letters:

Clarification of Funding of Early Lung Cancer Study
Henschke C.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:1862, Apr 24, 2008; published at www.nejm.org on Apr 2, 2008 (10.1056/NEJMc086128). Correspondence

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