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. 2002 Nov 2;325(7371):985.

Better standards needed for industry sponsored clinical trials

Janice Hopkins Tanne 1
PMCID: PMC1124541

Three papers in the New England Journal of Medicine highlight problems of academic freedom and scientific integrity in agreements between medical schools and industry sponsors who pay for many clinical trials.

Agreements between industry and medical schools fall far short of the guidelines of the International Committee of Journal Editors and the Association of American Colleges, says a new survey .

Researchers from Duke University, in Durham, North Carolina, asked administrators at 108 US medical schools about their agreements with industry, looking at bias that might result from the sponsor's role in designing the study, as well as investigators' access to data and sponsors' control of publication of trial results.

Medical schools are offered contracts that are “close to take it or leave it,” said the survey's lead author, Dr Kevin Schulman, of the Center for Clinical and Genetic Economics, Duke University Medical Center. If an institution tries to negotiate better terms, the sponsor simply asks another school to participate.

In an accompanying editorial Dr Jeffrey Drazen, the journal's editor in chief, writes, “It is imperative that the terms of such contracts guarantee the safety and confidentiality of patients while preserving the academic independence of participating investigators” (2002; 347:1362-3).

Partnership between industry and academia will lead to clinical advances only if academic freedom is preserved, says a commentary that reviews the case of Canadian researcher Dr Nancy Olivieri, who was sued after she presented unfavourable results of a drug trial for which she had signed a confidentiality agreement. An independent external review panel, perhaps established by a national research council, might mediate such scientific disagreements, the commentary says (2002;347:1368-71).


Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Publishing Group

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