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10/16/2001

Medical Journal Editors Demand Accountability from Study Authors, Sponsors

Kate Traynor

Thirteen major medical journals have adopted a new policy requiring authors to personally vouch for the independence and objectivity of their work before it can be published.

The policy, which addresses conflicts of interest, is an attempt to curb the influence of clinical trial sponsors on the review and interpretation of data and the drafting of research reports. Details about the policy appeared in a joint editorial published in mid-September by editors of the New England Journal of Medicine, Journal of the American Medical Association, nine other medical journals, and MEDLINE.

Clinical studies, said the editors, are increasingly conducted with the goal of marketing products and without seeking to "advance the standard of care." And pharmaceutical companies that previously relied on independent, academic research centers have turned to contract research organizations, which run clinical studies with the goal of speeding the regulatory approval of drugs and medical devices.

These sponsor-controlled settings, said the editors, can mean that researchers "may have little or no input into trial design, no access to raw data, and limited participation in data interpretation." The editors also noted with concern that investigators, instead of publishing their findings, have sometimes "buried" results that did not favor the sponsor’s product.

The editors noted that their criticisms about the objectivity of research are directed not only against pharmaceutical companies but also governmental agencies and any other organization that sponsors clinical studies.

To address these concerns, the new editorial policy requires authors and reviewers to state explicitly whether they do or do not have a potential conflict of interest. Similarly, editors and journal staff members must publicly disclose their potential professional and financial conflicts of interest.

In addition, the editorial affirmed that "a submitted manuscript is the intellectual property of its authors, not the study sponsor." A study’s sponsor, said the editors, "must impose no impediment, direct or indirect, on the publication of the study’s full results, including data perceived to be detrimental to the product."

The editorial policy is being incorporated into the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication," a document produced by the International Committee of Medical Journal Editors.

Although the editorial policy was published in September, rumors of the policy change preceded the editorial’s release by several weeks.

"We were anticipating something profoundly different from the current policy," said American Journal of Health-System Pharmacy Editor C. Richard Talley. "Instead of that, what I believe they’ve shown us is simply an underscoring of what I believe all biomedical peer-reviewed journals try to do."

Talley noted that AJHP has long required authors to acknowledge, in writing, that they take "full public responsibility" for the content of articles submitted to the journal [see the Q&A article in the Nov. 1 issue]. He added, however, that AJHP’s editorial staff has not asked authors to verify the independence and objectivity of their work.

Still, Talley said, it is impossible for editors to establish, absolutely, a conflict of interest. "We’re dependent on the honesty and openness of the author" to disclose any conflicts.

The biggest change in the other editors’ policy, Talley said, is that "they are explicitly singling out reviewers as well as authors." In response, he said, AJHP may alter its communications with reviewers by asking them to disclose any conflicts of interest that could affect their interpretation of an article under review.

"To me, that’s important," Talley said, adding that the reviewers’ disclosures are not as important as getting the authors to reveal biases that preclude objectivity.