Medicare May Reward Drug Trials That Skip Registration

Medicare may add over a half dozen medical journals to the list of publications that determine reimbursement for the off-label use of anti-cancer drugs. None of the proposed journals requires registration of clinical trials prior to publication, and several don't guarantee that they will publish conflict-of-interest disclosures, according to a Center for Science in the Public Interest survey.

Since 1994, Medicare has paid for non-Food and Drug Administration-approved uses of anti-cancer drugs, but only after studies published in an acceptable peer-reviewed journal report that the protocols prolong patients' lives, significantly reduce tumor size or reduce symptoms related to the tumor. The Center for Medicare and Medicaid Services (CMS) currently lists 15 acceptable journals. The American Society for Clinical Oncology (ASCO), which represents over 20,000 oncologists, last May petitioned the agency to add eight more journals to the list, most of them highly specialized.

The CMS notice seeking comment says the agency will only put journals on the list if they use rigorous peer-review, lack publication bias, and require full and timely public disclosure of potential conflicts of interest of authors, reviewers and editors. Registration of clinical trials helps eliminate publication bias by allowing reviewers to compare the results submitted to the journal to the trial's original protocols. Legislation requiring universal, mandatory registration of clinical trials including trial results, which has been introduced in Congress, would enable Medicare and other insurers to compare published trials to any unpublished trial results before they authorize payment for those protocols.

A CSPI review of author guidelines in the eight journals under consideration found that not one currently requires clinical trial registration as a condition of publishing the trial's conclusions. And while all but one required authors to privately disclose potential conflicts of interest, three left it up to the editors' discretion whether those disclosures would be published.

An e-mail survey sent to editors of the eight journals on Nov. 2 asked if they would amend their guidelines to meet both criteria. It generated just one response. "We do not currently require registration of clinical trials prior to publication," said David Gershenson of the University of Texas M.D. Anderson Cancer Center and editor of Gynecologic Oncology. "However, we have no objection to requiring this in the future."

Many of the original 15 journals on the CMS list already adhere to the International Committee of Medical Journal Editors' "Uniform Requirements," which require conflict-of-interest disclosure and clinical trial registration. There were several notable exceptions, however.

"At this time, CANCER does not require the authors to register their clinical trials," responded Angela Cochran, managing editor of the American Cancer Society's journal. "However, the editorial board will be discussing this topic in the near future."

When queried about their failure to require clinical trial registration, the editors of the Journal of Clinical Oncology, which is published by ASCO, immediately updated its author guidelines to include the requirement. However, it will only apply to trials that began enrolling patients after Nov. 1, 2006, according to a spokeswoman.

Posted by gooznews at November 14, 2006 08:19 AM