Pharma Blog Watch

Publishing Unregistered Trials (GoozNews)
In his blog, Merrill Goozner writes that the Centers for Medicare & Medicaid Services (CMS) "may add over a half dozen medical journals to the list of publications that determine reimbursement for the off-label use of anticancer 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."

Medicare has long paid for off-label uses of 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," he writes. The CMS is looking to expand the list of journals, but without a commitment by the publications to insist on trial registration, or federal legislation "requiring universal, mandatory registration of clinical trials," Goozner fears that sponsors who "skip" registration will be rewarded.