Obviously, an unblinded trial design (also known as an open-label trial) represents a particularly high-risk approach when the outcome involves a subjective assessment by either the patient or the physician.

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The study was a multinational, single-arm, open-label, 78 week trial that was recently published in the November 2, 2012 online version of the Lancet.

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Despite some limitations of trial design, including the open label nature of the study, RECORD remains the only randomized trial of cardiovascular outcomes for Avandia at this time.

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Dr. Wolf, of Northwestern University, and other researchers, in partnership with the National Institutes of Health and the Agency for Healthcare Research and Quality, recently completed a trial testing a pill-bottle label that provides more explicit instructions and larger font size.

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It will be interesting to see if online clinical-trial registries provide another way of getting data about off-label uses to doctors.

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One bit of upside to the release of the CMS documents was the way Medicare officials treated use of Provenge that goes beyond the current clinical trial data and the Food-and-Drug-Administration-approved label.

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The FDA has strengthened label warnings for Serevent and Advair three times amid wrangling with the company over how to interpret trial data.

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