Despite a trend towards increased transparency in clinical-trial data, the US Food and Drug Administration (FDA) is asking whether there are times when participants and researchers should be kept in the dark. As pharmaceutical companies push for studies that first justify a drug's approval, then monitor safety once it reaches the market, the agency fears that publicizing the early data could bias the final results. In raising the matter, the FDA could energize the debate about a long-standing clinical conundrum, says Iain Chalmers, coordinator of the James Lind Initiative, a group based in Oxford, UK, that aims to improve clinical trials. "There hasn't been much discussion about this," he says. "There needs to be much more."
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