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Journal Watch

Authors: Nancy Milligan

Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers to use standard plain language to provide patients with all of the relevant information they need on risks and benefits in order for them to make well-considered decisions about their treatment. There has been a lot of concern about bias and influence in industry-sponsored studies following a number of articles suggesting that industry-sponsored trials usually favour the company's product. Off-label use is the practice of prescribing a drug for an unapproved indication or age group or using an unapproved dosage or route of administration. It is illegal for pharmaceutical companies to directly promote off-label uses, but many companies have paid physicians and researchers to endorse off-label uses of their products

Medical Writing. 2012;21(4):311–312

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