Medical Writing Obesity and Type 2 Diabetes Journal Watch

Volume 21, Issue 4 - Obesity and Type 2 Diabetes

Journal Watch

Abstract

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

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References

  1. Terranova G, Ferro M, Carpeggiani C, Recchia V, Braga L, Semelka RC, et al. Low quality and lack of clarity of current informed consent forms in cardiology: how to improve them. JACC Cardiovasc Imaging 2012;5(6):649–55.
  2. Lundh A, Krogsbøll LT, Gøtzsche PC. Sponsors' participation in conduct and reporting of industry trials: a descriptive study. Trials 2012;13:146.
  3. Kesselheim AS, Wang B, Studdert DM, Avorn J. Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures. PLoS Med 2012;9(8):e1001280doi:10.1371/journal.pmed.1001280.

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In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
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Out On Our Own

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