Clinical trial  guidelines from PhRMA, the drug industry trade group, go into effect on October 1, 2009. The big news is that there is now a more restrictive definition of who exactly can contribute and be credited in the authoring of scientific papers. From the Wall Street Journal Health Blog: New Pharma Guidelines: No Ghostwriting, More Public Info:

Anyone who makes “substantial contributions” to a study, writes or revises intellectually important parts of a manuscript and has final approval over what is published should be listed as an author, the guidelines say. People who contribute but don’t qualify as authors should be listed in the acknowledgments. If authors get help, they “should disclose the identity of the people that provided the assistance and any entity that supported it.”

Companies should post “summary results” of all clinical trials of drugs that have been approved for sale, and of drugs that have been dropped from the pipeline, the guidelines say. This is relevant because companies have been criticized for publicizing results that reflect well on their drugs, and burying results that make their drugs look bad.

Trials of experimental drugs that are still in development are exempted because posting trial results could “jeopardize important intellectual property,” the guidelines say. Also worth noting: The guidelines aren’t retroactive, so they’ll apply only to new findings.

A doctor who has an ownership stake in a drug can’t be a clinical investigator in a trial of that drug. So if a doc discovers a drug, then licenses it to a pharma company, the doc can’t be one of the researchers who treats patients in a study of the drug. That would “present an inherent conflict of interest,” the guidelines say. Why is this worth flagging? Ask Chuck Grassley.

Read it all.