PharmExec Blog

Heat From FDAAA: Time For New GPP

Good Publication Practice, or GPP, is often the first port-of-call for companies publishing in the biomedical sector.

But consider this. The first ideas for GPP were formed a decade ago, and now the time is right for GPP2: the new, revised Good Publication Practice.

Why now? Pharma publication practice is a hot potato. Purported cases of publication-related ‘misconduct’ or alleged misdemeanors reflected in high profile clinical publications come to light, it seems, every month. More often than not big pharma is the target, like this in the Wall Street Journal, like this in Annals of Internal Medicine.

And then FDAAA turned up the heat. Results posting in 12 months means pharma supported clinical trials will be out there in the public domain quick, and posted in some detail on clinicaltrials.gov.

Clinical publications had better keep up. A peer reviewed analysis of clinical trial data published in a journal and out there when the same data is posted on clinicaltrials.gov means that interpretation is no longer just anyone’s (or everyone’s?) business. And, yes, clinical publications had better shape up too: it’s not good news when stories hit the press about undisclosed conflicts of interest in clinical papers, or suppression of less than favorable data.

GPP2 will deliver best practice guidance for the post-FDAAA era (the ‘post-posting’ era?). It will capture the evolution in best publication practice seen over the last decade, drawing on newest guidance (new Declaration of Helsinki, new ICMJE, and more). As always, GPP will encourage responsible and ethical publication practice. It will help those involved in the publication and communication of clinical information funded by companies to keep up with the rapidly changing environment.

Working with support from the International Society for Medical Publication Professionals, the GPP2 Steering Committee will open its Global Consultation on the first draft of the new guidelines late in 2008. You can expect GPP2 to offer advice about preparing for and executing GPP for clinical trial papers as well as, for example, for special cases like abstracts and presentations, post hoc analysis, meta-analysis, and reviews. Get in touch with Chris Graf to get involved.

Disclosures: Chris Graf is co-chair, ISMPP Standards & Best Practices Committee. He is Associate Editorial Director at Wiley-Blackwell. He is Publisher of International Journal of Clinical Practice. He owns no stocks or shares.

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