Monday, November 22, 2010

Good Publications Practice 2 and You (Open Session 36)

by Heather Haley

Navigating the current medical publishing environment is challenging, whether it’s figuring out which of the many CONSORT statement extensions applies to your project or collecting all the conflict of interest disclosures from ten authors in four countries. However, success starts with knowing Good Publication Practice 2. Published in October 2009 in the British Medical Journal, Good Publication Practice 2 (GPP2) captures the best current standards for communicating medical research sponsored by companies.  (For a copy of GPP2, visit the Web site, where you can also watch a webcast about it.)

Covered in the AMWA 2010 conference open session, Navigating the Current Medical Publications Environment, key GPP2 recommendations include:
  • Written agreements between the company and academic-physician authors.
    • These author agreements can address a host of issues from access to data, author obligations to disclose conflicts of interest, author responsibilities for timely publications. The GPP2 paper has a great checklist of what to include in an author’s agreement.
  • Contributorship model for the acknowledgements section for people who do not meet the ICJME authorship criteria as well as the role of the sponsoring company in funding and executing of research.
    • Suggested language for contributorship is: “The authors would like to thank D, YZ Pharmaceuticals, for overall management of the trial and E, WX Medical Writing, for drafting the manuscript.”
    • The role of the sponsor in the medical research needs to be detailed. Suggested template language that can be adapted to each situation is: “In collaboration with A and B, YZ Pharmaceuticals, designed the study, analysed, and interpreted the data, and edited the report. Data were recorded at participating clinical centres and maintained by YZ Pharmaceuticals. All authors had full access to the data." If journal submission requirements do not accommodate this information, then put it in the cover letter accompanying the submission.
  • Creating publication steering committees to identify and oversee the communication of research results in presentations and journal publications.
    • Visit the GPP2 website for ideas on who belongs on publication steering committees.
The key theme for GPP2 is transparency. In this current environment of controversy, more disclosure is the rule of thumb when in doubt. The GPP2 authors recommend going above and beyond disclosing conflicts of interest and medical writing support on posters as well as publications. Since no one becomes a Wall Street Journal story for disclosing conflicts of interest.

A highlight for GPP2 is that the update was a more collaborative process seeking input from all the key stakeholders. 116 individuals representing academic centers, journal editors and publishers, medical communication agencies, freelance medical writers, pharmaceutical, medical device, biotechnology, and professional organizations provided comment on the first draft of GPP2.

The Navigating Medical Publications talk was attended by about 30 people, and honestly I was surprised by the number of people who didn’t know the GPP2 update had come out. New publishing or research reporting guidelines can be found at the Equator network. Read Good Publications Practice 2, for yourself. It’s definitely a must if you are taking the Certified Medical Publication Professional exam (CMPP). But also, pass along some of the useful checklists or template language to your colleagues or clients to help make navigating the current medical publishing environment a little easier for everyone.

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