GPP3: New guidelines for publishing company-sponsored medical research

Pellet of Lymphocyte Cells Created in the Centrifuge

Companies that sponsor medical research should pay attention to an updated guideline that was recently released. The document, Good Publication Practice for Communicating Company-Sponsored Medical Research“, more commonly known as GPP3, is the third iteration of the guideline, which goes back to 2003.

The guideline covers all types of documents published in peer-reviewed journals (original research articles, short reports, reviews, letters to the editor) and presentations at scientific congresses and meetings (oral presentations, posters, abstracts).
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Are ICMJE authorship guidelines leaving people out?

The most widely referenced and followed guideline for authorship of scientific publications is that issued by the International Committee of Medical Journal Editors (ICMJE). In it, the ICMJE recommends that authorship be determined by:

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

The ICMJE states that

All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors. Those who do not meet all four criteria should be acknowledged.

A recent study looked at challenging authorship scenarios and asked clinical investigators, medical journal editors, publication professionals, and medical writers to decide who should be granted authorship status in these situations and how confident they were in their decision.

Results of the survey study showed several cases where there were higher levels of disagreement between the groups surveyed than other cases. Continue reading Are ICMJE authorship guidelines leaving people out?

Tips to prepare a scientific manuscript that gets published

Recently, I gave a webinar on publishing a scientific manuscript for the American Medical Writers Association (AMWA). [An archived version of the webinar is located AMWA On Demand Webinars.] In the webinar, I reviewed topics including selecting a compatible journal, online resources for literature searches, and writing strategy.

Following the webinar, there was a Q&A session in which I was asked some great questions by the audience. Here is a condensed version of the questions and my answers from the webinar on publishing a scientific manuscript:
 
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The CMPP credential

You may be wondering what the CMPP designation means in my professional title. It stands for “Certified Medical Publication Professional” and is implemented by the International Society for Medical Publication Professionals (ISMPP).

After hours of studying and a lengthy test covering topics such as gap analysis, authorship, publication misconduct, journal selection, and reporting guidelines, I was pleased to learn that I passed the exam. From ISMPP:

The CMPP credential certifies the following:
  • Expertise as a medical publication professional
  • Commitment to ethical and transparent data dissemination standards
  • Leadership in upholding and fostering integrity and excellence in medical publication
  • Proficiency in good publication practices

What does that mean for me and my clients? Well, I am regularly looking for ways to continue and expand my education and the CMPP certification helped push me toward that goal. My clients have another concrete measure by which they can evaluate my experience and an assurance that my work meets best-practice standards.