Good publication practice for communicating company sponsored medical research: the GPP2 guidelines

Guidelines Do Not Increase Confidence in Integrity of Commercially Sponsored Clinical Research

8 December 2009

These guidelines seem to obfuscate who is responsible and accountable for a particular clinical trial, and for articles written reporting on such a trial.

The guidelines ignore the time-honored concept of a "principal investigator" who is responsible for the entirety of a research project. Instead they allow for each manuscript arising from a clinical trial to have both a lead author and a "guarantor." The latter is envisioned as having "overall responsibility for the integrity of a study and its report." Then who appoints the guarantor? Who is responsible for the integrity prior to his or her appointment? When a trial generates more than one manuscript, would they necessarily have the same guarantor? If not, who would ultimately be responsible, and how would disagreements be resolved?

The guidelines prevent understanding of who ought to be the authors of a manuscript, what their responsibilities should be, and how accountable they are for the manuscript. The distinctions among "contributors," "authors," "investigators," "sponsor employees," and "individuals contracted by the sponsor" are unclear.

In particular, the guidelines seem to condone ghost authorship. They would not prevent a professional medical writer from writing an initial outline, the first draft, and all subsequent drafts. including the final draft of a paper. Yet that writer would not necessarily be an author, since only if if he or she is willing to "take public responsibility for relevant portions of the content" then he or she may be in a position to meet the remaining ICMJE criteria for authorship. Of course, this would allow a professional writer to simply be unwilling to take such responsibility in order to avoid being listed as an author.

In my opinion, these guidelines do little to increase confidence in the integrity of commercially sponsored clinical research.

Note: the above was derived from a longer commentary on the blog Health Care Renewal (http://hcrenewal.blogspot.com) which is available here:

http://hcrenewal.blogspot.com/2009/11/how-industry- views-research-it -sponsors.html

Competing interests: None declared

Competing interests: None declared

Roy M Poses, President, Foundation for Integrity and Responsibility in Medicine

16 Cutler St, Suite 104, Warren, RI, 02885, USA

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