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