Only full access to trial data will show signs of ghostwriting, meeting hears

Submitted on behalf of the ISMPP Board of Trustees:

This article raises two distinct issues - selective reporting of
trial data and ghostwriting, both of which are of concern to the
International Society for Medical Publication Professionals (ISMPP), a non
-profit organization that advocates for and educates on best practices,
professional ethics, and transparency in medical publishing.

The ISMPP Board of Trustees is pleased to see these challenges
brought forward, shares in the concerns raised, and welcomes opportunities
to collaborate on best practices that result in full disclosure of study
results and transparency in the publication of trial data. While
fundamentally separate issues, trial reporting and full disclosure of
authorship clearly share the common ground of good professional ethics in
medical publishing.

Transparency in Trial Reporting. As with all clinical trials, those
that are sponsored by pharmaceutical companies must fulfil the
requirements of government-appointed regulatory bodies in publicly posting
key details on www.clinicaltrials.gov, EudraCT or other national clinical
trial registries. The US government and European Union have passed
legislation to ensure that all clinical study results are made publicly
available, regardless of the results of the study. Clearly, there have
been past instances of inadequate transparency, which have prompted ISMPP
and other professional organizations such as the American and European
Medical Writers Associations (AMWA and EMWA) to develop additional
guidance aimed to improve the standard of research reporting (e.g.,
GPP2[1] ). Indeed, ISMPP's Code of Ethics [2] requires accuracy,
completeness, fair balance in medical publishing and considers commercial
product promotion inappropriate.

ISMPP continues to support appropriate access to trial protocols and
data in order to ensure scientific integrity. We believe strongly that in
addition to trial reporting, translation and context via peer-reviewed
scientific publications are critical for truly providing meaningful
education that allows for optimum patient care.

Transparency in Authorship. Professional medical writers have a
valuable role in supporting the publication of scientific publications.
By definition, they facilitate the development of a manuscript by
eliciting the direction of byline authors and developing publication
components (e.g., text, figures, tables, etc.) on the basis of author
direction. Professional medical writers are then appropriately
acknowledged for their role in the development of the publication or
recognized as byline authors if they fulfil the authorship criteria of the
publishing journal. ISMPP supports the position of the Workshop attendees
that when byline authors have not directed publication development or when
contributors have not been properly acknowledged or appropriately listed
as authors, this is ghostwriting. ISMPP does not support ghostwriting. We
do, however, advocate for clarity and consensus on the definition of
authorship and the responsibilities thereof.

ISMPP applauds the efforts of the various organizations and
regulators who share the common vision of ensuring integrity in scientific
exchange. We are eager to partner with other societies and organizations
that seek best information for physicians through fulfilling the parallel
goals of transparency and good professional ethics in medical publishing.

References:

1. Graf C, Battisti WP, Bridges D, et al. for the International
Society of Medical Publication Professionals. Good publication practice
for communicating company sponsored medical research: the GPP2 guidelines.
BMJ 2009;339:b4330.

2. ISMPP Code of Ethics. 2010.
http://www.ismpp.org/ISMPP%20CODE%20OF%20ETHICS%2011_10.PDF last accessed
20 May 2011