All medical communicators need to adhere to a strong set of ethics and standards. In particular, regulatory medical writers who collaborate on company‑sponsored biomedical research projects are part of a chain of responsibility for accurately reporting the results of clinical trials.
Since 2003, peer-reviewed publications that report the findings of industry‑funded research have looked to the Good Publication Practice (GPP) guidelines for ethical conduct and transparency when research is sponsored by pharmaceutical companies or other commercial entities. The GPP guidelines have been updated several times, most recently in 2022.
What are the GPP guidelines, and how do they affect the work of professional medical writers and editors?
Good Publication Practice (GPP) Guidelines
The initial publication of Good Publication Practice for Pharmaceutical Companies by Elizabeth Wager, Elizabeth A. Field, and Leni Grossman was intended to establish a set of standards to address the relationships between pharmaceutical companies, clinicians, publishers, and the public.
“These different constituencies often work closely together, especially during clinical trials, and successful collaboration is critical to the development of new medicines,” the authors write. “While the conduct of the clinical trials themselves is heavily regulated, until recently much less attention has been paid to the process of publishing their findings.”
The guidelines, listed in the article’s appendix, discuss the aim, scope, and publication standards. Additional guidelines cover the relationship between external investigators and pharmaceutical companies, premature publication, and duplicate/redundant publication.
There is also a section that covers the role of professional medical writers in creating and preparing manuscripts.
The most recent version of the GPP guidelines, GPP 2022, can also be accessed from the website of the International Society for Medical Publication Professionals (ISMPP), which has facilitated the updating process since its founding in 2005.
The Aim and Scope of GPP Guidelines
The GPP guidelines are meant to supplement existing guidelines already published by individual journals, the International Committee of Medical Journal Editors (ICMJE) and the Consolidated Standards of Reporting Trials (CONSORT) Statement. The ICMJE and CONSORT group’s guidelines were created to establish a standard for publishing the results of clinical trials. The GPP guidelines more specifically address the role of pharmaceutical or other commercial sponsors in publishing trial results.
The GPP guidelines cover publication in print and electronic journals, presentations at scientific meetings and conferences, and both peer-reviewed publications and non‑peer‑reviewed communications such as posters, lectures, and book chapters. The GPP guidelines are not meant to cover promotional materials, which have a different set of regulatory requirements.
They are meant to be used by pharmaceutical companies, other commercial sponsors of clinical trials, and companies and professionals who contribute to industry-sponsored publications such as freelance medical writers, contract research organizations, and communications firms.
Publication Standards
The general standards for publishing are well defined in the ICMJE guidelines and the CONSORT statement. The AMWA Code of Ethics also spells out the general ethical practices that lead to the publishing of accurate, unbiased, objective research. The European Medical Writers Association (EMWA) also has a Code of Behavior.
The GPP guidelines further delineate the relationships between sponsors and investigators.
Defining Relationships
The GPP guidelines recommend a written contract that spells out the relationship between the external investigators and the sponsors; the agreement should address who owns the published data.
The guidelines state that “results from data subsets should not be published in advance of or without clear reference to the primary paper and should not constitute redundant or prior publication.” The companies sponsoring the research should be informed of any plans to publish or review the manuscripts. Sponsors don’t have the right to stop publication, but they may delay publication if it is to “protect intellectual property.”
The statistical reports and data tables in each publication need to be accessible to all authors, and if there are differences in interpreting the findings, the parties should “find a mutually acceptable solution through honest scientific debate.”
Safeguards Against Premature or Duplicate Submissions
With the exception of presenting abstracts, posters, or lectures at conferences, the GPP guidelines recommend adhering to ICMJE guidelines on releasing results to the public. “In the case of findings with major implications for public health or of great commercial sensitivity, it may be helpful to discuss with the journal editor the timing of publication and proposed approaches to the media,” the guidelines state.
Peer-reviewed journals do not accept papers that have been published elsewhere, and the GPP guidelines reinforce prior guidance on that point. When it comes to secondary publications such as symposiums or use of the data in other analyses, these uses of the data need to occur after the initial publication and should reference the original publication.
Studies should be identified with a unique study identifier that is included in all publications.
Authorship and Acknowledgements
When it comes to identifying who is an author versus who is a contributor to a manuscript, the ICMJE’s criteria for authorship remain the gold standard. The GPP guidelines suggest that authorship policies be spelled out in the agreement between investigators and sponsors.
Non-authors who contributed to the manuscript should be listed in the Acknowledgements section of the paper, along with the study’s funding source and any involvement the sponsor or company had in analyzing the data or preparing the manuscript.
The ISMPP’s FAQs on GPP guidelines also address the use of artificial intelligence (AI) in preparing manuscripts. “The use of AI does not alter policies regarding authorship, data integrity, or research ethics,” the organization states.
Professional Medical Writers
When companies employ medical writers to help prepare manuscripts for publication, these professionals are involved in writing, editing, or addressing feedback from contributors. The GPP provides the following guidelines (reproduced verbatim).
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“The named author(s)/contributors must determine the content of the publication and retain responsibility for it.
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The medical writer should begin drafting the manuscript after consultation and discussion with the named author(s)/contributors. It is often helpful if the author(s)/contributors and the medical writer agree on an outline of the paper before detailed writing begins.
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The named author(s)/contributors should be given adequate time to comment on an early draft of the manuscript.
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The medical writer should remain in close and frequent contact with the author(s)/contributors throughout the development of the manuscript.
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The named author(s)/contributors should approve the final version of the manuscript before it is submitted.
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The lead author should be responsible for submitting the manuscript to the journal and acting as the primary contact for interactions with the journal editor.
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The contribution of the medical writer should be acknowledged.”
The guidelines also caution against professional medical writers preparing first drafts of editorial or opinion pieces; assisting authors is, however, acceptable.
The Evolution of the GPP Guidelines
“An Overview of the 2022 Update of Good Publication Practice (GPP) Guidelines: A Medical Writer’s Perspective,” published in the AMWA Journal by Qing Zhou, PhD, ELS, provides a review of the last 20 years of the GPP guidelines and explores the most recent update, GPP 2022.
The update of the GPP guidelines includes
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References to key ethical documents mentioned above, and additional citations of related resources such as AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers.
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Additional “Ethical Principles” for promoting inclusivity, transparency, and scientific integrity.
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“Practical Planning Principles” to guide the day-to-day actions of professional medical communicators.
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Updates to the guidelines to reflect a changing industry, for example
a. “Translational and biomarker studies, nonclinical research, health economics, real-world evidence, and outcomes research.”
b. Plain language summaries and social media postings.
c. Inclusivity in publication teams, including patient involvement.
Increased Role of Medical Writers
The GPP 2022 update includes additional guidance for professional medical writers, emphasizing the importance of treating them ethically and acknowledging their contributions. For example, the GPP 2022
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states that the support of medical writers needs to be disclosed,
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advises that medical writers work under the direction of authors and should be included in meetings that shape documents, and
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notes that medical writers can meet the criteria for authorship.
Resources for Professional Medical Writers
AMWA has many resources for medical communicators navigating the landscape of a rapidly changing industry. Some helpful resources include
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AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers addresses the role and responsibilities of medical writers in creating articles, abstracts, posters, and oral presentations.
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Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 includes the most recent principles and guidance for professional medical writers and others working on critical research content.
A Matter of Ethics
Ethics and transparency are central concerns when it comes to the release of scientific findings to the public. The AMWA Code of Ethics spells out a set of principles that will help professional medical writers navigate the shifting landscape of biomedical research.
AMWA acknowledges the contributions of Nadine Odo, MPH, CCRC, ELS, FACRP, for peer review in the development of this AMWA resource.
