Good Publication Practice
The cycle of articles devoted to the medical writing continues with a text dedicated to the key theme of the Good Publication Practice. The application of this practice is the guarantee of the correctness and the ethics of biomedical texts.
Medical research communication results from the work of numerous professionals around the world and from different scientific background. Authors, collaborators (biostatisticians, professional medical writers), and organizations, including CROs and medical communication agencies share the responsibility for writing articles in a scientifically correct and ethical manner.
To this purpose, in 2003 the International Society for Medical Publication Professionals developed the Good Publication Practice (GPP1) guidelines for communicating company sponsored medical research and in 2009 updated them (GPP2) to comply with the medical research environment in constant evolution. The GPP1 are a list of recommendations that applies to both peer reviewed journal articles and presentations at scientific congresses and helps authors to ensure integrity, completeness, transparency, accountability, and responsibility of their manuscript. The GPP2s further explore the roles of authors, sponsors and other contributors, particularly highlighting the role of professional medical writers in this process, explain how to declare reimbursement and honoraria and to establish a publication steering committee, and recommend the use of a publication plan and the documentation that tracks all the publication process. Following the GPPs ensures to comply the ethical requirements of the Declaration of Helsinki (updated in 2008) that states that accuracy and completeness are primary ethical obligations of individuals communicating medical research. A checklist is available to be aware of what is needed for articles and presentations.
Before starting it is important to write a publication agreement between authors, publication steering committees and sponsor. Authors are individuals who have contributed to the analysis and interpretation of the study and fulfill the authorship criteria of the International Committee of Medical Journal Editors (ICMJE). Their contribution should be clearly described in the Acknowledgments section or in the cover letter, when the journal requirements do not allow inclusion of this information within the article. Professional consultancy of medical writers to prepare their manuscripts is widely accepted. This collaboration should be stated in the Acknowledgements section because professional medical writer should not be ghostwriters. Medical writers may be qualified as authors when they contribute to literature search and relevant contents in the review articles. The lead author should direct the work of medical writer and review outlines and drafts, and before submission all authors should approve the final version of the manuscript. A medical writer should ensure that authors disclose any financial and non-financial conflict of interest.
As soon as possible it is recommended to decide a publication plan that can help the study sponsors to communicate the clinical trial results to medical community in timely manner. The publication plan should identify the submission deadlines to congresses and new areas for publication (secondary studies). All the publication process should be recorded in a specific documentation, including publication agreement, draft and its revisions, timelines, approval from authors of the final version, list of participants other than authors.
The Good Publication Practice should be implemented by all medical research players to achieve an excellent and ethical scientific communication.
Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003;19:149-154.
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.