As a publications manager with JB Ashtin’s Client Services team, I oversee publication projects, manage publication plans, and coordinate all medical writing activities as they relate to approval and release of abstracts, posters, manuscripts, white papers, slide decks (and a myriad other projects), all in an effort to meet our clients’ objectives. To help our clients report their findings effectively, I need to know my stuff when it comes to working with pharma and medical device companies engaged in sponsored medical research.
JB Ashtin has been a player in the scientific communications industry for more than 16 years, and during this time, we’ve noted that our clients usually struggle with common publication challenges that include authorship issues, speed to press, data sharing challenges, transparency and disclosure responsibilities, and their overall role as clinical study sponsor, to name a few. In this blog, I briefly review what’s new in the third edition of the Good Publication Practice (GPP3) guidelines, which was recently released in the August issue of the Annals of Internal Medicine1 (and also found here: http://goo.gl/EWhSye).
As originally outlined in GPP2,2 the GPP3 guidelines continue to champion decision-making to maintain ethical practices for those who write or contribute to research publications sponsored by pharmaceutical/medical device companies and to ensure compliance with legal and regulatory requirements. However, GPP3 goes further by providing more decisive guidance, relating specifically to medical publication. GPP3 provides 10 guiding principles that cover reporting results, defining roles and responsibilities of authors and sponsors, and emphasizing the importance of publication planning:
The design and results of all clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner
Reporting and publication processes should follow applicable laws (for example, Food and Drug Administration Amendments Act of 2007) and guidelines (for example, ICMJE recommendations and reporting guidelines found on the Enhancing the QUAlity and Transparency Of health Research [EQUATOR] Network)
Journal and congress requirements should be followed, especially ethical guidelines on originality and avoiding redundancy (that is, duplicate publication)
Publication planning and development should be a collaboration among all persons involved (for example, clinicians, statisticians, researchers, and publication professionals, including medical writers) and reflect the collaborative nature of research and the range of skills required to conduct, analyze, interpret, and report research findings
The rights, roles, requirements, and responsibilities of all contributors (that is, authors and any nonauthor contributors) should be confirmed in writing, ideally at the start of the research and, in all cases, before publication preparation begins
All authors should have access to relevant aggregated study data and other information (for example, the study protocol) required to understand and report research findings
The authors should take responsibility for the way in which research findings are presented and published, be fully involved at all stages of publication and presentation development, and be willing to take public responsibility for all aspects of the work
Author lists and contributorship statements should accurately reflect all substantial intellectual contributions to the research, data analyses, and publication or presentation development. Relevant contributions from persons who did not qualify as authors should also be disclosed
The role of the sponsor in the design, execution, analysis, reporting, and funding (if applicable) of the research should be fully disclosed in all publications and presentations of the findings. Any involvement by persons or organizations with an interest (financial or nonfinancial) in the findings should also be disclosed
All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication or presentation
GPP3 also provides decisive clarification on:
International Committee of Medical Journal Editors authorship criteria3 (with a quick reference table)
Common authorship issues (with a quick reference table)
Author payment and reimbursing out-of-pocket expenses
Authorship criteria and eliminating ghost and guest authors
The role of professional medical writers and potential benefits to using their services
Distribution of data
Our clients count on us to stay up to date on all relevant changes to industry guidelines and government regulations. The JB Ashtin team began applying these updated GPP3 guidelines the same day they were published to guarantee high-quality scientific communications and ensure integrity, accountability, and responsibility for accurate, complete, and transparent reporting.
WP Battisti et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015. Epub ahead of print. Online 11 August 2015.
Graf C, Battisti WP, Bridges D, et al. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009;339:b4330.
International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Available at: www.icmje.org/recommendations.