In August, a major milestone in the ethical communication of industry-sponsored biomedical research was reached with the publication of the Good Publication Practice 3 (GPP3) guidelines [1]. These guidelines provided an updated framework for the development, dissemination, and reporting of company-sponsored clinical studies [2], expanding on earlier versions published in 2003 and revised in 2009 as GPP2 [1,3]. The evolution of these guidelines reflected growing concerns regarding transparency, responsible authorship, data sharing, and avoidance of biased dissemination [2], issues that have long challenged the credibility of biomedical literature.
GPP3 was developed under the auspices of the International Society for Medical Publication Professionals(ISMPP) and built upon a steering committee representing multiple publication stakeholders [4]. Its publication was a response to the increasingly complex landscape of biomedical publishing, encompassing not only journal articles but also congress presentations and digital content dissemination. The guideline aimed to instil integrity, accountability, and responsibility in how industry-sponsored research findings are communicated to clinicians, researchers, and the public [1,4]. In its scope, GPP3 addresses several key areas that had been inadequately covered by earlier iterations, including data sharing mandates, fraud and plagiarism avoidance, and detailed descriptions of authorship roles and ethical responsibilities.
A core principle of GPP3 is transparency and integrity in reporting, emphasising the need to disclose both financial and non-financial conflicts of interest and to ensure that company sponsorship is clearly identified in publications. Recognising the influential role of professional medical writers and publication planners, GPP3 also provided explicit guidance on proper acknowledgement of contributors, with the intention of reducing ghostwriting and ensuring that authorship reflects substantial contributions as defined by the International Committee of Medical Journal Editors (ICMJE) criteria [1]. This alignment with ICMJE authorship criteria was critical because prior research had documented inconsistent authorship practices that might obscure accountability and scientific contribution.
Accurate and balanced reporting of clinical findings, including negative results, was another pillar of GPP3. Underreporting of negative or null results is a well-recognised source of publication bias, with implications for systematic reviews, clinical guidelines, and patient care. Although GPP3 itself does not directly mandate publication of all results, it emphasises reporting practices that avoid selective outcome reporting and stress the ethical obligation to disseminate accurate data in a timely fashion [1]. Related efforts such as the EQUATOR Network and CONSORT reporting standards have also sought to address deficiencies in reporting quality, although adherence to these standards remains variable in practice.
The ethical considerations emphasised in GPP3 also includes patient confidentiality, avoidance of plagiarism, and clear definition of the roles played by study Sponsors. Transparency in these areas became increasingly important in light of growing public scrutiny of industry influence on clinical research reporting.
One tangible impact of GPP3 will be increased attention to professional medical writing support and its transparent reporting. Studies indicate that manuscripts developed with acknowledged professional writing assistance like the ones we provide at Niche are associated with higher adherence to key reporting standards, such as specified CONSORT criteria for randomised trials. This suggests that proper implementation of GPP3 recommendations improves the completeness and accuracy of clinical reporting, although it also reveals that real-world practices vary and that further work is needed to ensure uniform adoption.
Despite its influence, GPP3 is not a regulatory mandate but rather a set of consensus-based best practices reflecting contemporary expectations in industry publication planning and medical communications. Critics note that, as a form of self-regulation, GPP3 may not fully eliminate commercial biases or prevent inappropriate marketing via scientific articles, particularly when companies or authors seek competitive advantage. Such critiques reinforce the notion that ethical publication depends not only on guidelines but also on cultural norms, editorial policies, and robust peer review.
The landscape around Good Publication Practice continues to evolve. This latest iteration acknowledges new realities in biomedical publication, such as plain-language summaries and patient involvement, extending and modernising the framework.
In summary, the introduction of GPP3 represents a major step forward in the ethical communication of company-sponsored clinical research, emphasising transparency, authorship integrity, accurate reporting, and ethical conduct. Early indications suggest that these guidelines will contribute to heightened awareness of publication ethics and improved reporting practices, although challenges remain in universal adoption and consistent application across diverse research ecosystems. As publication standards continue to develop, the legacy of GPP3 persists in ongoing efforts to strengthen trust in biomedical literature and ensure that clinical research reports serve the needs of clinicians, patients, and policymakers with clarity and integrity.
References
- Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015;163(6):461–464.
- Hardman TC. Anand G. Good publication practice guideline 3: Evolving standards for medical writers. 2019.
- Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, et al. Good publication practice for communicating company-sponsored medical research: the GPP2 guidelines. BMJ. 2009;339:b4330.
- ISMPP. GPP3 Guidelines, 2015. International Society for Medical Publication Professionals.
