Good Publication Practice 2: Drivers Toward GPP3

The Good Publication Practice (GPP) 2 guidelines have become widely recognised as the primary ethical framework governing the communication of industry-sponsored medical research. Published in 2009 [1], GPP2 was developed in response to persistent concerns about ghostwriting, selective publication, and undisclosed sponsor influence, and sought to formalise good practice in a way that aligned industry activity with prevailing editorial and ethical standards [1].

At its core, GPP2 articulated a clear expectation that publication decisions should be driven by scientific merit rather than commercial considerations. It reinforced the principle that study results, positive, negative, or inconclusive, should be disseminated accurately and responsibly, addressing longstanding concerns about publication bias in the biomedical literature [2]. By 2013, this principle was broadly accepted within publication planning functions, even if its consistent implementation remained variable across organisations.

Authorship, Contributorship, and Transparency Under GPP2

One of GPP2’s most significant contributions is its explicit alignment with ICMJE authorship criteria [3]. GPP2 emphasises that named authors must meet established standards for intellectual contribution and accountability, while all other contributors, including statisticians and medical writers, should be appropriately acknowledged. This clarity helped distinguish legitimate professional support from unethical ghostwriting, a distinction that had previously been blurred in public discourse [4].

Transparency and disclosure are similarly central to GPP2. The guideline requires disclosure of funding sources, conflicts of interest, and the role of the Sponsor in study design, analysis, and reporting [1]. Such disclosures have become (more or less) routine expectations of most high-impact journals, reflecting the growing influence of editorial policies and ethics bodies such as the Committee on Publication Ethics (COPE) [5]. GPP2 has played an important role in normalising these practices within industry settings.

Crucially, GPP2 explicitly legitimised the role of professional medical writers, provided their involvement was transparent and authors retained control over content and interpretation [1]. This position supports the professionalisation of medical writing and acknowledges the complexity of modern clinical research communication, while maintaining clear boundaries around authorship responsibility.

Scope and Practical Limitations of GPP2

Despite its strengths, several limitations of GPP2 have become increasingly apparent. Most notably, its scope is largely focused on peer-reviewed journal publications. Although GPP2 acknowledged other forms of communication, it did not fully address the growing importance of congress presentations, trial registry postings, or sponsor-led disclosures as integral components of the scientific record. This limitation became more pronounced as regulatory and societal expectations for transparency intensified. Requirements for prospective trial registration and public posting of results, particularly through ClinicalTrials.gov,  are no longer optional ethical aspirations but regulatory obligations in many jurisdictions [6]. While GPP2 supports transparency in principle, it offers limited operational guidance on managing these expanding disclosure obligations in a coordinated manner.

Drivers for the Initiation of GPP3

By the early 2010s, the landscape of medical communication has evolved significantly. Scientific dissemination increasingly extends beyond journals, encompassing registries, conference materials, and emerging digital platforms. At the same time, calls for greater data sharing and public access, driven by regulators, funders, and patient advocates, are reshaping expectations of evidence ownership and accountability [7].

Industry-sponsored research is also subject to heightened scrutiny, with increased attention to consistency across disclosures, alignment between protocols and publications, and the governance of publication decision-making [8]. These pressures expose gaps in GPP2, particularly its limited guidance on publication planning, documentation, and cross-channel consistency.

The initiation of GPP3 is therefore not a repudiation of GPP2, but a recognition that its principles need to be extended and operationalised for a more complex and transparent environment. GPP3 is being conceived to broaden the definition of “publication,” strengthen expectations around timeliness and completeness of disclosure, and provide more explicit guidance on governance and accountability across the full lifecycle of scientific communication.

Practical Implications for Pre-GPP3 Publication Practice

In practice, many organisations are already stretching beyond the formal boundaries of GPP2, developing internal publication policies and oversight mechanisms to manage growing transparency requirements. The move toward GPP3 reflects a need to codify these evolving practices into a coherent, externally recognised framework. For medical writers and publication planners, this period of development marks a transition from a primarily manuscript-focused role to one increasingly embedded in strategic publication planning and governance. GPP2 provides a solid ethical foundation; the development of GPP3 will be driven by the need to adapt that foundation to a broader, more scrutinised, and more interconnected publication ecosystem.

References

1. Graf C, Battisti WP, Bridges D, et al. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009;339:b4330.
2. Dickersin K, Rennie D. Registering clinical trials. JAMA. 2003;290:516–523.
3. International Committee of Medical Journal Editors. Defining the role of authors and contributors. N Engl J Med. 2001;344:1840–1845.
4. Lotery, A. Authorship and the role of medical writers. Eye 26, 1 (2012).
5. Committee on Publication Ethics (COPE). Code of conduct and best practice guidelines for journal editors. 2011.
6. Zarin DA, Tse T, Williams RJ, et al. The ClinicalTrials.gov results database. N Engl J Med. 2011;364:852–860.
7. Godlee F. Clinical trial data for all drugs in current use. BMJ. 2012;345:e7304.
8. Rennie D, Emanuel L. When authorship fails. JAMA. 1997;278:579–585.