Good Publications Practice Update: GPP 2022
The new instalment of the Good Publications Practice guidelines (GPP 2022) has recently been published in the Annals of Internal Medicine.1 GPP 2022 is the fourth version of the GPP guidelines, originally published in 2003 and previously updated in 2009 and 2015. The GPP guidelines are the key document guiding the publication of company-sponsored biomedical research, providing recommendations on ethics and transparency, as well as on the publication processes. These guidelines help promote the development of biomedical publications with transparency and integrity.
GPP 2022: What has changed?
Many of the principles in previous GPP iterations have been retained, with the major changes being reorganisation of the guidelines and augmentation of existing guidance. The reorganisation has resulted in the GPP guidelines supplement being structured in ten sections, covering guidance and process steps for the following areas:
GPP 2022 includes extended guidance on publication planning, covering publication steering committees and working groups. There has additionally been expansion to the guidance surrounding the publication process, including more detailed information on publication types, congress presentation, the steps in publication development and authorship.
The GPP steering committee have introduced several new areas into the guidelines. These new areas include alliances between companies, the role of patients in publications, the use of social media, and enhanced content, including plain language summaries. There has certainly been a shift towards inclusivity with the guidelines specifically considering diversity in demographic characteristics, geography, and job roles.
Increasing responsibilities of authors
GPP 2022 includes changes to the publication process and, in particular, there has been clarifications regarding the roles and responsibilities of the authors. Indeed, to qualify as an author it is recommended that the International Committee of Medical Journal Editors (ICMJE) criteria are followed, which ensure authors are making appropriate contributions to the publication. GPP 2022 has now added to this, defining responsibilities that should lie with authors. It is recommended that a subset of authors should compose a publication outline for critical author review, while a professional medical writer may assist from the first full draft. Additionally, it is stated that authors, not medical writers, are responsible for the final quality and data accuracy of the publication. This, however, does not mean that medical writers cannot also perform quality and accuracy checks, but the final responsibility ultimately lies with the authors. For medical communication professionals these changes are particularly significant, and going forward the balance between the responsibilities of authors and medical writer will need to be refined.
Patient inclusion, accessibility, and innovation in publications
At Costello Medical we are always looking to remain at the leading-edge of medical communications, keen to incorporate innovative approaches to publications. Particularly pertinent, therefore, in the 2022 update are the additions of guidance on patient inclusion, the use of enhanced content and social media.
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GPP 2022 notes that patients, caregivers and patient advocates may be included in publication steering committees or working groups, especially for rare or chronic conditions. Patients and patient advocates should be regarded as experts, and can act as consultants or contributors to publications. Patients can also be authors, and should be listed as such if their contributions qualify them.
Additionally, patients and patient advocates can aid the development of enhanced content and plain language summaries, to ensure they are understandable for non-experts. Plain language summaries can take various formats, including text, video, audio, or infographic. The GPP 2022 guidelines recommend that ideally a plain language summary should appear alongside every biomedical publication, and should be peer reviewed, indexed, fully discoverable and available as open access.
The 2022 update also includes guidance on communication with the public. Social media posting related to specific products and company-sponsored research about those products should be limited to company-sponsored accounts, and not personal accounts of individual employees of sponsors or medical communication agencies. With the appropriate permissions, and adhering to local laws (e.g. the ABPI code), company websites can post peer-reviewed publications and published abstracts for the public.
The shift to cover patient inclusion and plain language summaries in the guidelines indicates a clear effort to move towards inclusivity and accessibility. Allowing those outside of the scientific community to engage with biomedical publications is a hot topic.
Future Directions
This is the fourth instalment of the GPP guidelines and, of course, will likely not be the last. The 2022 update represents a continuation of efforts to encourage and establish good publication practice, however the biomedical and publication fields are continuously evolving. The authors note that advances in artificial intelligence, preprint servers, and online media will disrupt the current publication landscape and enhance communication possibilities.
References
1.????????DeTora, LM; Toroser, D; Sykes, A et al. Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update. Annals of Internal Medicine. 2022.
Principal Consultant at First in Human Communications / Managing Director at Kainic Medical Communications
2 年A key change has been missed in this article regarding authorship. "It is stated that authors, not medical writers, are responsible for the final quality and data accuracy of the publication" is simply repeating the ICMJE authorship criteria. That is also what was said in GPP3. What is really important, and not recognized here, is the change of language in GPP 2022 to suggest that authors should be "publicly accountable" for publications. This moves beyond basically promising to look into it if there is an issue, to authors being fully prepared to stand up in front of their peers and say it was their error, not the study sponsor. I think that is very important to pay attention to as a medical writer because authors should be made aware of this.