The Good Publication Practice (GPP) Guidelines provide recommendations for individuals and organizations that participate in research publications in peer-reviewed journals and presentations at scientific conferences. The current version is GPP3
Medical writer:
A medical writer (MW) plays an integral role in the drug development process, providing support activities and coordinating with stakeholders, especially in the development of publication plans.
There are now two main guidelines MWs, reviewers, and editors should be proficient in and be aware of GPP3 guidelines and ICMJE guidelines.
Good Publication Practice guidelines (GPP3)
The GPP3 is the recent version, published in 2015, and plays an important role in preventing inaccurate, incomplete, delayed, or misleading research reporting.
● The guidelines emphasize, that the MW as an author is solely responsible for ensuring publication quality and reducing retractions due to misconduct.
● MWs may also be assigned administrative tasks related to submitting presentations to congresses or writing articles for journals if needed.
● The MW should avoid plagiarism and ensure that the findings are presented correctly, clearly, and without any confusion to the readers.
ICMJE Guidelines:
The International Committee of Medical Journal Editors(ICMJE) developed guidelines for conducting and reporting research and other material in medical journals that promote best practices and ethical standards.
● According to the ICMJE, MW/authors are responsible for their publications' content.
● However, authors who are often key opinion leaders (KOLs) in a specific therapeutic area may have limited time in which to learn about publication ethics and reporting guidelines. If that is the case, the MW can assist research sponsors in publishing their data by facilitating communication between cross-functional teams
The American Medical Writers Association, the European Medical Writers Association, and the International Society for Medical Publication Professionals (ISMPP) issued a joint statement on the role of medical writers, which emphasizes the need to follow GPP3, ICMJE, CONSORT, and other guidelines when assisting with company-sponsored research, in conjunction with external authors. Table 1 provides a list of some of the other existing guidelines in the publication and related domains.
Standards for the accurate publication and research presentation
Type of Guidelines | Source |
REPORTING GUIDELINES: Randomised trial/ observational studies ● CONSORT (Consolidated Standards of Reporting Trials) ● STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) Systematic review/Meta-analysis ● PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Case reports ● CARE (Case reports) Studies of diagnostic accuracy ● STARD (Standards for Reporting of Diagnostic Accuracy Studies) Economic evaluations of health interventions ● CHEERS (Consolidated health economic evaluation reporting standards) Qualitative research studies ● SRQR (Standards for reporting qualitative research) | EQUATOR (Enhancing the Quality and Transparency of Health Research) Network (www.equator‑network.org) |
Guidelines on the role of medical writers in developing peer‑reviewed Publications, Code of ethics and position statement ● AMWA ● EMWA | www.amwa.org/ www.emwa.org |
Elsevier ● PERK (Publishing Ethics Resource Kit) Wiley publisher ● Best practice guidelines on publication ethics | www.elsevier.com/editors/publishing‑ethics/perk http://exchanges.wiley.com/ethicsguidelines |
ICMJE (International Committee of Medical Journal Editors) | www.icmje.org/ |
A number of advancements in medical, regulatory, and journal requirements have led to a greater understanding of the publication environment. MWs need to keep abreast of changes and the need to take on more responsibility in the process of medical writing. Furthermore, to stay up-to-date with the current trends, MW must undergo specific training from recognized organizations for enhanced knowledge and for developing the right approach. It enables the production of high-quality research reports and the closure of the research reporting gap.
References
1. Anand G, Joshi M. Good publication practice guideline 3: Evolving standards for medical writers. Perspectives in Clinical Research. 2019 Jan;10(1):4.
2. Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, Citrome L, Gurr JA, Mooney LA, Moore BJ, Peña T. Good publication practice for communicating company-sponsored medical research: GPP3. Annals of Internal Medicine. 2015 Sep 15;163(6):461-4.
MS-MC-BL-22-6