AMWA‒EMWA‒ISMPP Joint Position Statementon the Role of Professional Medical Writers
Released January 2017

Introduction
This joint position statement of the American Medical Writers Association (AMWA), the European MedicalWriters Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP)
describes the appropriate role of professional medical writers in the development of medical and scientificpublications, including: articles and supplementary content (eg, video abstracts) for publication in peer-reviewed journals
 abstracts, posters, and oral presentations for dissemination at scientific congresses.
This joint position statement is in line with up-to-date guidelines from several other internationalorganizations.1–13

Responsibilities of professional medical writers
Professional medical writing support helps authors and sponsors to disclose their research in peer-reviewed
journals and at scientific congresses in an ethical,14 accurate,15,16 and timely17 manner, with the ultimate aim ofadvancing patient care. Professional medical writers have extensive knowledge of ethical publication
guidelines.18,19 When assisting authors with communication of the results of company-sponsored research,
they must: follow Good Publication Practice (GPP3) guidelines and International Committee of Medical Journal
Editors (ICMJE) recommendations1,2
 consult appropriate reporting guidelines (eg, CONSORT20 and others collated by the EQUATOR network21)
 ensure that the authors and sponsors are aware of their obligations under these guidelines1,2,20,21
 keep up to date with advances in medical communications ethics and best practices.

Responsibilities of authors who collaborate with professional medical writers
Authors who choose to collaborate with a professional medical writer on manuscripts or congresspresentations must: ensure that they, as authors, have access to all relevant information (eg, protocols, statistical analysis
plans, statistical analyses, and clinical study reports)
 provide intellectual input before writing commences and throughout content development
 ensure that the final text fully reflects the views of, and is approved by, all authors affirm the appropriateness of the final choice of journal or congress acknowledge the provision of medical writing support, including the nature of the support, and thename, highest relevant qualifications (eg, degree or professional credential), and affiliation of theprofessional medical writer accountable for the support provided, and acknowledge the funding sources
for the provision of medical writing support (see Box)
 recognize as a co-author all contributors (including a professional medical writer) who meet the ICMJE
authorship criteria.1
Box. Example of template disclosure statement for professional medical writing support.
“The authors thank [name and qualifications] of [company, city, country] for providing medical writing support/
editorial support [specify and/or expand as appropriate], which was funded by [sponsor, city, country] inaccordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).”

References
1.

International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, andpublication of scholarly work in medical journals. http://www.icmje.org/icmje-recommendations.pdf. Published
December 2016. Accessed December 28, 2016.

2.

Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical
research: GPP3. Ann Intern Med. 2015;163:461–464.

3.

Clark J, Gonzalez J, Mansi B, et al. Enhancing transparency and efficiency in reporting industry-sponsored clinicalresearch: report from the Medical Publishing Insights and Practices initiative. Int J Clin Pract. 2010;64:1028–1033.

4.

World Medical Association. Declaration of Helsinki: ethical principles for medical research involving humansubjects. http://www.wma.net/en/30publications/10policies/b3/. Updated October 2013. Accessed December 20,
2016.

5.

World Health Organization. Statement on public disclosure of clinical trial results.
http://www.who.int/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf?ua=1. Published 2015.
Accessed November 26, 2016.

6.

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), European Federation ofPharmaceutical Industries and Associations (EFPIA), Japanese Pharmaceutical Manufacturers Association (JPMA),
Pharmaceutical Research and Manufacturers of America (PhRMA). Joint position on the publication of clinical trial
results in the scientific literature.
http://www.efpia.eu/uploads/Modules/Documents/20100610_joint_position_publication_10jun2010.pdf.
Published 2010. Accessed November 25, 2016.

7.

Pharmaceutical Research and Manufacturers of America. Principles on conduct of clinical trials: communication ofclinical trial results. http://www.phrma.org/sites/default/files/pdf/042009_clinical_trial_principles_final_0.pdf.
Updated December 2014. Accessed December 20, 2016.

8.

Hamilton CW, Royer MG. AMWA position statement on the contributions of medical writers to scientificpublications. AMWA J. 2003;18:13–16.

9.

American Medical Writers Association. Code of ethics. http://www.amwa.org/amwa_ethics. Updated June 2008.
Accessed September 30, 2016.

10. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers indeveloping peer-reviewed publications. Curr Med Res Opin. 2005;21:317–322.
11. Norris R, Bowman A, Fagan JM, et al. International Society for Medical Publication Professionals (ISMPP) position
statement: the role of the professional medical writer. Curr Med Res Opin. 2007;23:1837–1840.
12. International Society for Medical Publication Professionals. Position statement: the role of the professional
medical writer.
http://www.ismpp.org/assets/docs/Inititives/advocacy/ismpp_ghost_writing_vs_professional_medical_writing_oc
t_2011.pdf. Published 2011. Accessed September 30, 2016.
13. International Society for Medical Publication Professionals. Code of ethics. http://www.ismpp.org/ethics. Updated
November 1, 2016. Accessed November 25, 2016.
14. Woolley K, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry inpublications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin.
2011;27:1175–1182.
15. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Write Stuff.
2010;19:196–199.
16. Gattrell WT, Hopewell S, Young K, et al. Professional medical writing support and the quality of randomised
controlled trial reporting: a cross-sectional study. BMJ Open. 2016;6:e010329.
17. Shah S, Nair S, Patil A, et al. Role of medical publication professional in timely dissemination and transparent
reporting of clinical data. Curr Med Res Opin. 2016;32(Suppl 1):S12.
18. Wager E, Woolley K, Adshead V, et al. Awareness and enforcement of guidelines for publishing industry-sponsored
medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4:e004780.
19. Marusic A, Hren D, Mansi B, et al. Five-step authorship framework to improve transparency in disclosing
contributors to industry-sponsored clinical trial publications. BMC Med. 2014;12:197.
20. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel grouprandomised trials. BMJ. 2010;340:c332.
21. Reporting guidelines for main study types. EQUATOR Network Web site. http://www.equator-network.org/.
Accessed December 20, 2016.