use of gpp3 for ethical guidance – pubrica

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Use of GPP3 for Ethical Guidance

Dr. Nancy Agnes, Head,

Technical Operations, Pubrica

sales@pubrica.com

In-Brief

GPP3 is a revision of the original Good

Publication Practice (GPP) standards,

which were first published in 2003 and last

revised in 2009. The ISMPP GPP3

Steering Committee has revised the 2009

edition of the Good Publication Practice

Guidelines (GPP2) to emphasise integrity

and transparency in industry-sponsored

publication planning and development in

today's environment.

I. INTRODUCTION

GPP3 is a revised version of the Good

Publishing Practice (GPP) guideline that

offers guidelines for persons and

organisations involved in disseminating

research findings funded or assisted by

pharmaceutical, medical device, diagnostics,

and biotechnology industries. The guidelines

are meant to help individuals and

organisations adhere to legal and regulatory

standards while ensuring fair and open

publishing activities. These guidelines apply

to peer-reviewed journal publications and

oral and poster presentations at science

conferences.

The following are some of the latest subjects

discussed in GPP3:

The most recent ICMJE authorship

conditions are explained (2013)

Authorship problems that are frequently

found

Author payment and repayment are now

more explicitly described.

Clarification of the words "ghost fiction"

and "guest authorship."

Professional medical writers: what they

do and how they help

Advice on how to exchange data

acceptably.

II. GPP HISTORICAL ARCHIVE

GPP2 Guidelines, 2009

International Society for Medical

Publication Professionals (ISMPP)

assembled a Steering Committee to produce

an updated Good Publication Practice guide,

now known as "GPP2," to discuss

regulatory, guidance, and ethical changes

since 2003 and to affirm the goals of the

initial 2003 publication(4)

.

GPP Guidelines, 2003

The critical Good Publication Practice

(GPP) guidelines, released in 2003, aimed to

ensure that "clinical trials funded by

pharmaceutical firms are published

responsibly and ethically."

GPP3 for ethical guidelines, 2015

The resulting guideline adds new parts

(Principles of Good Publication Practice for

Company-Sponsored Medical Research,

Data Sharing, Studies That Should Be

Published, and Plagiarism). It builds on

Copyright © 2021 pubrica. All rights reserved 2

authorship requirements and widespread

authorship concerns established by the

International Committee of Medical Journal

Editors., Expand details on the position of

medical writers and explain appropriate

author payment and reimbursement.

Individuals and organisations can embody

honesty, transparency, and obligation for

reliable, complete, and transparent reporting

in their publications and presentations by

adopting good publishing practices

(including GPP3).

III. WHAT IS NEW IN GPP3

Guidance on updated ICMJE 2013

authorship criteria

Advice on everyday issues about

a uthors hip

Author payment and compensation

guidance and clarification

Further definitions of what creates

guest or ghost invention

Information on the position and

benefits of licenced medical authors

has been expanded

Advice for appropriate data sharing

Overall simplification of language

and format with a new guiding

principles section and quick reference

tables addressing guidance on

authorship criteria and joint authorship

issues

We use the terms "publications" and

"presentations" interchangeably in the

guideline to refer to the wide variety of

formats presented in peer-reviewed journals

(for example, original research papers, brief

reports, analyses, or letters to the editor) and

"abstracts," "posters," and slides for oral

presentations at scientific congresses.

"Sponsors" are organisations that offer

primary resources for a study, such as

funding. Professional medical researchers,

publishing designers, and publication

administrators are known as "publication

practitioners," and they work in or with

businesses. Regulatory documents, medical

education services, and marketing and

promotional materials are governed or

accredited by various national or state

bodies and are not protected by this

guideline.

IV. ROLE OF ISMPP

ISMPP was the energetic force behind the

adoption of the GPP3 guideline. By

supplying logistical research paper support,

giving access to the mailing list of ISMPP

participants, sending out e-mails to members

Copyright © 2021 pubrica. All rights reserved 3

and prospective reviewers, maintaining the

database of respondents, setting up the

reviewer Web site, and reviewing the GPP3

steering committee, the sponsor was able to

assist in the formation of the GPP3 steering

committee. Several members of the steering

committee also sit on the ISMPP Board of

Trustees. They did, however, contribute to

GPP3 as entities, not on behalf of ISMPP.

The quality of this guideline was not guided

or regulated by the ISMPP employees.

V. FUTURE SCOPES

We hope that GPP3 will add to the many

valuable guidelines and recommendations

that are already available (such as those

from the American Medical Writers

Association, Council of Science Editors,

Committee on Publication Ethics, European

Association of Science Editors, European

Medical Writers Association, ICMJE,

International Federation of Pharmaceutical

Manufacturers & Associations), ISMPP,

Medical Publishing Insights and Practices,

and the World Association of Medical

Editors) all promote responsible publishing

practices and research.

VI. CONCLUSION

Because of advancements in regulatory,

medical, and journal standards, our

understanding of the publishing environment

has changed. The GPP3 guideline has been

amended to keep up with the changes. The

role, reimbursements, and increased

responsibility of MWs in the process have

been identified and elaborated to a greater

extent. Necessitates MW staying current

with current trends and undergoing

specialised training from known institutions

to improve understanding and formulate a

proper strategy. It is required to produce

high-quality documentation and the bridging

of the gap between research conduct and

reporting. Avail Publication support services

from Pubrica.

REFERENCES

1. 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;163:461-464;

doi:10.7326/M15-0288

2. Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke

M, Julious S, et al. Reducing waste from incomplete

or unusable reports of biomedical research. Lancet.

2014;383:267-76. [PMID: 24411647] doi:

10.1016/S0140-6736(13)62228-X

3. Wager E, Field EA, Grossman L. Good publication

practice for pharmaceutical companies. Curr Med Res

Opin. 2003;19:149-54. [PMID: 12814125]

4. Graf C, Battisti WP, Bridges D, Bruce-Winkler V,

Conaty JM, Ellison JM, et al; International Society for

Medical Publication Professionals. Research Methods

& Reporting. Good publication practice for

communicating company sponsored medical research:

the GPP2 guidelines. BMJ. 2009;339:b4330. [PMID:

19946142] doi:10.1136 /bmj.b4330

5. Wager E, Woolley K, Adshead V, Cairns A, Fullam J,

Gonzalez J, 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.

[PMID: 24747794] doi:10.1136/bmjopen-2013-

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