USE OF GPP3 FOR ETHICAL GUIDANCE

An Academic presentation byDr. Nancy Agnes, Head, Technical Operations, Pubrica Group: www.pubrica.comEmail: sales@pubrica.com

Outline

Today's Discussion

In-BriefIntroduction

GPP Historical Archive What is New in GPP3 Role of ISMPPFuture Scopes Conclusion

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.

In-Brief

IntroductionGPP3 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.

Contd...

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.

GPP Historical Archive 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 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.

Contd...

GPP3 FOR ETHICAL GUIDELINES, 2015

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).

Step 1: ISMPP

Step 2: Publication Steering Committee

Step 3: Reviewer Panel

Step 4: Steering Committee

Contd...

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.

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."

Contd...

What is New in GPP3 Guidance on updated ICMJE 2013 authorship criteria

Advice on everyday issues about authorship

Author payment and compensation guidance and

clarification Further definitions of what creates guest

or ghost invention

Information on the position andbenefits of licenced medical authors has been expanded

Contd...

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.

Contd...

"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.

Contd...

Role of ISMPP

ISMPP was the energetic force behind the adoption of theGPP3 guideline.

By supplying logistical research paper support, giving access to the mailing list of ISMPP participants, sending out e-mails to members 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.

Contd...

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.

Future Scopes We hope

guidelines available

that and

(such

themany

GPP3 will addto recommendations

valuable already Medical Editors,

that are the American of Science

as thosefromWriters Association,

CouncilCommittee on Publication Ethics,European AssociationofScienceAssociation,

Editors, European Medical WritersICMJE, International FederationofPharmaceutical Manufacturers & Associations),

ISMPP, Medical Publishing Insights and Practices, and the World Association of Medical Editors) all promote responsible publishing practices and research.

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.

Contd...

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.

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