The Committee on Publication Ethics (COPE) was established in 1997 to address research and publishing ethics violations. Its goal was to identify workable solutions to the problems and create best practices. It is a non-profit organization that offers a discussion forum and guidance to scientific editors. The guidelines were developed from a prototype drafted by individual committee members and then circulated for extensive comment. These guidelines are meant to be advisory rather than mandatory and change over time.

The Good Publishing Practice (GPP) guidelines provide recommendations for individuals and organizations involved in distributing research findings supported or facilitated by the biotechnology, pharmaceutical, medical device, or diagnostic sectors. They are designed to make it easier for people and organizations to follow the law and Regulatory requirements while ensuring fair and transparent publication practices. These GPP guidelines were endorsed by medical journals and cited in their author instructions. Peer-reviewed journal articles, as well as oral and poster presentations at science conferences, are covered by these guidelines.

History of GPP Guidelines

There are three (03) versions of the GPP guidelines, which are:

1. GPP Guidelines, 2003

In 2003, the GPP guidelines were created to ensure that "clinical trials supported by pharmaceutical businesses are published responsibly and ethically."

2. GPP2 Guidelines, 2009

To produce an updated GPP guide, now known as "GPP2," the International Society for Medical Publication Professionals (ISMPP) assembled a Steering Committee. It discussed Regulatory, guidance, and ethical changes since 2003 and reaffirmed the objectives of the initial 2003 publication.

3. GPP3 Guidelines, 2015

The most recent modification, the GPP3, was sponsored by the ISMPP and attempted to improve and clarify the principles and practices outlined in the earlier versions while considering changes in the environment for medical publications. The resulting standard includes additional sections such as the ‘Principles of Good Publication Practice for Company-sponsored Medical Research, Data Sharing, Studies that Should Be Published, and Plagiarism.’ It further supports and expands on the authorship standards and general concerns about authorship developed by the International Committee of Medical Journal Editors (ICJME). Additionally, it covers proper author payment and reimbursement. By using excellent publishing practices, individuals and organizations can reflect honesty, transparency, and the responsibility for accurate, comprehensive, and transparent reporting in their publications and presentations.

Importance of GPP3 Guidelines

• Guide how to develop and publish findings from clinical trials sponsored by pharmaceutical companies, responsibly and ethically
• Demonstrate the industry’s commitment to integrity, accountability, and responsibility for accurate, complete, and transparent reporting of company-sponsored publications
• Broadly applicable to non-industry sponsored research such as academic and government-funded work

Methods used to develop GPP3

As mentioned above, Steering Committee was formed while developing the GPP3. The Committee used a repeated survey process to gain agreement on the new version's scope, title, and format. Subcommittees updated or developed certain sections after the outline was agreed upon. The preliminary GPP3 guidelines were distributed to the reviewer panel after the Steering Committee prepared, revised, evaluated, and approved the first draft version. The detailed process is described in the below table.

GPP: 2022 Update

On August 30, 2022, the 2022 version of the GPP (GPP 2022) guidelines were published in the Annals of Internal Medicine, a crucial reference document for the publication of company-sponsored biomedical research. The GPP Steering Committee focused on numerous new topics in the 2022 update. These GPP guidelines apply to peer-reviewed or peer-oriented biomedical manuscripts, meeting presentations, posters, abstracts, and plain-language summaries. The updated version enables comprehensive guidance on ethics, transparency, planning, development, review & approval of biomedical publications, their policies, and procedures. It also covers the usage of compliant publication tools for ethical publication. The supplemental materials guide steering committees, publication plans, publication working groups, determining authorship, and documentation. Further, it includes information on alliances and working with patients within these supplemental materials.

Because of advancements in Regulatory, medical, and journal requirements, our understanding of the publication environment has progressed. The GPP3 guidelines have been modified to keep up with current developments and have defined and clarified the function, reimbursements, and enhanced duty of scientific writers in achieving a greater level. Guidelines must be evidence-based, well-understood, and generally followed to be effective. Active research, promotion, education, and monitoring are required. This mandates that scientific writers stay current with recent developments and receive specific training from recognized organizations for better knowledge and establishing the proper approach. This is required to produce high-quality documents and bridge the gap between research activity and reporting.

At Freyr, our scientific writers ensure that they are up to date with all the guidance documents and always follow GPP. Partnering with our skilled experts will ensure you are always compliant. Consult Freyr for compliance.