The document discusses guidelines for good publication practice in company-sponsored medical research. It outlines recommendations for publishing research studies sponsored by pharmaceutical and biotech companies. Key aspects of the guidelines include completeness in reporting all data findings, following relevant regulatory laws and ethical guidelines, ensuring collaboration between authors, and disclosing conflicts of interest. Adhering to these guidelines aims to bring transparency and authenticity to published medical research.
3. Introduction
The Good Publication Practice guidelines aim
to bring transparency and authenticity to the
data that is published in company-sponsored
medical research. The guidelines provide the
roadmap for ethical publication and to
incorporate all the data which is required for
evolving further research.
4. Good Publication Practice
Guidelines
The Good Publication Practice Guidelines provide
recommendations about the publications of research studies
that are sponsored by the pharmaceutical, biotechnological,
and diagnostic companies. These guidelines are important,
keeping in mind the very fact that such publications need to
have a high standard of ethics and transparency. Many such
publications show a path for future research.
5. Following are some of the
important aspects incorporated in
Good Publication Practice
Guidelines.
6. Completeness: The research paper should contain
all the data related to the study. The publication
should contain both positive and negative findings.
Regulatory laws: The sponsors and researchers
should follow all the relevant regulatory laws in the
geographical area where the study is conducted. The
study should also follow the guidelines of the food
and drug administration department
7. Ethical guidelines: Maintaining ethical standards are
essential while conducting a research study. The
study should follow ethical guidelines at all times
during the study. The author and sponsor should
avoid duplicate publication
Collaboration: A collaboration should be present
between all the authors and contributors. The
research study should reflect the collaborative efforts
of all the people involved in the study.
8. Roles and responsibilities: The sponsors should fix
the roles and responsibilities of each contributor
through a written agreement. The sponsor should
define the role before the process of research writing
starts.
Access: Data is important while writing the research
paper. The sponsor should ensure that the author has
access to complete and correct data. The agreement
between the author and sponsor should disclose the
publication process and role of the sponsor in
reviewing the publication.
9. Responsibility and accountability: The authors
should take responsibility and are accountable for the
accuracy and presentation of data.
Name of the contributors: The publication should
contain the name of each author who contributes to
the publication of the research paper. It is important
to mention the level of contribution of each
contributor, such as medical writer or statistician, to
avoid any ambiguity.
10. Sponsor details: The publication clearly mentions
the sponsor detail. The publication and presentation
should also contain the role of the sponsor in
funding, analysis, and execution of the research.
Conflict of interest: Disclosing the conflict of
interest in the publication increases its authenticity.
The authors and the contributors should clearly state
if there is any conflict of interest.
11. Trial registration: The registration of the trial with
the appropriate authority adds value to the research
study. It signifies that all the regulatory laws and
ethics are followed while conducting the study.
Plagiarism: The authors should avoid any
plagiarism. They should ensure that the publication is
their original work. However, if there is any need to
incorporate the copied material, the author should
take due permission and properly acknowledge the
original writer.
12. Hiring a professional medical writer: Professional
medical writers are experts in writing the manuscript.
The medical writers assist the authors in writing the
medical manuscript completely, accurately, and on
time. They are of great help in cases where the
authors have limited knowledge about the
presentation of data and other publication
requirements.
13. Conclusion
The Good Publications Guidelines pose various
requirements for both the authors and the sponsors. These
requirements include complete and accurate data
presentation, trial registration, responsibility and
accountability of authors, acknowledgement of authors, and
details of sponsors.
