Good Publications Practice
Categories Scientific Communication

Communicating Company-Sponsored Medical Research: Following Good Publications Practice

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. The guidelines manage the publications that occur in scientific peer-reviewed journals as well as the presentation of posters in conferences and seminars.

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. Any data fabrication or hiding of data may affect further research and harm the overall healthcare system. Following are some of the important aspects incorporated in Good Publication Practice Guidelines.

Completeness: The research paper should contain all the data related to the study. The publication should contain both positive and negative findings. The study should also be published regardless of whether the drug under the study is investigational, is approved or licensed, or withdrawn from the market.

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, such as USFDA in the USA, UKMHRA in the United Kingdom, and CDSCO in India.

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 i.e., publishing in more than one peer-reviewed journal.

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. These may include statisticians, clinicians, professional medical writers, and researchers.

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. The agreement should include resolving any differences in data interpretation through scientific discussion.

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. Inform the author in advance about the assistance during the publication process. The sponsor or the research organization may remove confidential data related to the patient if required.

Responsibility and accountability: The authors should take responsibility and are accountable for the accuracy and presentation of data. The authors should be the sole authority to provide final approval for publication. The agreement between authors and sponsors should uphold the rights of authors in publishing accurate data without any hindrance from the sponsors.

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.

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. The publication should also mention the name of an individual or organization who has any vested interest in the findings of the research.

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. Some reputed journals do not publish the original research articles without trial registration.

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.

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.

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.

Rejection of a Manuscript
Categories Scientific Communication

5 Common Errors that Lead to the Rejection of a Manuscript

You have written your research manuscript with diligence, and now, you are ready to submit it for publication. You are worried if it gets rejected.

This is common with novice research scientists. However, if you know what makes the journal editors reject your manuscript, you can take care of such errors before submission.

So, here’s a glimpse of the common errors that can lead to the rejection of your manuscript:

1) Selection of a wrong journal

The foremost reason your manuscript gets rejected is that your research study doesn’t fit the scope of your selected journal. So, you will waste your valuable time if you select a journal out of your paper’s scope.

To avoid any mistake in selecting the right journal for your paper:

  • Carefully read the scope of the journal on its Homepage and also the section on “Instructions to Authors”.
  • Search for the similar articles in the journal.

 2) Plagiarism

Plagiarism is an act of presenting other’s work as your own. It is a serious offence in the research paper writing. Journal editors are not fools. With a plethora of plagiarism detectors, it’s easy to recognise plagiarised content in your paper.

Even self-plagiarism or reproducing your own work in another journal without citing the original can lead to the rejection of your manuscript.

Therefore, you should:

  • Always acknowledge your sources of reference
  • Not submit the results of a published literature even in a lower-ranked journal
  • Change the text copied from another source to make it different and also acknowledge the source.

3) Insignificant or false findings in the research results

The journals accept only those manuscripts that present an original research study, those which report high-quality and novel work and make significant contributions to their desired field.

Thus, if your manuscript fails to meet this criterion, or it reports a routine or trivial or false finding which doesn’t contribute significantly to the progress of Science, it will be outwardly rejected.

To avoid rejection:

  • Search the published literature related to your research topic and see their results.
  • Publish only those findings which are new or significant to your field of research.
  • Highlight the novel properties of your research study
  • Compare your article with the previous work in the field and justify your improvements with a clear statement

4) Technical errors

With one or two technical flaws, you will receive a request for revision. However, rejection occurs if it contains many technical flaws such as:

  • Discrepancy between the Abstract and the remaining manuscript
  • Study of the wrong groups
  • Wrong statistics
  • Clinically insignificant results
  • Absence of a relation between the results and their discussion
  • Contradictory/false data
  • If the conclusion doesn’t answer the research question
  • Poor use of language with grammar, spelling, and punctuation errors

There lies the importance of proofreading and editing your manuscript before you submit it to the journal.

5) Failure to follow “Instructions for Authors”

If you do not follow the “Instructions for Authors” prescribed by a specific journal, it will either delay the peer review process or lead to your manuscript rejection. So, you should always:

  • Carefully read the instructions a number of times. Best, take a print out of the journal guidelines and highlight the key instructions you have to follow.
  • Before submission, check whether you have incorporated all the instructions in your writing.
  • If you do not understand the instructions or are short of time, take help from a professional scientific editor.

Last, but not the least. Do not hurry to submit your paper to the journal publication. Take time and carefully check if you have fulfilled all the requirements as an author.