Merck KGaA Publication Policy

We will strive to inform the healthcare community of the results of our clinical research by:
  • endeavoring to publish the results of all clinical trials
  • presenting the results of the research in an accurate, objective and balanced fashion
  • reviewing and approving manuscripts in a timely manner
We will ensure appropriate identification of research sponsorship by:
  • acknowledging the source of funding or sponsorship as well as providing author financial disclosure
  • information in all publication submissions
  • providing a unique identifier for each company-sponsored study in all manuscripts to assist in subsequent reviews and meta-analyses
We will coordinate the publication of results from multicenter clinical trials to ensure they are reported in a responsible and coherent manner by:
  • providing publication policies and processes to external investigators, including prestudy plans for publication/presentation and authorship guidelines
  • describing results from all study centers in the primary publication
  • referencing the primary publication in secondary publications
We will maintain open and professional relationships with our external authors by:
  • providing access to the statistical analyses and tables supporting each publication upon request
  • resolving differences of opinion about presentation and interpretation of findings through honest scientific debate
  • requesting that our investigators inform us of any plans to publish data from our clinical trials and provide drafts of those publications for our review
  • pledging to not suppress or veto publications but maintain the right to delay publication if needed to protect intellectual property
We will avoid premature or inappropriate publication by:
  • providing press releases of closed meetings of investigators, scientific meetings, or symposia that do not offer more detail about the study than was presented at the meeting
  • discussing alternative approaches with journal editors when standard publication timelines could jeopardize public health
We will avoid duplicate publication by:
  • referencing previous presentations of the data at scientific meetings.  Those presentations do not of themselves constitute duplicate publication
  • following the guidelines of scientific meetings with regard to previous presentation of the data
  • developing secondary publications (such as symposia proceedings, alternative analyses, groupings of data from more than one study) only if publication follows and references the primary publication and if they contain the unique study identifier
We will adhere to appropriate authorship criteria by:
  • using the authorship criteria of the International Council of Medical Journal Editors or those of the selected journal
  • using the same criteria for external authors and for internal Merck employees
  • acknowledging those people who made a significant contribution but do not qualify as authors
We will facilitate the publication process, provide expertise, or assist with writing/editing, if appropriate, by:
  • employing the services of internal or external professional medical writers or publication coordinators
  • providing expert opinion from a medical, communications, commercial, regulatory, legal, or other perspective
  • obtaining timely internal approval for submission
We will ensure transparency and efficiency in the publication development process by:
  • letting the authors, both internal and external, determine the content and retain responsibility for it
  • ensuring that a medical writer consult with the author(s) prior to drafting the manuscript and remain in close contact throughout development
  • giving authors and reviewers adequate time to comment on a draft of the manuscript
  • obtaining approval from all authors of the final manuscript version prior to submission
  • giving responsibility for submission and journal contact to the lead author
  • acknowledging the contribution of a medical writer or editor, if appropriate
 

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