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Authorship Selection for Medical Publications at Pharmaceutical and Biotech Companies

ID: POP-291


6 Info Graphics

34 Data Graphics

210+ Metrics

Pages: 48

Published: Pre-2019

Delivery Format: Shipped


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Medical publications are an important and credible means of communicating relevant scientific information about a company's existing and pipeline products to healthcare professionals. However, pharmaceutical and biotechnology companies encounter potential gray areas when it comes to authorship selection for articles and handling author transitions to another company or institution.

Best Practices, LLC undertook this benchmarking research to help pharmaceutical and biotechnology companies effectively shape their publication policies. In particular, this report delivers benchmarks around authorship selection criteria, selection process and author transition to other organizations.

Industries Profiled:
Pharmaceutical; Biopharmaceutical; Biotech; Manufacturing; Consumer Products; Diagnostic; Medical Device; Chemical; Health Care

Companies Profiled:
Abbvie; Akebia Therapeutics; Allergan; Alnylam Pharmaceuticals; Astellas; AstraZeneca; Bayer; Bioventus; Celgene; Daiichi Sankyo; Envision Pharma Group; Ferring Pharmaceuticals; Genentech; Heel; Johnson & Johnson; Merck; Novartis; Roche; Sanofi Genzyme; Shionogi Inc.; Shire; Takeda Pharmaceuticals

Study Snapshot

Best Practices, LLC engaged 23 publication professionals from leading biopharmaceutical companies and a publication services consultancy in this benchmarking research.

Key topics covered in this report include:

1. Selection Criteria and Process

  • Criteria and process for different types of publications
  • Defining, tracking, and recording author contributions
  • Process for internal vs. external authors

2. Author Transitions
  • Guidance for transitioning authors
  • Joining a competitor vs non-competitor
  • Guidance for transitioning KOLs

Key Findings

Sample key insights uncovered from this report are noted below. Detailed findings are available in the full report.

1. All use ICMJE authorship criteria but many go beyond it
    • All companies adhere to ICMJE, but 75 percent define “substantial” contributions and about half go beyond ICMJE.
    • Those who use only ICMJE consider its criteria fair, sufficient and comprehensive.

2. Key differences in authorship decision-making process for small and large companies
  • Smaller companies are more likely to create separate processes for different study types and deploy steering committees in every trial. Larger companies are more likely to provide guidance for transitioning authors.

Table of Contents

I.Study Backgroundpgs. 3 to 8
Objectives and Methodology
Study Participants
Participant Demographics
II.Key Findingspgs. 9 to 10
Key Industry Trends
III.Authorship Identification and Selection Criteriapgs. 11 to 36
Publication Practices and Selection Criteria
Determination of an Author
Changes in Authorship
IV.Considerations for Authors Changing Institutionspgs. 37 to 46
Guidance on Removing an Author
An Author Leaving for a Competitor/Non-Competitor
A Former Employee as a Lead Author
Presenting at a Congress
Authorship Rights in Employment Contracts

List of Charts & Exhibits

Author Identification and Selection Criteria
  • Publication practices followed by benchmark partners
  • Reasons why informal group of trial contributors is not created
  • Reasons for not differentiating early research and R&D publications
  • Reasons why formal steering committees are not created for every trial
  • Reasons why a ratio/number of internal to external authors is not used
  • Reasons for not differentiating internal and external authors during selection
  • Reasons for not differentiating author selection for publications with alliance partners
  • Reasons for not differentiating author identification/selection for HEOR publications
  • Selection criteria employed to determine authorship on all publications
  • Reasons for not defining “substantial” authorship contributions in ICMJE to help guide author identification
  • Reasons for not tracking and recording individual contributions for meeting authorship criteria prior to the start of publication development
  • Reasons for not using additional criteria other than ICMJE
  • Reasons for not using separate standards to track if ICMJE criteria were met for early research or R&D publications
  • Reasons for not using a set of separate standards to track if ICMJE criteria were met for HEOR publications
  • Group responsible for determination of an author
  • Group responsible for determining changes in authorship such as addition or removal of individuals
  • Criteria included in corporate guidelines and policies, in addition to ICMJE and GPP3 publication guidelines
  • Allowed changes to the author list
  • Permit for authorship changes
  • Approval of change in authorship

Considerations for Authors Changing Institutions
  • Guidance on removal of an author from publication
  • Guidance when an author is leaving for a competitor/non-competitor
  • Circumstances under which a former employee is allowed to remain a lead author after leaving the company
  • Stage of publication at which a former employee is allowed to remain a lead author
  • When can an internal author who has left the company present publication data at a congress?
  • Section in employment contract clarifying authorship rights