Best Practices in Biopharmaceutical Medical Publications: Authorship Selection Criteria and Process

STUDY OVERVIEW

Scientific publications is a critical activity for the pharmaceutical industry - it is the principal way that physicians learn scientific/medical information about a company's existing and pipeline products. But biopharmaceutical companies sometimes encounter gray areas when it comes to authorship selection for articles.

Best Practices, LLC undertook benchmarking research to examine the industry's approach to authorship selection. In particular, this study reviews the standards, processes and rationale of critical authorship selection and retention decisions. Publications leaders can use this research to shape their publication policies to avoid uncertainties and delays.

KEY TOPICS

• Criteria and Process for Different Types of Publications
• Defining, Tracking, and Recording Author Contributions
• Process for Internal vs. External Authors

KEY METRICS

• Please clarify why you don't create an informal working group of trial contributors to oversee author determination
• Please clarify why you don't have a separate process for author identification/selection for early research or R&D publications
• Please clarify why you don't have a separate process for author identification/selection for HEOR publications
• Who ultimately determines who will be invited to be an author?
• What changes to the author list are allowed?
• Who approves a change in authorship?

SAMPLE KEY FINDINGS

• 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.

METHODOLOGY

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

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