Authorship Selection for Medical Publications at Pharmaceutical and Biotech Companies: Benchmarking Report

STUDY OVERVIEW
BENCHMARK CLASS
STUDY SNAPSHOT
KEY FINDINGS
VIEW TOC AND LIST OF EXHIBITS

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 Background	pgs. 3 to 8
	Objectives and Methodology
	Study Participants
	Participant Demographics
II.	Key Findings	pgs. 9 to 10
	Key Industry Trends
III.	Authorship Identification and Selection Criteria	pgs. 11 to 36
	Publication Practices and Selection Criteria
	Determination of an Author
	Changes in Authorship
IV.	Considerations for Authors Changing Institutions	pgs. 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

Authorship Selection for Medical Publications at Pharmaceutical and Biotech Companies

ID: POP-291

Features:

Pages: 48

Published: Pre-2019

Delivery Format: Shipped

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