Benchmarking Medical Publication Policies, Procedures, and Practices Across Pharmaceutical Companies C Suh 1, N Combates 1, R Matheis 1, M Ramchandani-Toddywala 1, J Frimpter 1, T Huang 2, A Weigel 3. 1 Scientific Publications, sanofi-aventis US, 55 Corporate Drive, Bridgewater, NJ 08807; 2 Fellow of sanofi-aventis US; 3 Formerly of sanofi-aventis US. Support was provided by sanofi-aventis US.
The views expressed in this presentation are our personal views and do not necessarily represent the views of sanofi-aventis US.
Background Industry sponsored peer-reviewed publications Under increased scrutiny Processes have been initiated to increase transparency Benchmarking industry processes will: Support standardization of best practices Help improve overall credibility of industrysponsored publications
Objective To establish a benchmark for pharmaceutical industry publication standards and processes
Methodology 22-item/5 domain internet-based anonymous survey Demographics Authorship Transparency Publications planning process Documentation & archiving
Recruitment & Response Sent to 63 US-based pharmaceutical companies Two waves over 2 weeks Publication department heads & managers Representative publication manager when no dedicated publications department was identified One survey per company ISMPP members 39.7% (25/63) responded
Percent Demographics 100 90 80 70 60 50 40 30 20 10 0 N = 25 12 Company Size 24 64 40 Location 52 Internal Publications Group <100 100 >1500 US US Ex-US Yes No Other to 1500 Affiliate 8 84 12 4
Percent Characteristics 100 90 80 70 60 50 40 30 20 10 0 64 Editorial Capabilities 44 80 32 Formal SOP 60 40 Follow ICMJE Editing Writing Outsource Other Yes No Yes No 92 8 N = 25
Percent Who Drives Content? 100 90 80 70 60 50 40 30 20 10 70.8 75 37.5 0 External Internal Medical Marketing Other Authors Authors Affairs All that applied were marked (n = 24) 0 8.3
Point of Author s Involvement in Development Response Percent Concept 91.6% Outline 8.3% Completed draft 0.0% N = 24
Percent Author Compensation 100 90 80 70 60 50 40 30 20 10 0 83.3 16.7 8.3 4.1 4.1 No Yes Honarium Grant Other N = 24
Author s Input Captured Response Percent* Email 79.2% Verbal exchange 70.8% Formal signed document 50% Other 25.0% *All that applied (n = 24)
Percent Documenting Authors Input 100 90 80 70 60 50 40 30 20 10 70.8 58.3 91.7 4.2 12.5 0 Emails Briefs & Outlines & None Other Synopses Drafts All that applied were marked (n = 24)
Disclosure Statement Response Percent* Yes 91.7% No 8.3 Disclosure Statement Specifics Study Funding 100% Editorial Support Funding 77.3% Medical Writer Funding 77.3 In-house writer/editor 77.3 acknowledgement *All that applied were marked (n = 24)
Percent Internal Author Limits 100 91.7 80 60 40 20 8.3 0 No Yes N = 24
Percent Publication s Committee Members and Reviewers 100 90 80 70 60 50 40 30 20 10 0 100 95.8 87.5 83.3 70.8 66.7 45.8 41.7 20.8 Committee Reviewers 70.8 50 50 Medical Biostats Marketing Regulatory Patents Other All that applied were marked (n = 24)
Strategy & Tactical Development Response Percent* Medical Objectives 87.5 Independent Gap Analysis 75.0 Editorial Board Recommendations 58.3 Marketing Objectives 54.2 Field Medical Input 54.2 Other 29.2 *All that applied were marked (n = 24)
Archiving Response Percent* In-house central archives 65.2 External communications agency 39.1 Stored locally on computer 34.8 Other 21.7 Off-site central archive 17.4 *All that applied were marked (n = 24)
Internal Auditing Process Yes, 37.5% No, 62.5% N = 24
Limitations Small sample size (N=63) Limited to ISMPP members Limited number of questions and domains Questions limited by a lack of common terminology
Next Steps Expand survey Include non-ismpp members Expand focus to include medical communication agencies May consider conducting annual survey to gather longitudinal data on current medical pubication practice
Areas for Concern and Improvement Transparency statement acknowledging: Editorial support funding Medical writer funding In-house writer/editor Publication Committee Unable to assess marketing s role Was it limited to broad strategic discussions Publications Review Marketing s involvement is a risky practice Auditing process 63% did not have an internal process Not having an internal audit is a risky practice
Conclusions First step in establishing a benchmark Respondants/ISMPP members are striving towards standardized bestpractices despite negative perceptions Room for improvement