The Role of Market Research in the Reporting of Adverse Events by Third-Party Vendors

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"The Role of Market Research in the Reporting of Adverse Events by Third-Party Vendors"

Study Overview

As the U.S. Food and Drug Administration sharpens its focus on safety, there is more attention on post-market surveillance of products through adverse event (AE) reporting. This benchmarking study examines market research’s role in reporting adverse events uncovered by third-party vendors, in particular those in market research and analytics roles.
The study data and findings provide insight to market research and business intelligence executives and managers about how the pharmaceutical industry applies FDA regulations that require pharmaceutical manufacturers to be responsible for reporting adverse events relating to their drugs on market. The study includes FDA regulations surrouding AE reporting and information from a Best Practices, LLC interview with an FDA compliance officer.

Key Topics

• Reporting Requirements for Market Research and Vendors
• Working with Third-Party Vendors on AE Collection
• Physician Guidance & Support
• Impact of Vendor Reporting
  

• Company operations with SOPs for Adverse Event (AE) Collection
• Market Research’s AE Reporting Protocol
• Vendor AE Reporting Protocol
• Group Responsible for AE Collection
• How Vendors Report AEs
• What Company Groups do Vendors Report AEs to
• Percentage of AEs from Vendors
• Percentage of AEs Expected from Vendors in next year
• How Vendors Train for AE Collection
• Vendor Support for AE Collection
• Opinion on Vendor AE Collection/Reporting
• Reporting Guidance for Physicians Participating in Vendor Market Research
• Whether Physicians Compensated for Market Research Participation
• Does Physician Compensation Compromise AE reporting?
• Impact of AE Reporting by Physicians in Market Research Studies
• Risk of Misreporting Physician Comments by Vendors
• Impact of Requiring Vendor Collection of AEs
  

• While the FDA has stated that any company representative who has the potential to collect AEs from physicians and patients is required to report such data, the industry seems divided on what to do. About half the benchmark partners have taken steps to have third-party vendors collect AEs while the other half has not.
  
• All the partners report that less than 5 percent of their adverse events reports come from third-party market research vendors. Only one company expected an increase in reporting to 6-10 percent in the next year.
  

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