Understanding the Changing Landscape of Real World Evidence Generation: Non-Safety Registries

STUDY OVERVIEW

Real World Evidence (RWE) is a key driver of formulary and reimbursement decisions by both public and private payers and is an important focus area for global regulators. Consequently, the pharmaceutical industry has been boosting internal RWE capabilities and is increasingly outsourcing to vendors specializing in RWE generation.
Non-Safety Registries, which in this research encompass four RWE study methods, are utilized by many pharma companies. Best Practices, LLC conducted this study to gain insights into current and future utilization of these four study methods (Disease Registries, Product Registries (Not including Vaccine Registries), Pregnancy Registries, Vaccine Registries). In addition, the study presents benchmarks on the data collection methods used, the level of outsourcing used and valued vendor traits for these study types.

KEY TOPICS

• Executive Summary: Methodology, Participants, Recommendations & Key Findings
• Overview of Non-Safety Registries Studies Utilization, Data Collection Methods & Outsourcing
• Non-Safety Registries: Disease Registries, Product Registries (Not including Vaccine Registries), Pregnancy Registries, Vaccine Registries

KEY METRICS

• Note: The questions below were asked for each of the 4 types of Non-Safety Registries Studies examined in this study:Disease Registries, Product Registries (Not including Vaccine Registries), Pregnancy Registries, Vaccine Registries
• What is your level of awareness/utilization regarding Disease Registries?
• Do you believe your usage of Disease Registries will increase/decrease/stay same?
• How many Disease Registries did you conduct in the past year?
• In 2020, how many Disease Registries do you anticipate doing?
• What methods of data collection do you use for Disease Registries?
• In 2020, what methods of data collection will you use for Disease Registries?
• To what extent do you outsource Disease Registries?
• For Disease Registries, what is the most critical characteristic you desire in a vendor?
• If you have a preferred vendor for Disease Registries, please identify them

SAMPLE KEY FINDINGS

• Non-Safety Registry Studies: Data collection methods centered around primary data for 3 of 4 study types in this category: More than the other categories, Non-Safety Registry studies utilize primary data: Disease Registry (64%), Product Registry (50%), and Pregnancy Registries (80%). The lone Vaccine Registry respondent uses a mix of primary and secondary data.

METHODOLOGY

This study engaged 25 leaders within 19 global organizations with deep experience in managing Real World Evidence generation at top pharmaceutical companies.

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