Understanding the Changing Landscape of Real World Evidence Generation: Observational Studies

STUDY OVERVIEW

Observational studies, which in this research encompass five 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 five study methods (Post-authorization Safety Studies, Drug Utilization Studies, Prospective Observational Studies with HEOR Objectives, Post-authorization Efficacy studies and Medical Record Abstractions). 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 Observational Studies Utilization, Data Collection Methods & Outsourcing
• Observational Studies: Post-authorization Safety Studies, Drug Utilization Studies, Prospective Observational Studies with HEOR Objectives, Post-authorization Efficacy studies and Medical Record Abstractions

KEY METRICS

• Note: The questions below were asked for each of the 5 types of Observational Studies examined in this study: Post-Authorization Safety Studies, Drug Utilization Studies, Prospective Observational Studies with HEOR Objectives, Post-Authorization Efficacy Studies and Medical Record Abstractions
• What is your level of awareness/utilization regarding Post-Authorization Efficacy Studies?
• Do you believe your usage of Post-Authorization Efficacy Studies will increase/decrease/stay same?
• How many Post-Authorization Efficacy Studies did you conduct in the past year?
• In 2020, how manyPost-Authorization Efficacy Studies do you anticipate doing?
• What methods of data collection do you use for Post-Authorization Efficacy Studies?
• In 2020, what methods of data collection will you use for Post-Authorization Efficacy Studies?
• To what extent do you outsource Post-Authorization Efficacy Studies?
• For Post-Authorization Efficacy Studies, what is the most critical characteristic you desire in a vendor?
• If you have a preferred vendor for Post-Authorization Efficacy Studies, please identify them

SAMPLE KEY FINDINGS

• Observational Studies: Respondents typically use a mix of in-house & outsourcing for 4 of 5 studies in this category: The four RWE study types in this category where most respondents use a mix of in-house and outsourcing are: Drug Utilization, Post-Authorization Efficacy, Post-Authorization Safety, and Prospective Observational w/ HEOR. Meanwhile, most respondents use only outsourcing for Medical Record Abstractions, although many use a mix too.

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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