Raising Phase IV Performance & Value Through Optimal MSL Involvement: Objectives & Team Structure

The involvement of medical science liaisons (MSLs) in the development and execution of Phase IV studies is particularly important, considering that Phase IV is a critical means to generate real world data that serves the needs of vital stakeholders such as payers and regulatory bodies.

As a result, pharmaceutical and biotech companies are driving their efforts toward maximizing the impact of MSLs on Phase IV studies.

Best Practices, LLC conducted this benchmarking research to probe how leading pharmaceutical and biotech organizations are raising Phase IV performance and value through optimal involvement of MSLs. This study characterizes the MSL contributions most essential to Phase IV and delivers benchmarks around the field team structures that help maximize MSL impact on Phase IV studies.

KEY TOPICS

• Phase IV Study Productivity & Purpose
• Operational & Team Structures for Phase IV Development & Execution
• MSL Involvement in Phase IV Studies

• For each of the listed Phase IV study types, how many were company involved in during 2018 (Started, ongoing, completed) for your principal therapeutic area?
• For a given product at your company, when during development does Phase IV strategy & study type goal setting begin for a specific product?
• For a given product at your company, what is the internal structure for Phase IV study development & execution?
• What is the role of the final decision maker for Phase IV study development and execution for a specific product?
• What roles lead, support, or inform Phase IV study development and execution within the team structure at your organization?
• Are the MSLs in a dedicated Phase IV role, or are Phase IV activities performed in addition to their normal role?
• What is the average number of Phase IV studies, marketed products, and pipeline products supported by a single MSL at your company?
• On average, what percent of an MSL’s work time is allocated to Phase IV study development and execution relative to their other responsibilities?

• Emphasize Clinical Effectiveness for Phase IV Studies: Clinical effectiveness is the primary focal point of Phase IV data generation across organizations. Patient Quality of life is the second.
• Involve All MSLs in Supporting Phase IV Study Development & Execution: Nearly 90% of companies involve MSLs in Phase IV Study Development & Execution, 2/3 of them utilize all their MSLs in some capacity for Phase IV.

Best Practices, LLC engaged 43 Medical Affairs leaders from 31 pharmaceutical and biotechnology companies in this research through a benchmarking survey and interviews.

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