Real World Data and Medical Affairs: Roles, Responsibilities and Key Performance Indicators

STUDY OVERVIEW

Regulators, payers, physicians and patients are increasingly demanding evidence to demonstrate the effectiveness of new medicines, and pharmaceutical companies have turned to their Medical Affairs function to generate valuable insights from real world data and to communicate it to these stakeholders.

To accomplish this, Medical Affairs leaders need to collaborate with various internal teams as well as define guidelines governing the use of real world data to avoid compliance risks. In addition, effective Medical Affairs' programs around generating outcomes data include some type of performance measurement system.

Best Practices, LLC undertook benchmarking research to understand Medical Affairs' role and responsibilities in executing real world data programs and the key performance indicators organizations use to measure the success of a real world data program.

This study contains two segments: Regional Segment: US-Only (N= 8), Global (N= 12) and Company-Size Segments: Large Companies (N= 18) and Small and Mid-sized Companies (N= 10).

KEY TOPICS

• Real World Data Governance
• Medical Affairs Collaboration with Internal Teams
• Medical Affairs Role
• Medical Affairs and its Real World Data Leadership Team
• Policies and Rules Governing Real World Data Use in Medical Affairs

• Effective KPIs to Measure RWD Success
• Number of Publications Using Real World Data
• Publication Strategy of Real World Data

KEY METRICS

• What is the governance structure for your Medical Affairs Real World Data team?
• Which internal functions does Medical Affairs collaborate with as part of its Real World Data program?
• What part of your Real World Data program does your Medical Affairs function lead, co-lead, or support?
• Which Medical Affairs teams are included within your Real World Data leadership group?
• Please explain how these Medical Affairs sub-functions are utilizing Real World Data.
• Which of the following policies and rules exist at your company to govern Real World Data use?
• What KPI(s) have you found to be most effective in measuring the success of Medical Affairs Real World Data program?
• Please estimate the number of publications utilizing Real World Data that your group has published in the last 18 months.
• How does the publication strategy of Real World Data differ from registration study data, if at all?

SAMPLE KEY FINDINGS

• Medical Affairs and Health Outcomes Teams Collaborate Most with Real World Data Group: At more than 80% of the companies, the health outcomes team is included in the Real World Data leadership group, followed by medical strategy & operations (67%), clinical trials (59%), and data management (52%). Patient advocacy and thought leader services are least involved.

METHODOLOGY

Best Practices, LLC engaged 28 Medical Affairs leaders from 23 leading biopharmaceutical companies through a benchmarking survey. More than 75% of participants serve at the director level or above.

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