How Medical Affairs Teams Use RWE: Data Collection and Roles

STUDY OVERVIEW

The power of real world evidence (RWE) has significantly increased demand for outcomes and other RWE insights across the entire healthcare value chain, from thought leaders and HCPs to payers and regulatory bodies.

In response, pharmaceutical and medical device companies are taking steps to increase the precision and speed of their RWE capabilities. This trend has impacted Medical Affairs since pharma is relying on this function to lead and guide many aspects of RWE utilization.

This study evaluates the role of Medical Affairs in real world data collection and evaluation. It also examines the roles and responsibilities of Medical Affairs in RWE. This study will inform Medical Affairs leaders regarding the current trends and practices of medical regarding RWE generation and governance.

KEY TOPICS

• Executive Summary
• Real World Evidence in 2020 and Beyond
• Real World Data – Collection & the Total Data Package
• Medical Affairs Teams, Roles, & Responsibilities

KEY METRICS

1. Real World Data – Collection & the Total Data Package

• Percentage of companies using different sources of real world data
• Percentage change in use of specific sources of real world data from 2017 to 2020
• Change in proportion of external and internal RWD collected from 2017 to 2020
• Challenges faced by Medical Affairs in collecting and evaluating the use of real world data
• Sources of internal and external real world data
• Challenges faced by Medical Affairs groups of large companies in collecting and evaluating the use of real world data
• Challenges faced by Medical Affairs groups of small-mid size companies in collecting and evaluating the use of real world data

• Real world data/evidence governance structure within benchmark companies
• Reporting structure for Medical Affairs real world data/evidence team
• Primary and secondary collaborators of Medical Affairs as part of its real world data/evidence program
• Lead, co-lead and support roles of Medical Affairs function in various aspects of the real world data/evidence program
• Core members of the medical-based RWE leadership group
• Contribution of the medical teams in RWE leadership group across the RWE cycle

• Leadership/Governance/Teams: Medical leadership/Co-leadership across RWE processes is essential for ensuring the medical and clinical value story are prominent internally and externally. Across compositions, a majority of medical-RWE teams report solely to medical executives.

Best Practices engaged 45 industry leaders across 36 companies to discern RWD/E best practices, trends, and Medical Affairs optimal role.

Industries Profiled:
Pharmaceutical; Consumer Products; Health Care; Medical Device; Biotech; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
Novartis; Merck; EMD Serono; Roche; AstraZeneca; Astellas; Merck Serono; Takeda Pharmaceuticals; Sanofi; Boehringer Ingelheim; Teva Pharmaceutical Industries Ltd; Eisai; Jazz Pharmaceuticals; Grifols; Edwards Lifesciences; OTSUKA; Vertex Pharmaceuticals; Terumo Corporation; UCB Pharma; Avanos Medical; GE Healthcare; Fidia; Intercept; CSPC Pharmaceutical Group; Invitae; Cipla; Proteus Digital Health; Agios; Almirall; Adamas Pharmaceuticals; Dendreon; Purdue Pharma; Searle; ADC Therapeutics; Mitsubishi Tanabe Pharma; Melinta Therapeutics; Inc

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