Real World Data and Medical Affairs: Best Practices in Maximizing its Use and Producing Results

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


Companies Profiled:
Abbott; Abbvie; Allergan; Ambry Genetics; AstraZeneca; Bayer; Biogen; Celgene; EMD Serono; Ferring Pharmaceuticals; Genentech; Incyte; Kyowa Kirin; Merck; Novartis; Pfizer; Roche; Sanofi; Santen; Sunovion; Takeda Pharmaceuticals; Theravance; ViiV Healthcare

Study Snapshot

Best Practices, LLC engaged 28 Medical Affairs leaders from 23 biopharmaceutical companies through a benchmarking survey. More than 75% of participants are at the director level or above.
Responses are presented into 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 covered in this report include:

1. Structure and Oversight:

• Real World Data Governance
• Medical Affairs Role
  

• Sources of Data
  

• Current Use of Real World Data
• Future Use of Real World Data
• Barriers to Use of Real World Data
  

• Pros & Cons of Forms of Real World Data
• Lessons Learned

• 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 & thought leader services are least involved.
  
• Most of the Collected Real World Data Falls Under Purchased External Data: On average, 56% of Real World Data is purchased from external sources, while a small amount of data is available free on external sources. More than a third of Real World Data comes from internal sources.

I.	Executive Summary	pgs. 3-14
	Research Overview	pg. 3
	Respondents Background	pg. 4
	Key Recommendations	pgs. 5-6
	Key Insights	pgs. 7-11
	Study Segments	pg. 12
	Evolution and Uses of Real World Data	pgs. 13-14
II.	Roles and Responsibilities	pgs. 15-37
III.	Key Performance Indicators and Publications	pgs. 38-44
IV.	Collection of Real World Data	pgs. 45-49
V.	Utilization of Real World Data	pgs. 50-66
VI.	Valuation of Real World Data	pgs. 67-73
VII.	Participant Demographics and Appendix	pgs. 74-86
VIII.	About Best Practices, LLC	pg. 87

• Real Word Data Timeline in Healthcare Industry
• Understanding Real World Data (RWD) Use in Medical and HEOR Decision-Making

• Real World Data Governance
• Governance Structure for Medical Affairs Real World Data Team
• Medical Affairs’ Collaboration with Internal Functions as Part of its Real World Data Program
• Medical Affairs’ Lead / Co-lead / Support Role in Various Aspects of Real World Data Program
• Groups with Whom Medical Affairs Co-Leads or Supports Different Real World Data Activities
• Medical Affairs Teams Included within Real World Data Leadership Group
• Medical Affairs Sub-functions Responsible for Real World Data Program Ranked in Order of Priority
• Utilization of Real World Data by Different Medical Affairs Sub-functions
• Policies and Rules Used to Govern Real World Data Use in Medical Affairs
• Medical Affairs and its RWD Leadership Team

• KPIs Used to Evaluate Real World Data Program Success
• Most Effective KPIs in Measuring the Success of Medical Affairs Real World Data Program
• Number of Publications Utilizing Real World Data Published by Participants
• Publication Strategies of Real World Data

• Challenges in Collecting and Evaluating the Use of Real World Data
• Percentage of Real World Data Collected Under the Following Categories - Internal (Self-generated Data), External (Purchased Data) and External (Free Data)
• External Vendors Hired by Participants for Collecting Real World Data

• Common Uses of Real World Data by Medical Affairs
• Phases in Which Different Types of Real World Data is Utilized by Medical Affairs
• Anticipated Use of Real World Data by Medical Affairs in the Next Two Years
• Barriers Limiting the Use of Real World Data by Medical Affairs
• Tactics to Improve Use of Real World Data
• Use of Real World Data in Supporting Medical Affairs Strategy

• Valuable Real World Data Activities for Medical Affairs' Success
• Pros and Cons of Various Forms of Real World Data
• Key Lessons Learned from Utilizing Real World Data
• Future Use of Real World Data by Medical Affairs