1<!DOCTYPE html>

Products & Services Medical Affairs Data Management and Biostatics

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

ID: POP-285


33 Info Graphics

45 Data Graphics

870+ Metrics

Pages: 88

Published: Pre-2019

Delivery Format: Shipped


License Options:

Buy Now



Armed with deep scientific knowledge and focus on patients, the Medical Affairs function is uniquely poised to disseminate valuable insights harnessed from real world data to key stakeholders including regulators, payers, thought leaders, physicians and patients.

However, Medical Affairs leaders need to collaborate with various internal teams and define guidelines governing the use of real world data to avoid compliance risks.

Best Practices, LLC undertook benchmarking research to understand Medical Affairs' role and responsibilities in the execution of Real World Data program. This report establishes benchmarks around the collection, generation, analysis and dissemination of Real World Data. Also, it provides insights around the publication strategies, key performance indicators and the pros and cons of various forms of Real World Data.

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
2. Key Performance Indicators and Publications

3. Collection of Real World Data:
  • Sources of Data
4. Utilization of Real World Data:
  • Current Use of Real World Data
  • Future Use of Real World Data
  • Barriers to Use of Real World Data
5. Valuation of Real World Data:
  • Pros & Cons of Forms of Real World Data
  • Lessons Learned

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 & 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.

Table of Contents

I.Executive Summarypgs. 3-14
Research Overviewpg. 3
Respondents Backgroundpg. 4
Key Recommendationspgs. 5-6
Key Insightspgs. 7-11
Study Segmentspg. 12
Evolution and Uses of Real World Datapgs. 13-14
II.Roles and Responsibilitiespgs. 15-37
III.Key Performance Indicators and Publicationspgs. 38-44
IV.Collection of Real World Datapgs. 45-49
V.Utilization of Real World Datapgs. 50-66
VI.Valuation of Real World Datapgs. 67-73
VII.Participant Demographics and Appendixpgs. 74-86
VIII.About Best Practices, LLCpg. 87

    List of Charts & Exhibits

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

    Roles and Responsibilities
    • 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

    Key Performance Indicators and Publications
    • 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

    Collection 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

    Utilization of 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

    Valuation of Real World Data
    • 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