How Strong Medical Affairs Teams Use RWE to Achieve Impact along Patient, Disease State, Clinical and Payer Fronts

In response, pharmaceutical and medical device companies are taking rapid steps to increase the precision and speed of their RWE capabilities. This critical trend is evident in the actions taken by Medical Affairs functions across the industry, which are quickly adopting more formal RWE processes, pursuing innovation, building the total data package, and utilizing RWE earlier in the product lifecycle.

This research examine how Medical Affairs teams from leading pharmaceutical and medical device companies are using real world evidence to achieve maximum impact along patient, disease state, clinical, payer and other value fronts.

This report evaluates the role of Medical Affairs in RWE strategic decision making, oversight, evidence gap assessment, and interpretation of medical and clinical value of health outcomes. The report also delivers benchmarks around real world data sources, collection, evaluation, utilization, evidence generation, investment, and overall key performance indicators.

Study Snapshot

Best Practices, LLC engaged 45 Medical Affairs and RWE leaders from 36 companies in this research through a benchmarking survey, interviews, and a roundtable meeting discussion.

Key topics covered in this report include:

• Evolution of Real World Evidence Over the Years and Beyond
• Real World Data – Sources, Collection & Evaluation
• Medical Affairs RWE Team Structure, Reporting & Leadership
• Real World Data Utilization & Evidence Generation
• Real World Evidence Budget
• Real World Evidence KPIs

• Collaboration: Top collaborations with Medical Affairs are HEOR (82%), Clinical Dev./Ops (69%), and Market Access (61%).

• External Guidelines: Medical Organizations see a lack of nationally recognized guidelines as the top RWE barrier.

Sr. No.	Topic	Slide No.
I.	Objective
	Universe of Learning	p. 4
II.	Real World Evidence in 2020 and Beyond	p. 5
III.	Real World Data – Collection & the Total Data Package	p. 11
IV.	Medical Affairs Teams, Roles, & Responsibilities	p. 19
V.	Real World Data Utilization & Evidence Generation	p. 27
VI.	Real World Evidence Investment	p. 40
VII.	KPIs and Measuring Organizational RWE Performance	p. 47
VIII.	Appendix	p. 56
IX.	About Best Practices, LLC	p. 60

• Real word data/evidence timeline in healthcare industry
• Real world evidence in 2020 and beyond
• Expected changes in RWE investment over the next 3 years; factors that will primarily drive the changes in RWE budget
• Top areas for innovation investment
• Executive interviews around the three key elements for real world evidence success

• 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

• Improvements to Medical Affairs’ use of real world data
• Best practices followed by Medical Affairs groups in developing RWE
• Current use of real world data vs. utilization of real world data in the next two years
• Use of real world data in health economic outcomes, disease & patients insights, and payers/ formulary influencers activities
• Use of real world data in clinical trials and physicians related activities
• Emerging applications of RWE and anticipated increase in their usage over the next two years among companies using
• Success factors for highly prioritized real world data/evidence activities
• Future usage of real world data – Health economic outcomes, disease & patients, and payers/
  formulary influencers
• Future usage of real world data - Clinical Trial Related, and physicians
• Barriers limiting Medical Affairs real world evidence generation
• Use of real world data within large companies and small-mid sized companies

• Anticipated changes in RWE budget in the next three years; primary drivers of changes in the RWE budget
• Top prioritized RWE innovations for investment
• Change in RWE budget in next three years - Distribution by company size
• Total budget allocated to real world data and evidence generation in 2020 by benchmark companies
• Percentage of real world data collected from internal, external, and external (free data) sources
• Proportion of RWE budget allocated to internal RWE generation vs. externally driven RWE generation

• Use of KPIs to measure the success of real world data program
• Performance measurement areas for real world data/evidence
• Currently used publication-based KPIs
• Number of publications utilizing real world data
• Impact of currently used KPIs
• Currently used engagement-related and general KPIs
• Performance measurement areas for real world data/evidence – publications, engagement, general, and impact
• Future use of KPIs