Raising Phase IV Performance & Value Through Optimal MSL Involvement

Industries Profiled:
Pharmaceutical; Biopharmaceutical; Biotech; Manufacturing; Health Care; Consumer Products


Companies Profiled:
AbbVie; Alkermes; BeiGene; BioDelivery Sciences International; Inc.; Biogen; BioMarin; BTG plc; Cipla; Eisai; EMD Serono; Impel NeuroPharma; Intas; Ipsen; Janssen; La Jolla Pharmaceutical; Mayne; Melinta Therapeutics; Inc; Merck; Merck KGaA; Milestone Pharmaceuticals; Myriad Genetics; Novartis; Pfizer; Rakuten Medical; Searle; Shire; Sunovion; Taiho Pharma; Takeda Pharmaceuticals; UniQure; Vifor Pharma

Study Snapshot

Best Practices, LLC engaged 43 Medical Affairs leaders from 31 pharmaceutical and biotechnology companies in this research through a benchmarking survey and interviews.

Key topics covered in this report include:

• Phase IV study productivity and purpose
• Operational and team structures for Phase IV development and execution
• MSL involvement in Phase IV studies
• Key MSL roles in Phase IV studies
• Measuring the impact of MSL involvement
• MSL skills and competencies for Phase IV
• MSL Phase IV training

• Initiate Product-Phase IV Strategy & Goal Setting in Late Phase II: Initiation of specific study type goal setting by product is waterfall like – beginning with comparative effectiveness planning in early Phase III, and ending with expanded access study goal setting during the filing period.

• Phase IV Studies Are Overseen at the Therapeutic Area Level: 50% of companies use dedicated, cross functional, Phase IV study teams operating within a specific therapeutic area.

• Involve All MSLs in Supporting Phase IV Study Development & Execution: Nearly 90% of companies involve MSLs in Phase IV study development & execution, 2/3 of them utilize all their MSLs in some capacity for Phase IV.

• Top Performing Organizations Target RWE & Study Design for Expanded Training in the Next Year: RWE trainings will drive MSL contribution to evidence gap mapping, while the objective of study design training is to increase general knowledge.

Sr. No.	Topic	Slide No.
I.	Overview	3
	Research Overview
	Universe of Learning
	Key Recommendations
II.	Phase IV Study Objectives & Productivity	7
III.	Team Structure for Phase IV Studies	13
IV.	MSL Involvement In Phase IV Study Development & Execution	19
V.	MSL Roles In Phase IV Study Development & Execution	25
VI.	Measuring the Impact of MSL Contributions to Phase IV	42
VII.	MSL Training & Development for Phase IV	45

• Interview narrative around Phase IV studies
• Purpose of data collected in Phase IV studies
• Types of Phase IV studies benchmark companies are involved in
• Volume of Phase IV study types within benchmark companies
• Development phase during which Phase IV strategy & study type goal setting begins for a specific product

• Internal structure of Phase IV study development & execution for a given product
• Role and title of final decision maker for Phase IV study development and execution for a specific product
• Business unit leaders overseeing Phase IV – Structural flowchart
• Functions leading / supporting / informing Phase IV study development and execution within the team structure at benchmark organizations

• Formal / informal involvement of MSLs in the development and/or execution of Phase IV studies
• Span of MSL involvement in Phase IV
• Average number of Phase IV studies, marketed products, and pipeline products supported by a single MSL at benchmark companies
• MSLs in a dedicated Phase IV role supporting all products / therapeutic area-specific products
• Percentage of MSL work time allocated to Phase IV study development and execution relative to their other responsibilities
• Average ratio of MSLs with Phase IV support responsibilities to MSLs without Phase IV responsibilities
• Criteria for selecting MSLs to be involved in Phase IV

• Interview narratives on MSL alignment with Phase IV trial types
• Phase IV study activities in which MSLs are involved with at benchmark companies
• MSL role in stakeholder mapping for Phase IV studies and its importance rating
• MSL contribution to stakeholder mapping for Phase IV
• MSL role in targeting stakeholder needs for Phase IV studies and its importance rating
• MSL contribution to targeting stakeholder needs for Phase IV
• MSL role in study design, outcome measure selection, protocol development; and importance rating of MSL involvement
• MSL contribution to study design / outcome measure selection / protocol development - Structural flowchart
• MSL role in study site staff training & communication, and its importance rating
• Executive insights on MSL contribution to study site staff training & communication
• MSL role in investigator management & communication, and its importance rating
• Executive insights and narratives on MSL contribution to investigator management & communication
• MSL role in oversight of intervention delivery, data review, reporting & publishing; and importance rating of MSL involvement
• Interview narrative on MSL contribution to Phase IV study reporting & publishing

• Formal and informal measurement of MSL impact on Phase IV study development & execution
• Individual and team wide measures to gauge MSL Phase IV performance

• Current Phase IV capability rating for MSLs at benchmark companies
• Steps taken by top performers to further raise performance
• Important skills for MSLs in regards to Phase IV study involvement
• Training MSLs on skills needed to support Phase IV studies
• Phase IV study-related skills most heavily emphasized in MSL training regimens
• Areas in which top performers will increase MSL training in the coming year
• Influence of Phase IV study skills on MSL hiring decisions
• Consideration of Phase IV skills while making MSL hiring decisions
• Most essential Phase IV study skills for MSL hiring decisions
• Consideration of MSL competency with stakeholder needs (patients & HCPs) while making hiring decisions