MEDICAL AFFAIRS MEASUREMENT: IDENTIFYING COMPLIANT KEY PERFORMANCE INDICATORS Gary Kaplan, M.A., Vice President, Medical Affairs Research, Clinical SCORE
Once upon a time, it was easier to measure success. Under the old pharmaceutical sales paradigm, it was all about quantitative measures like number of calls. But today s consultative model is far more nuanced. When it comes to gauging the effectiveness of Medical Affairs (MA) teams, the industry seems to struggle with identifying the right key performance indicators (KPIs). One of the key challenges has been finding a non-monetary way to measure performance while maintaining regulatory compliance. Outcomes-based KPIs may be the answer. THE ROLE OF MEDICAL SCIENCE LIAISONS In today s emerging Medical Affairs environment, the responsibilities of medical science liaisons (MSLs) tend to vary from one company to another. Generally, they have two key assignments: Providing internal stakeholders with insights into key opinion leaders (KOLs ) current views on science/medicine in the market Serving as scientific experts to the medical community Although MSLs tacitly support a company s approach to fighting a disease state, the information they provide to health care professionals (HCPs) and identified KOLs must be unbiased. MSLs objectivity must be beyond reproach. Information on a drug s clinical success must be based on science, not marketing. It must include both the efficacy successes identified in trials and any identified safety concerns. Compliance regulations, which govern the role of medical affairs teams, ensure that MSLs refrain from providing anecdotal and/or biased research results to their external experts. MSLs must walk the fine line between educating a KOL or HCP about a product and marketing that product. 3
COMPLIANCE POSES MEASUREMENT CHALLENGES MSLs are consultants, not sales representatives, and so traditional approaches aimed at measuring the effectiveness of their ability to influence a KOL to accept a specific scientific approach to a disease state will not pass muster with compliance groups. Historically, to gauge detail teams sales campaigns, companies carried out researched programs that measured the level of prescriptions written pre- and post-campaign. Today, a new paradigm is essential in order to allow corporate management to fully understand the extent to which their MA teams are succeeding. It s critical to know: How do KOLs in a given specialty view the advantages or disadvantages of various medications mechanisms of action? Given a specific diagnosis, do opinion leaders agree on a common approach to treatment? Are HCPs loath to prescribe medications with certain mechanisms of action due to concern for patient non-compliance? How do the questions above relate to a company s MSL staff? Without some type of meaningful and comprehensive MA key performance indicator (KPI), it s moot. Companies will continue to fly blind, having no conclusive evidence of their MA team s effectiveness. HOW CLINICAL SCORE CAN HELP Clinical SCORE has developed a proprietary approach to assessing the performance of medical affairs teams without specifically matching an opinion leader s views to any specific MSL or MSL team. This compliant technique: Objectively measures opinion leaders decision-making in various specific medical situations Tracks decision metrics over time Assesses how external events in the marketplace such as product or competitor pre-launch, launch or post-launch impact strategic decisions 4
The research does not name any company or competitor, specific product or drug, or MSL team. Each respondent receives a series of distinct medical scenarios created specifically for a disease or ailment in the KOL s therapeutic area. Each of the options displays patient demographics, disease severity and the specifics of either lab results or the patient s current medical history. These variables are altered with each successive question. This approach is completely agnostic, thereby ensuring that the research meets compliance standards. Developing outcomes-based KPIs requires an initial meeting with Medical Affairs senior managers and all key Medical Affairs compliance officers in order to introduce the process and answer any questions related to compliance. Following compliance approval, the questionnaire scenarios are developed with the assistance of a paid experienced physician or the company s own Medical Officers within each therapeutic area under study. Once they have created the series of scenarios, conducting the research is a straightforward process. OBTAINING RESEARCH RESULTS We provide research results via our KPI Konsole, which accomplishes multiple goals. Our unique format makes it possible to: Objectively identify the thinking of opinion leaders within any given therapeutic area on such topics as the perceived effectiveness of different mechanisms of action, the perceived patient compliance based on different mechanisms of action, the use of biologics, etc. This will enable Medical Affairs teams to better understand how best to tailor their presentations to opinion leaders. Determine the quantitative changes that may occur prior to the launch of the company s new drug, at product launch and in the six months to a year after launch. This information will provide Medical Affairs teams with the means to assess the effectiveness of their MSL teams. 5
Determine the quantitative changes that may occur prior to a competitor s new drug launch, at launch and six months to a year later. This will enable medical affairs teams to assess the effectiveness of competitive MSL teams. Provide a weighted score across all scenarios to understand the impact of external events on a company s desired result, if Compliance approves this metric. As the role of Medical Science Liaisons becomes increasingly important, compliant outcomes-based KPIs can play a key role in measuring the effectiveness of MSL teams. To learn more, visit MedicalAffairsPerspectives.com. Gary Kaplan is Director of Research and Analysis for Clinical SCORE. His main areas of expertise are sample design, study design and data analysis. He has extensive experience, having spearheaded and directed survey research in more than 15 industry sectors, including commercial pharmaceuticals, operational pharmaceuticals, converged technology (IT and telecommunications), expedited shipping and political polling. He has served as Director of Analysis at Consumer/Industrial Research Services, Chief Statistician at Chilton Research Services, Director of the Advanced Methods Group at TNS US and the US director of Leger Marketing. Mr. Kaplan has presented design approaches and survey results worldwide to audiences in 20 countries and at academic institutions including McGill University, Montreal, Canada; Emory University, Atlanta, Georgia; and the University of Washington in Seattle. His articles have appeared in Advertising Age, The Journal of Marketing Research and Quirks Marketing Research Review, and he has authored white papers for the Advertising Research Foundation. He holds a Bachelor of Science degree in Psychology and a Master of Science degree in urban Studies, both from Tulane University in New Orleans, Louisiana, and a Master of Science in Applied Statistics from Temple University, Philadelphia, Pennsylvania. 6