WHAT'S IN A NAME? 

Since Clinical Expert Management (CEM) was established in 2003, there have been significant changes in the terminology due to legislation such as the Sunshine Act in the USA and the EFPIA HCP Code in Europe. In the past the use of phrases such as Key Opinion Leader (KOL) were acceptable but the implied influence is now inappropriate. 
CEM uses the term Key External Expert (KEE) to represent an individual providing expert clinical, scientific or technical services to the Client. While inter-changeable with 'Key Opinion Leader – KOL', the general trend in Industry now is to use the term 'Key External Expert'. 

IT'S ALL IN THE SCIENCE 

In recent years many clients have moved away from using phrases and concepts such as 'developing' EEs and 'measuring their growth'. It is better to talk about 'fostering collaboration and enhancing effective scientific exchange with EEs', and seeking opportunities to 'measure and assess the effectiveness of these interactions’. The impact of the Sunshine Act and other regulation means that it is no longer acceptable to use language that implies that the pharmaceutical industry is using direct, or indirect, influence to increase sales. Relationships with physicians must be transparent and any dialogue done in a balanced and fair way. The focus is on the clinical science which benefits patient outcomes. This trend has seen the growth of general medical affairs teams who often own projects rather than the traditional model of commercial teams being the main contact point for physicians. 

Glossary: 

Key Opinion Leader, Key External Expert, Therapy Area Expert and Thought Leader: These terms are used interchangeably to describe an individual providing expert clinical, scientific or technical services to the Client. While inter-changeable with 'Key Opinion Leader – KOL', the general trend in the pharmaceutical industry now is to use the term 'External Expert'. In recent years many general medical affairs teams have moved away from using terminology such as 'developing' EEs and 'measuring their growth'. It is better to talk about 'fostering collaboration and enhancing effective scientific exchange with EEs', and seeking opportunities to 'measure and assess the effectiveness of these interactions'. An External Expert is someone who has a particular expertise or knowledge that is held in respect by their peer group and who is not employed directly by the client. The External Expert should have an independent and objective perspective on their specialist environment. Any discussion with External Experts should be on the basis of level of advice that they can provide (e.g. medical scientific knowledge) rather than their perceived influence. 
 
 
Rising Star: The term 'Rising Star' is frequently used in the pharmaceutical industry, but there is no apparent industry-wide accepted definition. Meaning and use vary across companies and geographies. A Rising Star is acknowledged to be a professional working in the healthcare industry who has the potential to be recognised as an External Expert. Rising Stars can work in any discipline relevant to healthcare and need not reflect purely clinicians or scientists (i.e. they may be healthcare policy makers, regulators, professionals involved in Health Technology Assessments, or technology horizon scanning activities). Across all disciplines, a Rising Star can be defined as a future EE with a growing reputation as an expert across a variety of EE attributes. Assessment of the effectiveness (quality and outcome) of these interactions - against the various EE attributes - will allow for meaningful measurement of engagement, whether it is continuing to evolve, showing signs of levelling off (plateauing) or even declining.  
 
New entrant: This is CEM's preferred term for a potential Rising Star who has not yet been shown to be a future External Expert. They may be someone whose clinical / research focus has shifted from another area into the one under scrutiny. Until their demographics are confirmed it is not possible to describe them as a Rising Star. 

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