The Need for Collaboration Between Key Opinion Leaders (KOLs) and the Pharmaceutical Industry
In order to develop innovative therapies that address unmet medical needs, pharmaceutical companies collaborate with health care professionals and biomedical research scientists. These interactions are vital for ensuring the relevance and rigor of both the clinical studies that are designed to support US Food and Drug Administration (FDA) approval of new drug products as well as the medical communications that are developed to disseminate data and educate health care providers (HCPs) and patients. Physicians and clinical researchers who are recognized as experts in their fields and who engage with the pharmaceutical industry as consultants, investigators, or educators are often referred to as key opinion leaders, or KOLs. Other terms, such as thought leader or external scientific expert, may be preferred by those who want to emphasize why these individuals’ opinions matter so much: KOLs have deep experience and knowledge in a therapeutic area and typically serve as leaders among their peers—which allows them to share informed and influential opinions with their pharmaceutical industry partners. KOLs are also uniquely positioned to help educate the medical community on new pharmacotherapies and the latest evidence-based treatment recommendations. This advocacy is critical for overcoming clinical inertia and ensuring that life-changing therapies reach the patients who can benefit from them.
Why and How Do Pharmaceutical Companies Engage KOLs?
Pharmaceutical and medical device companies form relationships with KOLs to support a range of activities, from early stage clinical development through FDA approval and beyond. KOLs may contribute to a variety of initiatives led by research and development, medical affairs, commercial, market access, and public relations teams within a pharmaceutical company. For example, KOLs may serve on advisory boards, participate in the conduct and publication of pivotal trials, support pre- and postlaunch internal training and external educational initiatives, and deliver presentations to audiences including HCPs, payers, policy makers, patient advocacy groups, and patients and their families. Although engaging KOLs allows companies to build relationships with HCPs who may have a great deal of influence over their peers’ prescribing practices, pharmaceutical companies are vigilant in separating consultancy activities, such as meetings of steering committees and advisory boards, from promotional activities, such as peer-to-peer (P2P) HCP educational speaker programs and social media activity.
Within a clinical development program, KOLs serve on steering committees to help pharmaceutical companies design research studies to yield clinically relevant data that may lead to initial approval or expanded indications for an approved drug, biologic, or medical device product. They can also advise on postmarketing studies to generate real-world evidence (RWE) that demonstrates the value of a drug product in terms of health care economics outcomes research (HEOR). KOLs are key stakeholders who can provide critical insights to contextualize conversations that the pharmaceutical company is having with the FDA. KOLs also serve as investigators in clinical trials, recruiting study subjects from among patients in their own practice to generate data for multisite trials. KOLs serve as authors on publications detailing study results, lending their insights into how to appropriately present results and draw conclusions that will be meaningful for other researchers and physicians. Lead investigators often present clinical research findings at scientific congresses in the form of posters, oral platform presentations, or symposia.
Medical affairs and commercial teams often undertake consulting arrangements with KOLs to obtain feedback and advice on research, publication, and marketing initiatives.
An advisory board meeting or other consultancy engagement may be planned with the aim of better understanding current trends in management of a given disease, clinicians’ perspectives on the range of approved and emerging products in the marketplace, variations in practice across geographical regions or clinical specialties, unmet needs in the treatment landscape, or clinicians’ wish list for an ideal product or the efficacy or safety outcomes data that they would like to see collected in future trials. Because they understand the priorities, frustrations, and potential misperceptions of practicing clinicians, KOLs can provide valuable insights on the scientific credibility of marketing messages, the best way to craft a compelling brand narrative to highlight how the product meets an existing clinical need, the patient types most likely to benefit from the drug, and the questions that prescribers will have about a product. All of these insights can inform pharma companies’ efforts to educate HCPs and patients regarding the benefits, risks, and appropriate use of their products. Although pharmaceutical marketing teams often conduct market research with practicing clinicians in order to evaluate how well different potential marketing messages resonate with their target audience of potential prescribers, KOL engagement can offer a greater range of strategic insights from experts who are best positioned to identify gaps and competitive advantages in the treatment landscape (see Figure 1).
Ethical Conduct and Regulatory Compliance in
KOL Engagement
A number of best practices to ensure that consulting relationships with pharmaceutical companies do not interfere with the independence of an HCP’s prescribing practices has been codified in The Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals, commonly referred to as the PhRMA code.1 First published in 2002, and revised in 2009 and 2019, the PhRMA code was most recently updated on August 6, 2021. These voluntary guidelines outline how pharmaceutical companies conduct ethical relationships with HCPs with respect to marketing of medicines. (A separate document, the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, addresses appropriate relationships between pharmaceutical companies and KOLs in the conduct of clinical research studies.) For example, pharmaceutical companies must contract with KOLs based on a legitimate need for services; document criteria for KOL selection; compensate KOLs at a fair market value for services provided; host events in venues conducive to the identified purpose of the meeting; offer only modest meals; and reimburse only reasonable travel, lodging, and other out-of-pocket expenses.
When KOLs present on behalf of a pharmaceutical company at an industry-sponsored symposium, product theater, national broadcast, or other live or virtual speaker program for HCP or patient audiences, they must comply with FDA regulations regarding advertisements and promotional labelling of prescription drugs and biologic products.
The PhRMA code reinforces that all pharmaceutical promotional materials should be accurate and not misleading, make claims about a product only when properly substantiated, reflect the balance between risks and benefits, and be consistent with all other FDA requirements governing such communications. All HCP speakers must comply with the sponsor’s internal policies to ensure that they provide only accurate and appropriate scientific information about the sponsor’s medicines and avoid making inappropriate comparisons with other products or unsubstantiated inferences about potential clinical benefits of a drug product. The August 6, 2021 PhRMA Code Update clarifies that invitations to speaker programs should be limited to those who have a bona fide educational need for the information presented at the program. Finally, all payments or transfers of value (eg, the value of food and beverages provided at speaker programs) from pharmaceutical companies to HCPs must be disclosed in accordance with the US Physician Payments Sunshine Act, and relationships with industry must be disclosed in accordance with institutional and publisher policies to disclose potential conflicts of interest.
Types of KOLs
KOLs are often divided into tiers based on their degrees of expertise and potential influence. Credentialing KOLs refers to evaluating the evidence for their expertise, such as publications and leadership positions noted in their CVs, and is an important part of documenting fair market value for compensating KOLs for their services.
- Internationally or nationally recognized experts who can provide strategic insights. These include physicians who:
- Hold appointments as chairs or directors of academic centers of excellence.
- Lead or contribute to the development of clinical practice guidelines and consensus statements.
- Serve on committees for professional societies and planning committees for scientific congresses and other medical meetings.
- Participate in clinical trials, as a member of a steering committee and/or as a site investigator; these may include manufacturer-sponsored phase 2 or phase 3 trials of investigational drugs as well as postmarketing RWE or HEOR studies and investigator-initiated trials.
- Serve on advisory boards or in other capacities as a consultant to pharmaceutical companies regarding their medical affairs and/or commercial strategies.
- Publish extensively in high-impact journals, including primary research articles, systematic reviews or meta-analyses, consensus statements/guidelines, invited reviews, and expert opinion/editorials.
- Provide medical expert testimony to government agencies or courts.
- Provide statements or video interviews to journalists, medical news websites, patient advocacy groups, or other organizations.
- Have a large professional network of coauthors, copanelists, fellow committee members, colleagues, or trainees.
- Hold leadership positions in regional or local professional societies.
- Engage in clinical research, for example, as a site principal investigator in multicenter, industry-sponsored trials.
- Are frequent presenters at local, regional, or national meetings, including grand rounds, continuing medical education (CME) or programs, and industry-sponsored P2P speaker programs.
- Have a strong understanding of their peers’ perspectives and their patients’ unmet needs, regarding the therapeutic area of interest.
- Digital thought leaders
- Are active on social media platforms such as LinkedIn, Twitter, ResearchGate, Doximity, Sermo, and DocMatter.
- May be national or regional-level KOLs.
These broad buckets may serve as a useful starting point, but effective KOL identification and engagement goes far beyond a standardized checklist. Each KOL has unique experiences, interests, priorities, skills, and communication styles that must be considered when inviting experts to participate in pharma-sponsored initiatives and when managing a long-term relationship with experts (see Figure 2).
The most fruitful relationships are those that allow KOLs to pursue their passions, connect with their peers in ways that they find meaningful, and contribute to the development and adoption of new treatments that they believe will substantially improve patient care.
Figure 2: Critical Tasks for Successful KOL Engagement
How to Identify KOLs
Medical communication agencies often help their pharmaceutical clients identify KOLs according to prespecified criteria related to the identified purpose for a consulting or educational initiative.
- Look at author lists on clinical practice guidelines, publications of clinical studies, and other influential publications on the relevant disease state.
- Peruse recent scientific congress programs to see who is presenting plenary lectures, symposia sessions, oral presentations, posters, or industry-sponsored activities related to the therapeutic area of interest.
- Search for recent CME in this therapeutic area. The faculty selected to lead CME activities are generally KOLs, and the biographies and financial disclosures provided under CME faculty information will give you a sense of how engaged a KOL is in the specific treatment landscape of interest.
- Watch or listen to KOLs giving lectures, interviews, or other presentations; many videos and audio podcasts are available on YouTube, on specialty-specific websites, or as on-demand content from recent virtual congresses.
- Seek referrals from trusted KOLs with whom you already work, particularly to identify up-and-coming clinician-researchers who may be eager to provide more time-consuming services that more senior KOLs do not have the bandwidth to provide.
- Consider diversity when selecting KOLs to ensure that you will obtain perspectives representing the breadth of your target audience. Consider when to recruit only physicians from a single specialty and when it would be useful to seek input from multiple specialties, primary care physicians, allied health care professionals such as nurse practitioners (NPs) and physician assistants (PAs), pharmacists, nonclinician researchers, patient advocacy community leaders, or managed care stakeholders. Consider the age, gender, and race/ethnicity of the KOLs as well as the geographical location, urban/rural setting, demographics, socioeconomics, and insurance coverage status of the patient populations they serve.
How Luminology Supports KOL Engagement
At Luminology, we understand the complexities and nuances of KOL engagement. We have ongoing partnerships with our clients to support a wide range of KOL interactions, including:
- Managing clinical development steering committees and investigator meetings.
- Publication planning and collaboration with authors on preparation of clinical trial manuscripts.
- Scientific strategy development to drive purposeful intelligence and communications initiatives for medical affairs teams.
- Engaging expert faculty for high-impact presentations such as national broadcasts and
international congress symposia. - HCP speaker identification and contracting.
- Training for HCP speakers and other internal and external stakeholders.
- Advisory board recruitment and facilitation of live and virtual meetings.
- KOL mapping to ensure that our clients’ medical affairs and commercial
initiatives reach the target audience.
Our scientific acumen, passion, customer-centric approach, and extensive industry experience combine to offer best-in-class KOL engagement support, from traditional block-and-tackle initiatives to innovative strategies that leverage cutting-edge technology platforms. Our account teams ensure seamless communication, logistical support, and compliance documentation, while our medical teams ensure productive scientific collaboration between KOLs and industry stakeholders to achieve our clients’ strategic goals. To learn more about our expertise and how we can help you build and maintain KOL relationships to enrich scientific insights and accelerate business growth, contact us.
References
- Pharmaceutical Research and Manufacturers of America (PhRMA). Code on Interactions with Health Care Professionals. Accessed August 9, 2021. https://www.phrma.org/en/Codes-and-guidelines/Code-on-Interactions-with-Health-Care-Professionals