Updated October 2024
Key opinion leaders (KOLs) play critical roles in many drug development life cycle stages. From initial drug discovery through R&D, clinical trials to regulatory approval, market entry, adoption and even potential new indications, a KOL in clinical research can help pharmaceutical organizations by direct development participation and drug product advocacy.
But who are they, and what roles do they play in clinical research and development?
What is a KOL?
KOLs are well-known, respected, and trusted physicians with specialized knowledge in particular fields in the medical and pharmaceutical industries. These opinion leaders provide pharma companies with advice and guidance on drug development, clinical research, regulatory compliance, marketing, and communications. They also influence their peers’ medical practice and prescribing behaviors and steer patient advocacy groups and consumers toward brands they trust.
KOLs in clinical research are frequently physician champions for clinical trials and therapeutic areas, lending them credibility. They support clinical trials by helping design successful protocols, motivate site investigators to enroll patients, compliantly collect data, and ultimately publish and disseminate clinical trial results.
Important note: KOLs for clinical research or clinical trials do not have to be physicians. Pathologists, for example, can be the right KOL for the right program at the right time as well, as can patient advocates and family members or nurse practitioners.
Want better participation in your KOL engagements? We can help. Within3 clients running KOL engagement programs on our insights management platform regularly report 100% engagement rates.
Excellence in KOL engagement for research and clinical trials begins with proper KOL mapping. Experts involved in clinical research should ideally have experience with developing clinical strategies and designing trials. They should also know the most notable clinical trials in their fields. Having this experience means they can better help to select patient populations, implement enrollment strategies, and determine trial length, consequently improving outcomes for companies in the pharmaceutical industry. By strengthening your pharma KOL engagement strategy, you can create powerful relationships with influential individuals in the healthcare space.
In terms of KOL management, other factors to consider when selecting experts to engage for clinical research include stated areas of interest, the reach of their influence, and their disposition towards working with professionals in pharmaceutical organizations.
How is the role of KOLs changing?
The role of KOLs is always evolving based on the emergence of new technology, demand for new therapies for unforeseen conditions (notably Covid-19 for example) and a changing regulatory landscape.
Digital opinion leaders
Pharma companies invest in their relationships with KOLs and key external experts (KEEs), but they should also be aware of a new type of expert: digital opinion leaders (DOLs).
These experts possess the same medical and scientific knowledge as traditional KOLs and KEEs but are digitally savvy and wield influence on social channels or other online forums. As more digital natives enter the pharma and healthcare workforce at large, this type of digital acumen will become more common.
Ethics in KOL engagement
In a peer-reviewed journal article, the term “key opinion leader” was called “somewhat Orwellian.” Is the term gaining a negative association? Some pharma organizations have introduced the similar, but less loaded, term “key external expert” to avoid any gray area. There is also an increased call for transparency around honoraria, conflict of interest disclosures, and how close some KOLs come to sales and marketing functions.
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Tips for strengthening KOL engagement in pharma
Key opinion leaders (KOLs) can help shape your product, accelerate its commercialization, and help it reach its target market more quickly and with greater adoption levels. And while the importance of leveraging KOLs in the healthcare industry isn’t new, accessing and engaging with these experts has become more complex. Industry regulations and compliance guidelines create obstacles, information channels continue to proliferate, and most physicians and researchers are busier than ever. How can teams improve pharma KOL engagement? Read our guide to learn more.
What are the roles and responsibilities of KOLs in a clinical study?
KOLs can fulfill a single specialized role in clinical research or many different roles. KOLs can help speed up patient recruitment as their patient base is typically large, and they can refer patients for participation in trials. KOLs can also work on designing clinical study protocols.
A key opinion leader may also act as a clinical trial’s principal investigator or PI. Their role as principal investigator would be coordinating the design and conduct of all clinical research activity at the study site or sites, including supervising other investigators and the study coordinator. Finally, they can also be responsible for disseminating clinical trial results.
In cases where clinical development teams use asynchronous virtual discussions to review trial data, discuss protocol development, or other trial-related activities, experienced KOLs can also be engaged as discussion moderators, using their clinical experience to guide the discussion and encourage deeper insights from their peers.
What are the benefits of including KOLs in clinical research?
KOLs are leaders in their fields who can draw on knowledge and expertise that’s valuable to any pharma company during drug development. Beyond the prospect of a KOL serving as a principal investigator in clinical research or playing a core role in a clinical trial, in the early stages, KOLs in clinical research provide guidance on target product profiles, differentiation, labeling, clinical research plans, study designs, protocols, and study sites. In the later clinical research stages, KOLs can offer advice on patient recruitment and trial results analysis and begin to educate the medical community about the drug.
Many KOLs are early adopters of novel therapies; some have even led revolutionary trials alongside their peers. In doing so, they have built strong networks of investigators and researchers for teams to tap into while conducting clinical research.
KOLs are key to disseminating clinical trial results and outcomes, which sets the stage for successful market access and eventual drug product adoption. Many KOLs are published authors in respected medical journals and have extensive experience presenting clinical data at medical congresses and conferences. Consequently, they know the best language to communicate trial outcomes and the most effective platforms to disseminate information to healthcare professionals and patient communities.
Moreover, when they serve as principals or even sub-investigators in clinical trials, they naturally boost the visibility of the trials to their peers and other healthcare decision-makers. For this reason, a virtual advisory board allows an environment for KOLs to thrive.
Ultimately the KOLs you engage for research or clinical trials should be able to contribute efficiently and effectively in a way, place and time that works for them. The goal should be for them to help your team achieve program endpoints that accelerate a therapy’s time to market or potentially open new indications.
To learn more about shifting important clinical trial activities to virtual settings, read our customer success story about a clinical team that established a single authoritative online resource center for coordinators, investigators, and researchers to view clinical trial documentation and other materials.
