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February 11, 2021

The role of KOLs in clinical research

How do KOLs operate within clinical research, and what are the benefits of engaging them?
KOL in clinical research
Updated November 2023

Key opinion leaders play critical roles in many drug development life cycle stages. From initial drug discovery and preclinical processes through clinical trials to regulatory approval and market entry, 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 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.

Want better participation in your KOL engagements? We can help.

For 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 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 workforce, 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.


Why you’re missing 30% of the KOLs you need

Engaging the “wrong” KOLs has consequences. Find out why traditional approaches to finding expert voices no longer work in this article on how to get the right KOLs.

Tips for strengthening KOL engagement in pharma

Key opinion leaders (KOLs) can help shape your product and help it reach its target market. 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. In the early stages, KOLs in clinical research provide guidance on target product profiles, differentiation, labeling, clinical research plans, 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 were 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.

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.

Nature. Key opinion leaders — a critical perspective.
BusinessWire. What are KOLs in pharma, and why do companies need them now?
PharmExec. Being KOL-centric: More meaningful expert engagement.
PharmExec. Unlocking a new era of key opinion leader engagement: the power of digital voices.
BMJ. Key opinion leaders: independent experts or drug representatives in disguise?

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