Team working together in office analyzing data on laptop; key opinion leaders concept

Collaborating With Key Opinion Leaders in Early Clinical Trial Development: Navigating Risks and Rewards

At what point  should your key opinion leaders (KOLs) get involved in the clinical trial process?

Historically, KOLs were sought after sometime between the initiation of Phase I of a clinical trial and the launch of a completed product. However, recent evidence is shedding light on the advantages of initiating KOL engagement during the earliest phases of clinical trial development. This approach offers both risks and benefits, and the right tools become pivotal for life sciences organizations aiming to strike a balance that fosters relationships with KOLs.

Timing of Key Opinion Leaders Engagement: An Integral Decision

Early engagement of Medical Affairs and KOLs in the clinical trial process has several benefits. A 2023 article in Clinical Leader, co-authored by Uche Iloeje and peers, identifies three vital contributions KOLs and MA teams can make in the initial stages of trial development:

  • Defining areas of interest during the trial, especially those closely linked to the specific disease(s) under investigation.
  • Understanding the role of the treatment under scrutiny in the overall patient journey.
  • Identifying KOLs whose insights may prove indispensable in later stages of the study or in subsequent related research.

Regrettably, many studies do not engage key opinion leaders or other medical community members until a trial enters Phase I. This postponement carries the inherent risk of missing out on the valuable insights and wisdom that KOLs can provide, as observed by Iloeje and colleagues.

Nevertheless, there are advantages associated with later KOL engagement. Commencing KOL collaboration at a later stage enables a more refined focus on the questions posed to key opinion leaders and their role in subsequent trial phases, although it may come at the expense of the earlier benefits. Balancing the risks and benefits of early KOL inclusion can prove challenging.

Business team analyze data in report and consult for assessment and evaluation; key opinion leaders concept

Early Inclusion of KOLs: The Pros and Cons

Integrating key opinion leaders into the discovery phase of a clinical trial marks a shift in approach for many clinical trial teams, accompanied by both advantages and drawbacks.

Advantage: Paving the Path to Product Success

Traditionally, KOLs primarily collaborated with pharmaceutical companies in the pre-commercialization phases of drug development. Today, an increasing number of pharmaceutical and clinical trial teams rely on KOLs to boost engagement with providers for the entire life cycle of a product, writes Carin Alcorn at PurpleLab.

Working with KOLs throughout the product lifecycle assists pharma companies in navigating the increasingly stringent regulatory environment. Furthermore, key opinion leaders play a pivotal role in providing insights to optimize early clinical trial phases.

In a study in the Journal of Clinical Oncology, Lucas Moreno and colleagues found that early-phase trials of pediatric anticancer drugs were more effective when the trials focused on confirming doses and scheduling rather than determining effective doses and scheduling. The authors noted that early planning, including engagement of relevant KOLs, streamlines the allocation of clinical trial resources.

Advantage: Early Alignment of Messaging

Key opinion leaders earn their position by offering a reliable source of information and insight in their specialty over many years. Throughout their careers, KOLs not only cultivate professional and scientific expertise but also develop a set of core values that they express through their work.

Engaging KOLs in the early stages of clinical trial development provides life sciences organizations with more time and opportunities to ensure that a KOL’s values and reputation harmonize with the organization’s objectives. MA teams, clinical trial teams, and key opinion leaders can work together to ensure that messaging both accurately reflects shared values and meets regulatory requirements, writes Tommy Carls, Vice President of Product Management and Marketing at Proprio.

Risk: Drowning in Information

“Most KOLs are being slammed on all sides and channels by information and engagement from the pharmaceutical industry,” writes Deepak Patil, Senior Director of Medical Strategy at Aktana. The challenge for KOLs lies in discerning the information that is pertinent to their work as well as to the clinical trials they hope to support.

Engaging key opinion leaders earlier in the clinical trial process can indeed foster their involvement, yet it also carries the risk of inundating KOLs with information, potentially diluting their focused attention, to the detriment of the clinical trial team.

Risk: Delays and Unexpected Demands

Initiating KOL engagement early in the clinical trial process may occasionally feel like connecting with a KOL only to place them on hold. While their expertise is needed, a lack of proper planning can leave you with no means to keep the KOL engaged during the initial phases. Consequently, when a pertinent event arises, clinical trial teams might suddenly find themselves compelled to attract a KOL’s attention.

An inadequately planned, stop-and-start approach to KOL engagement can result in frustration and lost opportunities for both parties, warns Trina Stonner, Chief CX Officer and President at Avant Healthcare.

Colleagues discussing project using data charts and graphs; key opinion leaders concept

Creating Protocols for Early Key Opinion Leader Collaboration

Balancing potential risks and rewards is essential in incorporating KOL collaboration at early stages of clinical trial development. Many digital tools and platforms can facilitate effective communication, allowing MA teams, Medical Science Liaisons (MSLs), key opinion leaders, and clinical trial team members to strike this balance.

Preparing for a Successful Launch

The groundwork for launch success begins in the earliest stages of planning and designing a clinical trial, rendering these initial stages a suitable juncture for engaging key opinion leaders.

Although some studies indicate both MSLs and KOLs prefer to communicate in person, using a centralized digital platform to streamline information can enhance face-to-face interactions. In a centralized digital space:

  • Teams can identify providers and clarify the stages of the patient journey as they relate to the treatment under development.
  • Teams can effectively organize information and communications with KOLs.
  • Teams can formulate a consistent brand messaging strategy that authentically communicates shared values.

Scientific information, including developability properties of studied pharmaceuticals, can also be efficiently managed and shared within this environment, proving indispensable for further research and drug development, as emphasized by Monica L. Fernandez-Quintero and fellow researchers in a 2023 mAbs article.

Improving Communication

Using the right tools to foster communication among stakeholders allows for improved collaboration. KOLs can be invited to provide input on various topics from a centralized platform, allowing others to comprehend and benefit from their contributions. “These engagements let other providers borrow those best practices from one another and spread those learnings around,” says Amy Ravi, President and CEO of ExtendMed.

Additionally, preparing for in-person meetings with KOLs becomes more effective when research is conducted beforehand. Most meetings between MSLs and KOLs are brief, typically lasting around half an hour or less. By understanding the KOLs’ areas of interest before the meeting, MSLs can focus their discussions, effectively cutting through the noise to glean more valuable insights.

Establishing early communication channels fosters better collaboration between KOLs and clinical trial teams. It also streamlines communication between KOLs and MSLs or other stakeholders within the pharma company sphere. Key opinion leaders occasionally need information quickly; having a dedicated, all-in-one information management platform allows MA teams to deliver this information on a workable schedule.

When clinical trial teams and MA teams leverage the appropriate tools, they can improve engagement with key opinion leaders even in the discovery phase of trial development — leading to better trial outcomes and product launches.

Anju can help support medical affairs teams, including medical science liaisons, with KOL engagement and managing the KOL life cycle. With tools like TA Scan and TA Scan CRM, you can identify new KOLs, design their engagement strategy, and follow up with both new and known KOLs in a clean and consistent way.

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