If you work for a clinical trial sponsor or a clinical research organization (CRO), at one point or another you will need to work with a Key Opinion Leader, (KOL). A KOL is essentially a physician champion for your clinical trial and therapeutic area. Generally speaking, a KOL is a well-respected member in the physician community, a published author on peer reviewed journals and has experience presenting clinical data at scientific congresses. For this reason, a KOL can add considerable credibility to your clinical trial by helping you develop a robust clinical trial plan, motivating site investigators to enroll patients, collect data in a compliant manner and ultimately publish clinical trial results.
Knowing how to work with KOLs is extremely important. Unfortunately KOL management often left up to senior executives or management within an organization. However each one of us has the power and ability to positively impact KOL relationships. In this two-part blog post, I will share tactical and strategic ideas on how to work with KOLs.
Tactical ideas are usually easy to implement. The hard part is being aware of these needs and acting on them in a timely manner.
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Use Technology To Schedule Meetings
As the acronym KOL suggests, you would reach out to them when you need an opinion about some clinical trial issue or have a clinical strategy question. The first reactive response is to send an email to the physician or her administrative assistant to find out their availability and schedule a meeting. Once we know the KOLs availability we work with key stakeholders, such as study team members and management, to confirm their availability with the date and time provided . If schedules don’t align, another email is sent. This turns into this circular email cycle till we find a date and time that works for most people involved. The issue with this approach is that it is confusing and time consuming!
This is where technology comes handy. Leverage software tools such as Doodle to identify meeting dates and times that work for everyone. Doodle reduces the email back-and-forth and saves valuable time and energy.
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Create A Meeting Agenda
KOLs are busy people, usually with full-time responsibilities of treating patients or working on scientific research. KOLs are interested in your clinical trial or medical technology. However they can allocate limited time as most of them have other commitments.
A simple and powerful tool to make the best use of KOL time is to develop a well-thought meeting agenda. I personally don’t recommend leading any KOL meeting in an absence of a meeting agenda. An agenda will help guide the discussion with the KOL and ensure you have a focused discussion. Depending on the topics being discussed, get input on the draft agenda from other study team members.
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Execute Contract And Agree On Financials
Legal matters can be cumbersome but are extremely important. The purpose of the legal contract is to protect the interests of your organization and that of the KOL. The contract serves as a formal document to align on objectives and expectations for all parties involved. You also want to reimburse the KOL at fair market value based on her role and the contract will allow you to set financial commitments such as hourly rate and any financial caps.
In the US, government regulations in recent years have made it mandatory for companies to report direct and indirect benefits and payments to health care professionals (HCP). Therefore a signed contract is a must before you engage in any work with a KOL.
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Consider Business Meals
Business meals are a great way to build rapport with the KOL. When possible, you should try to schedule a meeting over a meal. Breaking bread together helps build trust and relationships. Meals also create an atmosphere for candid conversations which may not occur in formal meetings.
Government agencies or company policies regulate business meals with KOLs. Therefore it is important to understand rules around business meals before inviting a KOL to join you for a meal. Generally speaking, you want the meals to be reasonably priced, anywhere between $50 for breakfast to $125 for dinner is acceptable. Other ethical considerations include paying for KOLs meals only and not for their spouse, friends, or family members.
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Define A Communication Process
Effective communication with KOLs helps foster a positive working relationship. Many clinical trials last for several years. Therefore you want to ensure your clinical trial has a well-designed KOL communication process that is established at the start of the trial; refined and updated throughout the course of the study.
Developing a communication process involves creating a simple plan or charter that identifies primary and secondary points of contact for the KOL, frequency of communication, method of communication and the roles and responsibilities of all stakeholders including the KOLs. It is not unusual for a KOL to have more than one point of contact for a given project. Some examples of such a plan or charter include Steering Committee Charter and Publication Plan.
Additionally you want to have regular meetings (in-person and over the phone) with your KOL to discuss project status, progress, enrollment issues, clinical data review and publication strategy.
When you work with KOLs, action items will be assigned to you or your project team based on discussions and meetings. Taking detailed notes during these meetings can be extremely helpful to capture and assign action items.
Invite senior management to participate in KOL meetings. Some important meetings include discussions on trial design, primary endpoint data review, unanticipated safety signals or early trial close-out. These topics should be discussed in-person when possible.
It is also not uncommon for KOLs to elevate issues to senior leadership when the project is not moving forward as expected or if the KOL is unhappy with the performance of a study team member. Therefore it is important to ensure the KOL knows the “who’s who” on the senior management team.
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Aligning on KOL Expectations
An KOL engaged in your product, therapeutic area, clinical trial or company, will do her best to help you and your company. Like most human beings, KOLs do get busy with other commitments or may lose interest over time. It is your job to align with the KOL on her expectations. This will help ensure the KOL continues to remain engaged at all times.
Companies partner with KOLs to develop clinical trial protocols, get input on operational issues such as slow trial enrollment or scientific publications. KOLs generally are excited about working with companies on novel therapies and one-of-a-kind clinical trial. One key reason for such enthusiasm is that KOLs expect to be an author on publications and presentations that result from such projects. It will serve you a long way if you keep in mind the KOL’s ultimate motivation i.e. publications and presentations.
The opportunity to be a first author on a world-renowned peered review journal, present in front of a large physician community and be seen as an expert is what motivates KOLs. Therefore timely KOL alignment on all topics that has direct or indirect impact on publications and presentations is critical.
Some ways to align with KOLs is to hold regular teleconference calls, conduct in-person meetings and send well-crafted email updates. Interactions are more frequent calls during strategy and enrollment phase. In-person meetings can be conducted at local congresses, the KOLs hospital or office.
Hope you enjoyed Part I of the post on how to work with KOLs. In Part II, I will focus on strategic things you should consider when you work with KOLs. I’d like to thank Bradley White for taking the time to review and provide preliminary feedback on this blog post.
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