This is Part II of How To Work with Key Opinion Leaders post. You can read Part I of the post here.
One of the most challenging and rewarding aspect of clinical trial management is working with Key Opinion Leaders (KOLs). KOLs are the scientific backbone of any clinical trial or therapeutic area. Sponsors and CROs interact with KOLs to realize a scientific vision through a robust clinical strategy. This ultimately leads to approval of a medical product and advancement in healthcare. The realization of this scientific vision comes at a cost, usually in the form of money and time. The delicate dance between science, clinical program cost and timeline can cause stress or a strong emotional response amongst all parties involved.
In this post, I will share ways in which you can prevent emotional turmoil and have an healthy working relationship with your KOL.
Focus On Providing Value
In most cases, a KOL is hired by the Sponsor or a CRO. The natural response then is that the KOL needs to provide value to the company and not the other way round. Well, it’s true that the KOL needs to champion the scientific vision as she may be getting paid by the company or recognition in the medical community. However if you are demanding, you will end up nowhere.
The truth of the matter is that you need the KOL as much as she needs you. KOLs are high educated people with medical degrees and generally paid well by their institution. Your reimbursement for their time is generally not a lot in comparison to what they are getting paid from other sources. In some cases, due to their accomplishments they don’t want to be “told” what to do.
In my experience, when you focus on providing value to the KOL, you will get a whole lot back in return. As an individual or a company, you can provide value by promptly responding to emails, conducting regular meetings as needed, providing email updates on the project status and progress, demonstrating that you are addressing their concerns and following up on any open action items assigned to you.
Being succinct in all forms of KOL communication can help you get done more with less. KOLs are busy people and don’t have the time to read long emails, slides with unclear or confusing content, or attend lengthy calls where everyone is digressing.
By getting input from other team members on slides, key messages, meeting agenda and other clinical trial related content, you can streamline your communication with the KOLs. You should also take extra time to review and re-word your written KOL communication and practice your presentation prior to a KOL meeting.
What I have observed is that the definition of “timeliness” varies across cultures. In some cultures, it is acceptable to be few minutes late. On the other hand, for example in the US, people are trained to show up early i.e. before the meeting start time. As a general rule of thumb, it is best to show up early. For teleconference meetings, dial in 5-10 minutes before the meeting start time. The additional time buffer will be helpful especially when there are unexpected technical issues with the conference line. For in-person meetings, showing up about 15 minutes prior to the agreed upon time can help you get set-up and calm your nerves before an important meeting.
Due to various business reasons, it can be challenging to be 100% transparent with external stakeholders such as your KOL. Being transparent means speaking the truth and not lying.
For example, if you are familiar with confidential information that may not be public knowledge yet, it is acceptable to let the KOL know that you are unable to provide additional information on a given topic as details are still being finalized.
Being transparent also means candidly discussing challenges you may be facing to realize the scientific vision set by your KOL. Many KOLs work at academic institutions and don’t necessarily face the same business challenges companies face. For this reason, walking them through the issue including any mitigation plans can go a long way to building trust with your KOL.
Stephen R. Covey, author of best-selling book The 7 Habits of Highly Effective People says, “Most people do not listen with the intent to understand; they listen with the intent to reply.”
When you are in meetings with KOLs, take the time to listen and understand. Too often, due to our beliefs, assumptions and emotions, we react to fast. Listening also makes KOLs feel that you are taking their input seriously.
Listening does not mean you need to be quiet. You can and should engaged in a dialogue with the KOLs. But don’t chime in for the sake of speaking up. Sometimes you may not know how to react in a spur of the moment. In such situations, you can always follow-up with an email or a phone call.
If you are not a good listener yet, don’t worry. Listening is a skill that can you can teach yourself overtime. The key is to be self-aware and recognize moments when you are not listening. This practice will make you a better listener.
Know When to Involve a KOL
A clinical director I worked with stated, “By involving a KOL in any clinical strategy discussion, you almost always will end up with additional feedback and changes that will cost you time and money.” KOLs are highly scientific in their approach to clinical research and many continue to have strong academic associations. Time and money generally are not their worry and rightfully so. They are also less concerned about the operational aspects of clinical research or your business priorities. For these reasons, it is important for you to know when to involve a KOL.
KOL input is necessary on the scientific aspects of clinical research such as protocol inclusion/ exclusion criteria, statistical strategy, patient safety. When it comes to clinical operations, such as site selection, monitoring and site management, the company should make decisions without KOL involvement. It is acceptable to inform the KOL of the company decision but KOL input may not necessary.
The one exception to this rule is clinical trial enrollment. KOLs can help boost trial enrollment by calling low enrolling sites or congratulating high enrolling site. Therefore involving KOLs in the enrollment is often valuable.
Learn To Manage Screw-Ups
It is possible that you or company may find yourself in a sticky situation with a KOL. This is completely normal as long as it does not happen repeatedly. The best course of action is to apologize right away and involve senior leadership at the company depending on the severity of the screw-up. If the situation is serious or complex, schedule time with the KOL for a face-to-face meeting, even if she is several hundred miles away. A face-to-face meeting makes a KOL feel valued and important. It also serves as an opportunity for the KOL to voice her concerns in-person rather than via email or phone.
How To Say No
Every once in awhile you may run into a situation where the KOL is pushing you and your team to achieve the impossible. For instance, you may be asked to achieve 100% patient follow-up compliance or increase the sample size of your newly designed trial from 100 patients to 2000 patients. There are likely scientific reasons for the KOL to do so. However limitations such as the size of your team, budget, or time constraints may make it difficult for you to act on the KOLs vision. In other words, it may not make business sense. It is in such times you need to say “No” to your KOL.
Before you say “No”, you want to objectively justify your decision and demonstrate that you have taken reasonable steps to act on the KOLs suggestion. Depending on the severity and sensitivity around the issue, you may want to consider involving senior management to back-up your “No”. Having difficult conversations on the phone or in-person is better than discussing via email. Lastly, be transparent with the KOL about your fears or concerns. You can share your concerns on a slide deck or document and present them to the KOL. Remove emotion and ego from the equation and your “No” will be well received.
Managing An Ineffective KOL
Sometimes priorities change for a KOL who was once engaged and enthusiastic. She does not respond to emails, is a no-show or late to important meetings or does not have the time to follow-up on action items. This can be a frustrating experience for you and the KOL.
Like any relationship, discussing the problem candidly can often lead to a solution. If choose to confront the KOL about her lack of engagement, please do so privately and not in front of an audience. If there are certain areas where you need KOL attention more than other, feel free to share your priorities with her. This prioritization may help re-engage the KOL.
KOLs can also be ineffective because of the actions by the sponsor or the CRO. For example, a pushy individual may rub the wrong way causing the KOL to completely shut down. Be prepared to receive such feedback from the KOL and adjust behavior accordingly.
In the rare occasion you need a discontinue your relationship with the KOL, you can always terminate your contract with her.
I hope you got much value from this blog post. Please feel free to share your feedback in the comments section below or hit the “Share” icon to share this post with others.