The Role of Key Opinion Leaders in Clinical Trials

A group of us were watching an American football game last weekend.  We witnessed a wide receiver catching a pass and proceeding to dance around, looking for an opening to run up the field.  He must have run 100 yards by the time that he was tackled – he looked exhausted, pulling himself out for the next play only to be met by a waiting head coach, screaming like crazy.  The player proceeded to lose yardage despite the fancy footwork and dazzling moves.  The announcer on the broadcast was silent for a moment, then made the following statement: ”Players learn in pee wee football that the goal is to run North and South, not East and West.”

This vignette brought to mind a recent study experience, where a biotechnology company with terrific thought leaders and Advisory Board contributors were implementing their clinical trial for a novel compound addressing an area of unmet medical need.  Technology was utilized to capture case report form data, randomize subjects, and integrate third party sources – all in an effort to continually clean the entries made by the sites and provide as comprehensive a report each month for all participants to review.  After the initial first pass of information was entered, a comprehensive review took place, which everyone enjoyed.  They scrutinized all of the information, evaluated the patients medical histories, etc.
The thought leaders noticed some interesting information, perhaps a trend, and inquired about exploring it further – they were held in high esteem in their field, and could heavily influence the use of this product if approved.  So, the clinical team implemented the changes, causing further delays in the study, causing major changes to the database, and leading to additional time and cost impacts.  Upon further review by the clinical team, it may have been good information for a publication by a thought leader, but had no impact on the primary and secondary endpoints – the goal for the study.

So we see evidence here of the relationship to our wide receiver, maneuvering their best to gain more yardage when just turning and running up the field would have been the more obvious choice.  Key Opinion Leaders (KOLs) fill a needed and valuable role in designing protocols, answering medical questions, review and analyze data, and interact with key investors to confirm the commitments to the trial and its benefit to patients.  Their input during the course of the trial should be assessed on its impacts to the key goals of the study and direction of the program.

Granted there are many great ideas and thoughts provided by KOLs, no doubt.  But will they lead us “North and South” or “East and West”?  Some suggestions may be better served as Investigator-Initiated Research studies to allow further evaluation and possible publication, maybe some offer thought-provoking discussion that can be further evaluated at a later date.  In all, the focus on the endpoints and the goal line will help to keep you running North and South, getting ever closer to the ultimate goal – an approval.

Comments

  1. Well said! Key Opinion leaders play a vital role in the development of pharmaceutical organization. Hence it is recommended that the organization take necessary steps for building KOL relationship and managing them effectively.

  2. charles says:

    Thanks for sharing this post, its a good information to us Key opinion leader management role will be showned

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