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.
