As an avid runner, I am
constantly obsessing about race times, trying to find ways to get faster even
though I am nearing the tail-end of my running “prime”. In spite of
professional and family demands, I sometimes think I can still run fast without
putting in the training needed to shave minutes or seconds off of my personal
best times, from 5K to marathon. However, with years of racing experience under
my belt, I know that it just isn’t possible to make significant time gains
without the proper work. Unfortunately, too often clinical trial sponsors make
the same mistaken assumption when it comes to recruitment planning for their
studies.
There continues to be a pervasive
belief among sponsors and CROs that every therapeutic area has a predetermined
selection of tactics that will help enroll a trial on time. Similarly, those
same beliefs hold that you are not qualified to provide successful enrollment
support for a study unless you have had previous experience on another similar
trial. Instead, the focus should be on the process of developing a
strategy that is best suited to maximize ROI and meet enrollment goals on time
and on budget.
So, even generally speaking, what is the right mix of
tactics to use to efficiently enroll your next study? Since we have established
that there are no magic bullets to apply (i.e. print should be used on any
patient audience over the age of 60+, etc.) universally across trials, there
are some general tenets that should be adhered to when deciding what
recruitment initiatives are going to work best for your study.
1) Know your target audience
More than anything, it is
imperative that everything you do, from messaging to engagement medium (media
or online advertising, outreach, etc.), should be executed with the target
audience in mind. Things like age, gender, ethnicity, and other demographics
should be top of mind when developing study materials or advertisements. While
there are certainly several other factors to consider, this is the most
important in determining your recruitment strategy. Really knowing your target
audience is not the same as simply having executed a recruitment campaign for a
similar indication. The variables noted above change with every study, and it
is critical that you understand them in an effort to know who the patient
audience truly is for a given study.
2) Never go ‘all-in’ with one initiative
Even in the most desperate rescue
situations, it is never smart to put all of your eggs in one basket and rely on
a single recruitment initiative to enroll your trial. Even in situations where
you are confident that one medium (say, TV advertising) is going to provide
enough referrals to meet your goal, until you have empirical evidence that an
initiative is definitively performing the way you need it to, it does not make
sense to spend significant amounts of money on one tactic. It is better
strategy to pilot an initiative when possible. When that is not feasible, it
still makes sense to stagger the rollout of your tactic in a way that allows
you to collect data on its effectiveness before investing large amounts of
money that could result in a poor return on investment.
Avoiding an ‘all-in’ strategy does
not mean that it makes sense to throw money at a number of different tactics
simultaneously. It is still prudent to do your homework and settle on a focused
strategy that will efficiently enroll your study. My experience has been that a
diversified suite of 2-3 tactics are generally sufficient to accommodate
variable site capacity and ensure you are effectively attracting patients to a
trial without breaking your budget.
One of the biggest reasons that it
is next to impossible to accurately predict the performance of a given
initiative is that no matter how successful you are in generating clicks, calls
or referrals, unless the sites act on those leads and convert referrals into
screenings and enrollments, your tactic may fall short of expectations. Which
means you should…
3) Communicate with your sites
As any seasoned clinical research
professional can attest, no two sites are created equal. Some sites have robust
recruitment teams that can handle dozens of referrals per day, while there are
still some study centers that struggle to triage a dozen leads in a week. This
disparity can be frustrating, but some simple upfront work to understand site
capabilities along with robust engagement to manage expectations can go a long
way in mitigating this issue. Any recruitment tactics you move forward with
should be done so with these issues in mind. As an example, don’t run TV ads in
a large market where you know you will get a lot of referrals, but have a site
that might not be able to handle them.
Reaching out to the sites ahead of
a recruitment campaign will not only allow you to determine their capabilities,
but will also help you build rapport that can keep your trial top of mind and
ultimately result in those sites working harder to enroll your study. You can
make the sites feel even more invested by working with them to customize a
given tactic in their market. Whether that is taking their feedback on which
broadcast outlets to use or local patient advocacy groups to engage, this can
go a long way in motivating your sites to go the extra mile for your study.
One potential communication
pitfall to be mindful of when talking to sites is that they can sometimes tell
you what they think you want to hear. This is where having data about how well
your sites are executing on a given recruitment initiative can be very
beneficial to give you the full picture, and objectively assess site
performance.
When a site or recruitment vendor says, “We’ve got lots of
experience recruiting in this therapeutic area. We know exactly what will work
to enroll your study”, you should be wary. No two studies are the same, and
ultimately it comes down to carefully developing and executing a plan based on
the myriad of variables that exist in any given study. While experience is
helpful, it is more important to focus on the process of developing a sound
strategy to ensure a successful recruitment campaign. Being mindful of this
will help you cross the enrollment finish line of your next clinical trial in
record time.
No comments:
Post a Comment