There is a common trend in clinical research patient
recruitment to tout the next big thing or widget that will most certainly help
a sponsor fully enroll their next study on-time and budget. While it is
certainly worthwhile to try and find new approaches to improve enrollment
rates, I have found that it is prudent to pay more attention to basic
principles in crafting a cohesive recruitment strategy for your trial.
While many studies and vendors at least pay lip service to
the practice of collecting metrics during a recruitment campaign, the number of
studies where this data is properly analyzed is relatively small. The rationale
for this assertion is certainly anecdotal, but plausible in part because of the
number of times that I have seen a sponsor or CRO communicate actionable
intelligence from a previous study (maybe three times in ten years).
There are several steps you can take to ensure that your
study is set up to produce actionable lessons learned at the end of enrollment:
Design a data capture infrastructure to
collect key metrics in advance of study launch
This seems intuitive enough, but
often recruitment metrics are not planned far enough in advance to accommodate
any special considerations for a specific study. If you are relying solely on site-based
reporting to measure the success of any initiatives, then it is vital to try
and standardize your metrics to some degree up front. Otherwise, you may be
stuck trying to aggregate varying levels of data between your sites.
For instance, some sites will
precisely record every minor detail in the patient engagement process on a
spreadsheet or other database, from first contact, the numbers of times they
have followed up with the contact, to any appointment no-shows. Some sites, on
the other hand, will be less exact with how they record this information. It is
important to make sure you know what metrics you want to capture and
communicate the expectations to all sites before FPFV.
Even if you are employing a CRO or
patient recruitment vendor to capture data for a centralized campaign, it is
still a good idea to finalize what they will be measuring and how in advance of
study launch. These organizations often have template systems in place that
capture the same metrics for every campaign they support. Be sure to ask about
this up front and ensure that their metrics platforms meet your needs.
Ensure that reporting begins early and
often in the recruitment campaign
It is a good idea to set the
standards for reporting early before the study begins, as well. Most studies
have regular check-in meetings between sponsor and vendor and/or sites. Use
these discussions as an opportunity to create a reporting interval where
current recruitment data can be shared and analyzed by the team. These forums
can also be a valuable way to dig deeper into the data by generating regular
reports that will allow you to make course corrections to enrollment strategy,
if needed.
There are a number of ways to
accomplish this within the confines of a study. It all depends on what your
data requirements are. Perhaps you want to keep close tabs on cost per referral
or screening. Or maybe you are curious about the relationship between site
communication (eBlast, phone call, etc.) and screening activity. These are all
things that can be measured and reported on throughout enrollment if planned
for.
Don’t be afraid to call more
frequent meetings or create reports outside of the normal schedule if it will
benefit enrollment by prompting timely strategy decision-making. Your
enrollment campaign should not be created in a vacuum. Use metrics and
reporting to inform how you spend your recruitment dollars.
Insist on a robust final analysis meeting
On more than one occasion, I have
encountered objections from key study leaders about the need or benefit of a
final analysis meeting.
But why have one in the first
place?
Even if recruitment goes
exceedingly well for a study, any final analysis should be able to determine
some lessons learned from a recruitment campaign, if the right metrics were
captured from the beginning. Whether you are a project manager at a sponsor,
CRO, site or recruitment vendor, the end of enrollment for any study should
include a thorough review of every action that took place in trying to recruit
patients to the trial, in an effort to improve those efforts in future
campaigns.
Invariably, there will be
naysayers who might decry the need for a long meeting to review reports and
discuss lessons learned. Ignore these detractors and insist on conducting a
thorough final analysis meeting. It will be time well-spent.
Deliver a thorough after-action report,
including any key learnings from the final analysis meeting
At the end of any meeting, it is
supremely important to recap the discussion and highlight any pertinent action
items that were flagged. Once all key learnings are catalogued, a final report
should be compiled, including any and all data and takeaways, for distribution
to the entire team. If you are talking about a Phase II trial, the report
should detail how these learnings can be applied to the next trial. If there are
no further studies to leverage, then you should go the extra mile to apply the
lessons learned to a therapeutic area or similar type of study where appropriate.
Paying close attention to metrics and reporting is not quite
as sexy and cutting edge as touting the latest new trends in patient
recruitment. And yet, all too often, data is overlooked or not emphasized
enough when developing strategy for completing enrollment on time. If used
effectively, reporting can be a way to build rapport and engage the entire
study team that will benefit your entire clinical operations infrastructure.
