Monday, February 10, 2014

What Is the Right Mix of Recruitment Tactics for a Study?

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.      

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