Partnering with the right CRO to maximize recruitment efficiency
By Kathryn E. Vinson, MS, CCRC

If you’ve worked in clinical research for almost any length of time, you have undoubtedly run up against the trial that feels impossible to recruit. Whether it’s a hypertension study with difficult inclusion criteria or an arthritis study that excludes participants over the age of 70, we’ve all been there at one point or the other. In these cases, recruiters find themselves really having to “think outside the box,” as the old cliché goes.

Studies such as these can present with similar difficulties as recruiting trials for rare or orphan disease trials – as you find yourself looking for the proverbial needle in a haystack. With the outbreak of COVID-19, talk of rare and orphan disease trials have dominated many discussions in the clinical research world. We here at DZS would like to take some time to discuss recruitment strategies that have been successful in finding unique trial participants, and how our team’s knowledge can help you meet your recruitment goals.

Rare/Orphan Disease Designation
The US FDA is fairly strict in their definition of a rare or orphan disease. In order to qualify for this designation, as well as the benefits of running a trial under the same, a disease must affect no more than 200,000 persons in the US per year. There is a caveat to this: if the disease affects more than 200,000, the developer should have no reasonable expectation of recovering research costs via sales after marketing. To put these numbers into perspective, if we estimate the US population at roughly 330 million people – we are talking about conditions which affect 0.06% or less of the population. So, we are talking about a pretty small recruitment pool.

Recruiting Special Populations
When it comes to orphan disease trials, it is vital for sponsors and sites alike to partner with a CRO that is experienced in recruiting these delicate trials. Here at DZS, we not only have extensive experience in the conduct and management of rare and orphan disease trials, but our global network of partner sites can help extend the reach of your trial worldwide.

Even the most seasoned site recruitment team may run up against walls utilizing strategies such as chart screening, community outreach, and rounding with specialists. It is vital for sites and sponsors to be realistic in their recruitment goals. We would far prefer to run a study at four sites that can meet their goals than try only two sites and see them struggle.

While the sites have plenty of responsibility in recruitment, we also know from years of hard-earned experience that protocol language is key in recruiting these special populations. Our project managers are ready to assist sponsor teams in not only the development of clinical protocols, but also to work as a liaison between sponsors and sites should the need for protocol amendments arise.

By partnering with the right CRO, sponsors can rest assured that the right team is assembled to efficiently recruit rare and orphan disease trials. Here at DZS, our team of seasoned research professionals have years of experience in the conduct of these specialized trials. Reach out to one of our project managers to see how DZS Clinical Services can be your “Your Direct Line to Maximized Trial Efficiency.”

Sources:
https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=718f6fcbc20f2755bd1f5a980eb5eecd&mc=true&n=sp21.5.316.c&r=SUBPART&ty=HTML#se21.5.316_120