Finding help when your study is in trouble can be tricky, but not impossible
By Kathryn E. Vinson, MS, CCRC
When we begin any new trial, we are all filled with joy and optimism that it will recruit quickly and efficiently. For the most part, in most trials, this is how it turns out. But even the most experienced research site can come up short on accrual numbers. The reasons for this recruitment failure are multitude – some can be addressed with a monitoring visit or perhaps a protocol amendment is needed if the troubles are study-wide. Sadly, sometimes it just doesn’t work out, and a sponsor finds themselves in the position of needing to find additional “rescue” sites to reach recruitment goals.
Here at DZS Clinical Services, we have helped many sponsors when they find themselves in this unfortunate position. Today, we’d like to talk about some factors that may necessitate the use of rescues sites, and how DZS is prepared to alleviate these issues.
Small Recruitment Pool
It happens more often than we’d like to admit, but many sites become overly ambitious with their ability to recruit a trial. These may be new sites that simply overestimate their ability to recruit, or the targeted population may be small to begin with. Once traditional and even “out-of-the-box” recruitment strategies have failed, a rescue site may be needed to take on the additional recruitment needs.
Occasionally a study will start out with what seems to be reasonable inclusion/exclusion criteria, but upon execution of the trial, all sites seem to be experiencing a higher than expected screen failure rate or even an inability to find volunteers to screen. In many cases, sponsors may consider protocol amendments to address these difficulties, but amendments aren’t always feasible.
This may be one of the most extreme reasons for the need of a rescue site, but it does happen and must be considered. Site closures happen for a multitude of reasons, from a site choosing to withdraw from a study, to pandemic related closures (such as we’ve seen with COVID-19), to the full closure of a site by a regulatory body.
While all of these circumstances differ, they have one thing in common: the need for additional sites. The DZS team has years of experience in assisting sponsors in these types of situations. Our position as a leading CRO gives sponsors access to:
- Industry leading clinical trial management software in the Insight Platform. Here sponsors benefit from study metrics tracking for up to date actionable data on recruitment trends.
- Project managers with decades of combined experience in oversight of difficult to recruit trials. These leaders bring a global reach to your trial with the ability to conduct trials worldwide (with proper regulatory approvals).
- A network of partner research sites experienced in the successful recruitment for rare and orphan disease trials. More information on that can be found in “A Needle in the Haystack?“.
- Protocol developers and data managers, backed by a uniquely diverse medical advisory board, that are ready to assist your team with any protocol amendments that may be needed.
Although we all hope that the need for rescue sites never arises in our trials, it is almost a certainty that it will eventually happen one day. When this day comes, you can rest assured that the seasoned professionals at DZS Clinical Services are ready to hit the ground running in the race to fill your trial.