For most medical device companies, the speed and efficiency of clinical trials can make or break everything.
While we ultimately need FDA approval and go-to-market clearance, it’s the pace of your study that gives investors a sense of when you’ll be ready for commercialization. You could have a great product but if the trial stalls or falters, investors will drop out and your potentially life-changing treatment never comes to fruition.
So why does the patient recruitment process for clinical trials go so slow?
Whether it’s challenges with how the study sites operate, challenges with getting the right patients to respond, challenges in getting patients to stay the course — or all of the above— the pain points for clinical trial recruiters are many.
In our experience, there are two big challenges associated with recruiting patients for clinical trials — both have significant impacts on the pace and efficiency of your study. We’ll break them down here, then share guidance on how you can speed things up for a much faster path to commercialization.
Challenge #1: Sites aren’t equipped for patient recruitment
The reality is, most clinical trials rely on the study site (usually practices that conduct the studies) to handle patient recruitment.
For example, let’s say you have a new gastro device ready to be tested. A site with a large database of gastroenterology patients will likely be enlisted for recruitment.
The patient recruitment process begins in earnest, but is quickly bogged down because the database of contacts is old and unreliable. Not to mention the process is slowed down by the overwhelming task of mining the data and making call after call — usually tasked to just one employee.
In an attempt to speed things up, the site receives some advertising dollars.
However, most study sites are not advertising experts, which causes even more challenges, specifically related to ad buys and effectiveness.
Skilled at patient relations, researching and conducting the trials, marketing has never been in their purview. The result? They run a TV commercial that airs at midnight with the recruiter’s cell as the call back number who may or may not answer.
Challenge #2: Large recruitment firms bring in bad leads
Where recruitment at the site level may be a struggle, surely billion-dollar companies who specialize in recruitment can speed up the process, right? After all, they say you’ll only pay “when a patient enrolls in the study.”
A fixed investment for all involved with clinical trial recruitment, it seems like the perfect recruitment scenario for contract research organizations (CRO), pharmaceutical companies, device companies, sponsors, etc.
Unfortunately, this approach has hidden obstacles as well.
What many don’t know is that these recruitment firms specialize in getting leads for the lowest possible dollar amount. Sure, a site conducing diabetes research may get a quick influx of 10,000 leads, but how good can they be when half of them thought they were signing up to win a free jet ski?
With this approach, the “leads” may come pouring in, but the team must qualify the ones who are actually viable clinical trial candidates. Once again, the process comes to a screeching halt.
4 ways to accelerate your patient recruitment process
1. Make a deeper connection with patients
Let’s face it, most trial recruiters take the easy way out. There are a lot of hoops to jump through for Institutional Review Board (IRB) approval, so the conversations are very rote and clinical. There is a fine line to walk in order to remain IRB compliant, but working with trial recruiters who are trained in maximizing patient response by focusing on what the patient may be dealing with and why they are the perfect candidate is key.
Spending less time on the clinical aspect and more time on what people are actually feeling will always result in a higher conversion rate — and in a fraction of the time.
2. Reach patients others can’t
Where most sites use very broad databases and rely on staff to call and filter through countless ineligible patients, using a clinical trial recruitment service that offers an extensive network and prospect pool targeted to your study speeds up the process and delivers lower screen fail rates. Not to mention being a far more cost-effective approach.
3. Thoroughly prescreen patients
While prescreening is essential to an efficient and effective clinical trial, it’s not always an easy process. Time is a precious commodity at the research site, and having patients pre-screened and ready is critical to accelerating the clinical trial process. Through a comprehensive phone call conducted by a trained professional, be sure your prescreening:
- Has a well-written script
- Has the script and questions reviewed by the institutional review board (IRB)
- Asks questions that emotionally connect to the patient
- Discloses all applicable information to minimize dropout rates
- Is clear with the patient regarding expectations, next steps, and timeline
- Acknowledge possible resistance the patient may have to parts of the study
4. Only consider the right participants
As we mentioned earlier, a large pool of leads for your trial is worth nothing unless they are properly vetted and qualified to participate. With a reliable prescreening process, you should be confident that the vast majority of leads you see meet both inclusion and exclusion eligibility criteria.
The reality is, many studies close because they fail to reach enrollment targets. By starting with a data-driven analysis of your study to determine how many (and what types) of patients you’ll need, your recruitment process should only target and submit patients that will advance your study.
And since and enrolled patient does no good until they complete the study, always think of enrollment and retention as the same function. Be sure you communicate regularly and transparently after the patients are enrolled, and with the right patient identification, recruitment and retention strategies, your time to commercialization will be drastically reduced.
Ready to recruit patients for your clinical trial, faster?
Successful patient recruiting and retention saves time and resources. By enlisting the services of trial recruitment specialists, you’ll have a single point of accountability, and the ability to capture a far greater response from a higher percentage of qualified patients at a lower cost per patient.
TrackableMed’s dedicated recruitment solutions have one goal in mind: your trial success. You’ll never be slowed down by unreliable data because we know what it takes to maximize results and build a database of high-quality candidates.