Long before your study’s first randomization, before the first screening visit is scheduled, even before the very first patient is referred, sponsors have already invested upwards of $2 million just in selecting and training qualified study sites. The magnitude of this investment shouldn’t come as a surprise: proper site selection dramatically and directly impacts the success of clinical trial enrollment. These impacts are magnified when only a portion of sites are open, as continues to happen amidst the pandemic.
After months and millions of dollars spent selecting, qualifying, and activating sites, you expect strong enrollment numbers from each. But the reality is, some sites are going to struggle, and many not reopen fully for months. Whether they’ve overestimated the number of active patients in their database, have a sudden staff shortage (hello, COVID-19), or are slow to contact referrals, you know not all your sites are going to hit their milestones. So, what do you do? Do you invest additional time and resources to get underperforming sites back on track? How can you boost performance at open, responsive sites to help offset the impact of closed or otherwise impacted sites?
Identifying the Barrier(s)
The answer is complex, but given the up-front investment in activating each site, it’s worth exploring. In our experience, all sites want to do well and reach their enrollment milestones—but now more than ever, some need extra help to understand how to be successful. Effectively identifying enrollment barriers is usually a matter of asking smart questions while remembering to give the site the benefit of the doubt. Some enrollment barriers can’t be solved, but some can. Weighing these barriers against each other will guide your decision on how to proceed with recruitment in active study site(s).
First, look to the progress the site coordinator has made, are they trying? Is the site contacting patients but not scheduling appointments? Is the site’s screen-fail (SF) rate higher than the SF of the overall study? (What’s the screen-fail rate compared to the rest of the study?)
Non-Solvable Barriers
Barriers we can’t fix include site location (is it difficult to get to? Does it have ready public transit access or covered parking? Is it located in a densely populated area or in a city that remains under partial lockdown?), site atmosphere (are the waiting and exam rooms comfortable and set up for social distancing? Does it have free WiFi or a TV in the reception area?), and appropriate site staff levels (is the site open for appointments? Is it unable to handle a high referral volume because of staffing? Or do they not have the time to comb carefully through their database?). All of these are very real problems, and each has an impact on a patient’s experience during study visits, and therefore whether or not a patient enrolls (or stays enrolled) in your trial.
Solvable Barriers
Barriers that we can have a positive impact on may be harder to identify, but hold the key to improving recruitment. Some of these barriers are about patient experience: How long is a patient waiting to be contacted by the site? And when they are contacted, is the study coordinator friendly and accommodating? Are hygiene procedures and social distancing measures being communicated clearly to patients? Is study information being communicated in a patient-friendly manner that is easy to comprehend and not overwhelming? Is the PI available to address patient concerns, especially during the consenting process? Other barriers are about site staff efforts and bandwidth: How many competing studies does the site have? How much time are coordinators dedicating to patient recruitment efforts? Is the site making efforts to utilize study materials they were provided?? And some barriers are about the protocol: Is tight I/E criteria driving up the site’s screen failure rate? Are patients disqualifying at screening due to a specific diagnostic?
Investing in Site Performance
Your patient recruitment partner should actively be asking many of these questions, and likely has a good enough relationship with study coordinators to get honest answers about how a site is doing. Once the above barriers have been identified and discussed with the site coordinator, you and your recruitment partner must weigh them against each other. If a site is mostly suffering from non-solvable barriers, investing more time and money into recruitment at that site may not be worthwhile. But if a site has a combination of solvable problems, and you have a recruitment partner with a strong site engagement team, you can almost certainly turn that site back into a productive recruiter.
Scenario #1
You have discovered that the site coordinator has contacted 20 patients, but has not scheduled any screening visits.
Solution:
There’s a good chance that there is a breakdown in communication. Try conducting a mock patient conversation with the site coordinator and see if you can pinpoint where the breakdown is occurring. Once you have identified where the disconnect is, provide talking points or a script to help the site coordinators introduce the study more effectively or more empathetically. It is especially critical that COVID safety procedures are clearly outlined for patients so they feel comfortable scheduling a visit.
Scenario #2
During a phone call with the site coordinator, you learn that they are dealing with two other competing studies and your study isn’t a priority.
Solution:
Make more effort to keep your study top-of-mind with increased site contact. Ensure study flyers and brochures, especially HCP- or site-facing materials, are displayed where study staff can see them regularly. If there’s a specific reason your study isn’t a priority (more challenging I/E criteria or arduous study design), try to address it with talking points, or consider providing additional site support materials to help with the consenting process.
Scenario #3
Active sites are not implementing recruitment tactics properly.
Solution:
Coach sites on how and where to place their study materials and how to best utilize local advertising tools. Assist the site with community engagement efforts, such as hosting an open house, attending a local event, or building referral networks. In some cases, having your recruitment partner do this on behalf of sites can improve recruitment rates by upwards of 20%.
Results
When solving for barriers, it’s critical to keep the patient’s journey and the site coordinator’s workload top of mind. Site coordinators are often over-burdened and over-worked, particularly amidst limited office hours and reduced staffing scenarios. Sometimes, improving recruitment and effort is as simple as giving sites a little more attention and showing them that their work is important. We know this because in our experience, it works. When study sites feel valued and supported by the sponsor (and the sponsor’s recruitment partner), enrollment rates improve.
