The success of these trials hinges on finding and enrolling the right patients in a timely manner. Eben Scanlon, chief customer officer at OneStudyTeam, has spent over two decades working in clinical data management and recruitment strategy. In this interview, Scanlon shares insights on how biopharma companies can optimize patient recruitment by collaborating with specialized vendors and using data to refine their strategies.
Why is it crucial for biopharma companies to collaborate with specialized recruitment vendors?
In order to accelerate recruitment timelines and optimize your recruitment spend, you need to go through channels that are designed to reach the right patients for your trial. With recruitment vendor selection, that means prioritizing vendors who have a proven ability to engage candidates that meet your specific patient population needs. That could look like working with one vendor who specializes in reaching diverse populations, and another vendor who specializes in reaching candidates within a particular therapeutic area. Specialized vendors are consistently testing and optimizing messaging that reaches and engages their target audience, so they’re adept at sending active and interested patient referrals to research sites.
One of the most important outcomes of working with these vendors is reducing recruitment burden for research sites. Sites have their own methods for recruiting patients locally, from social media outreach to building relationships with referring providers. But site teams can allocate only so much time to recruitment activities – their most important role is building relationships with patients as they move through enrollment and then provide the best care possible to those patients during the treatment phase. Sites need their schedules freed up to schedule timely visits with each patient per protocol, to be available to answer questions and address concerns during follow-up, and to give patients their full, unrushed attention during visits.
What specific skills or expertise should these vendors possess to be effective?
Free up critical time for your sites by working with specialized recruitment vendors who have proven expertise in (a) referring high-quality patients to sites in your specific therapeutic area and per your specific trial goals such as diversity goals, and (b) pre-screening patients to ensure initial eligibility and to reduce the number of remaining pre-screening and screening tasks for site staff. The best recruitment vendors can articulate their strategies for reaching the right candidates with the right messaging online or in-person. They can also present tactics for engaging those patients with the right information about clinical trials and about your clinical trials, and for assessing initial eligibility.
How does a strong pre-screening process contribute to the efficiency of patient recruitment?
No matter how skilled your recruitment vendors are, enrollment success (and acceleration) is dependent on robust pre-screening practices you set with your site teams. You can do this early – consider discussing pre-screening requirements during site qualification visits for each trial. Ideally, the expectation you set is that sites will digitally share de-identified pre-screening data with you throughout recruitment and enrollment. With intuitive technology in place that fosters automatic data-sharing between sites and sponsors, you can enable sites to complete digital checklists of pre-screening questions based on the trial protocol. Educate sites about the importance of basing questions off of eligibility criteria and diversity status, and conducting questionnaires online or by phone to limit extra visits and save patients valuable time.
When sites fill out these checklists for each patient during pre-informed-consent visits or chart review, you’re able to track enrollment progress and identify addressable barriers to enrollment early, before timelines are affected. At the same time, sites are building a rich database of patient information, which means they can more easily match patients to another trial if they are ineligible for the current trial. Pre-screening now saves time on patient identification for other trials later.
What metrics or data points are most important to track for adjusting recruitment strategies?
It’s just as important to monitor pre-screening data from your recruitment vendors as it is to monitor pre-screening data from your sites. With an eye on the right recruitment metrics, you can identify recruitment delays while they are happening and adjust tactics before timelines get off track. Not only does this ensure you’re maximizing your recruitment spend, but it can reduce overall costs for your trials while increasing accessibility to patients.
To do this, metrics to evaluate during patient recruitment campaigns should include the number of referrals from your vendors that make it to informed consent and the specific reasons referrals are failing pre-screening or declining to participate. You should also track which referral mediums are performing best, the effectiveness of vendor-based and site-based recruitment campaigns, and how quickly sites act on referrals from vendors.
With insights like these, you can make necessary adjustments, such as revising inclusion or exclusion criteria that are disproportionately affecting patient enrollment or specific subsets of patients. You may also need to address perceived patient burdens, like extensive travel time or associated risks, while prioritizing patient sources and campaigns that show the strongest performance.
Can you provide examples of how specialized vendors have successfully improved recruitment outcomes in specific therapeutic areas?
We worked with recruitment vendor CSSi on an endocrinology/heart failure study that was struggling with recruitment. Sites were having a hard time finding patients, and when they did find them, the patients were often not qualifying. Additionally, the consent rate was low. Through the data they were seeing, the sponsor recognized that this was an issue and decided that a rescue campaign was needed to turn the trial around. They turned to CSSi and OneStudyTeam to help solve this problem.
Sites started receiving referrals within 48 hours of the sponsor notifying the partnership that this is something they wanted to do. Because of the recruitment data provided by StudyTeam, our patient enrollment management platform, CSSi was able to optimize their campaigns repeatedly and quickly, so their referrals garnered a 7% consent rate, which is more than 5% higher than what sites were seeing with their own self-sourced patients. CSSi sent in almost 1,500 patients to the sites, 100% of which were acknowledged and worked on by sites. Overall, there were 13 randomizations for the successful rescue campaign.
